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Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: Randomized Controlled Pilot Study

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Background: Patients with chronic pain often have limited access to comprehensive care that includes behavioral pain management strategies. Virtual reality (VR) is an immersive technology and emerging digital behavioral pain therapy with analgesic efficacy for acute pain. We found no scientific literature on skills-based VR behavioral programs for chronic pain populations. Objective: The primary aim of this study is to evaluate the feasibility of a self-administered VR program that included content and skills informed by evidence-based behavioral treatment for chronic pain. The secondary aim is to determine the preliminary efficacy of the VR program in terms of average pain intensity and pain-related interference with activity, stress, mood, and sleep, and its impact on pain-related cognition and self-efficacy. The tertiary aim was to conduct a randomized controlled trial (RCT) and compare the VR treatment with an audio-only treatment. This comparison isolated the immersive effects of the VR program, thereby informing potential mechanisms of effect. Methods: We conducted an RCT involving a web-based convenience sample of adults (N=97) aged 18-75 years with self-reported chronic nonmalignant low back pain or fibromyalgia, with an average pain intensity >4 over the past month and chronic pain duration >6 months. Enrolled participants were randomly assigned to 1 of 2 unblinded treatments: (1) VR: a 21-day, skills-based VR program for chronic pain; and (2) audio: an audio-only version of the 21-day VR program. The analytic data set included participants who completed at least 1 of 8 surveys administered during the intervention period: VR (n=39) and audio (n=35). Results: The VR and audio groups launched a total of 1067 and 1048 sessions, respectively. The majority of VR participants (n=19/25, 76%) reported no nausea or motion sickness. High satisfaction ratings were reported for VR (n=24/29, 83%) and audio (n=26/33, 72%). For VR efficacy, symptom improvement over time was found for each pain variable (all P<.001), with results strengthening after 2 weeks. Importantly, significant time×group effects were found in favor of the VR group for average pain intensity (P=.04), pain-related inference with activity (P=.005), sleep (P<.001), mood (P<.001), and stress (P=.003). For pain catastrophizing and pain self-efficacy, we found a significant declining trend for both treatment groups. Conclusions: High engagement and satisfaction combined with low levels of adverse effects support the feasibility and acceptability of at-home skills-based VR for chronic pain. A significant reduction in pain outcomes over the course of the 21-day treatment both within the VR group and compared with an audio-only version suggests that VR has the potential to provide enhanced treatment and greater improvement across a range of pain outcomes. These findings provide a foundation for future research on VR behavioral interventions for chronic pain. (JMIR Form Res 2020;4(7):e17293) doi: 10.2196/17293
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Original Paper
Self-Administered Skills-Based Virtual Reality Intervention for
Chronic Pain:Randomized Controlled Pilot Study
Beth D Darnall1, PhD; Parthasarathy Krishnamurthy2, MBA, PhD; Jeannette Tsuei3, MA; Jorge D Minor4, MD
1Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, CA, United States
2C.T. Bauer College of Business, University of Houston, Houston, TX, United States
3AppliedVR, Inc, Los Angeles, CA, United States
4L.A. Pain & Wellness Institute, Los Angeles, CA, United States
Corresponding Author:
Beth D Darnall, PhD
Department of Anesthesiology, Perioperative and Pain Medicine
Stanford University School of Medicine
1070 Arastradero Road
Suite 200, MC 5596
Palo Alto, CA, 94304
United States
Phone: 1 (650) 725 9642
Email: bdarnall@stanford.edu
Abstract
Background: Patients with chronic pain often have limited access to comprehensive care that includes behavioral pain management
strategies. Virtual reality (VR) is an immersive technology and emerging digital behavioral pain therapy with analgesic efficacy
for acute pain. We found no scientific literature on skills-based VR behavioral programs for chronic pain populations.
Objective: The primary aim of this study is to evaluate the feasibility of a self-administered VR program that included content
and skills informed by evidence-based behavioral treatment for chronic pain. The secondary aim is to determine the preliminary
efficacy of the VR program in terms of average pain intensity and pain-related interference with activity, stress, mood, and sleep,
and its impact on pain-related cognition and self-efficacy. The tertiary aim was to conduct a randomized controlled trial (RCT)
and compare the VR treatment with an audio-only treatment. This comparison isolated the immersive effects of the VR program,
thereby informing potential mechanisms of effect.
Methods: We conducted an RCT involving a web-based convenience sample of adults (N=97) aged 18-75 years with self-reported
chronic nonmalignant low back pain or fibromyalgia, with an average pain intensity >4 over the past month and chronic pain
duration >6 months. Enrolled participants were randomly assigned to 1 of 2 unblinded treatments: (1) VR: a 21-day, skills-based
VR program for chronic pain; and (2) audio: an audio-only version of the 21-day VR program. The analytic data set included
participants who completed at least 1 of 8 surveys administered during the intervention period: VR (n=39) and audio (n=35).
Results: The VR and audio groups launched a total of 1067 and 1048 sessions, respectively. The majority of VR participants
(n=19/25, 76%) reported no nausea or motion sickness. High satisfaction ratings were reported for VR (n=24/29, 83%) and audio
(n=26/33, 72%). For VR efficacy, symptom improvement over time was found for each pain variable (all P<.001), with results
strengthening after 2 weeks. Importantly, significant time×group effects were found in favor of the VR group for average pain
intensity (P=.04), pain-related inference with activity (P=.005), sleep (P<.001), mood (P<.001), and stress (P=.003). For pain
catastrophizing and pain self-efficacy, we found a significant declining trend for both treatment groups.
Conclusions: High engagement and satisfaction combined with low levels of adverse effects support the feasibility and
acceptability of at-home skills-based VR for chronic pain. A significant reduction in pain outcomes over the course of the 21-day
treatment both within the VR group and compared with an audio-only version suggests that VR has the potential to provide
enhanced treatment and greater improvement across a range of pain outcomes. These findings provide a foundation for future
research on VR behavioral interventions for chronic pain.
(JMIR Form Res 2020;4(7):e17293) doi: 10.2196/17293
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KEYWORDS
chronic pain; virtual reality; behavioral medicine; self-management; mobile phone; randomized controlled trial
Introduction
Background
The US Department of Health and Human Services [1,2], the
Institute of Medicine [3], the National Institutes of Health, and
the Centers for Disease Control and Prevention have called for
the integration of evidence-based behavioral medicine strategies
into the treatment of acute and chronic pain. These unified
recommendations reflect a common understanding that pain is
a biopsychosocial experience that requires a comprehensive
treatment approach to equip individuals with skills to actively
self-manage pain and symptoms [4].
Evidence-based behavioral pain treatments include cognitive
behavioral therapy (CBT) for chronic pain [5-7], acceptance
and commitment therapy [8], and mindfulness-based stress
reduction [5,6]. Treatments typically include didactic content,
goal setting, and experiential skills practice within sessions and
skills practice between sessions. Effective chronic pain
management techniques include biofeedback and relaxation
training, with the latter being the mainstay of every effective
behavioral treatment for chronic pain [9]. Evidence-based
behavioral medicine treatments are commonly delivered
individually or in group format, during treatment classes or
sessions that are 1 to 2 hours in duration, with a course of
treatment lasting 8-11 weeks [7]. Behavioral treatments for
chronic pain have been shown to be effective for reducing pain
bothersomeness [5,6], symptoms of depression [7,8], and
pain-specific cognitive and emotional distress (eg, pain
catastrophizing) [5-7], although these treatments have not been
effective in reducing pain intensity. Behavioral treatments have
also been shown to be effective for improving pain-related
self-efficacy or confidence in one’s ability to self-manage pain
and engage in meaningful activities [5,6].
Despite the availability of efficacy data for behavioral
treatments, multiple barriers may prevent patients from broadly
accessing low-risk, integrative, nonpharmacologic pain
self-management tools that address the psychosocial aspects of
chronic pain [10]. Such barriers may include few skilled local
therapists, poor insurance coverage, copayments associated with
clinic visits, travel costs, and treatment time [10]. Even when
delivered to participants at no cost, in-person behavioral
medicine treatments can have poor patient engagement [11],
thereby suggesting that new methods of treatment delivery are
required to meet the needs of a broad range of patients.
Accordingly, research has demonstrated preliminary efficacy
for an ultrabrief, single-session, skills-based behavioral
treatment class for chronic pain [12] as well as for mobile health
teleconference-delivered multisession behavioral pain treatment
[13]. Although both options offer new conveniences and
possibly expanded access to care, particularly for patients with
mobility limitations, the patient remains dependent on a therapist
for the delivery of the treatment.
Digital therapeutics offer independent, home-based, on-demand
access to behavioral treatment for acute and chronic pain. For
instance, a brief, web-based, 90-min, skilled-based pain
treatment was shown to reduce postsurgical opioid use in women
who underwent surgery for breast cancer [14]. For chronic pain,
digital multisession interventions have been shown to be
effective [15-17]. Despite these successes, any one modality
will not meet the needs of everyone; indeed, even web-based
pain treatments that are offered at no cost have <60%
engagement rates [14], thus underscoring the need to offer a
diverse range of accessible treatment options for chronic pain
and, in particular, to identify treatments that may yield superior
outcomes.
Virtual reality (VR) has emerged as an effective digital treatment
for acute pain. With VR, the user wears a headset that fully
restricts the vision field to the content displayed inside the
headset screen, and auditory perception is directed to the audio
delivered through the device (although not fully restricted;
Figure 1). VR provides a multisensory, 3D immersive
environment that stimulates the visual, auditory, and
proprioception senses, thus engendering the perceptual
experience that one is physically located inside and engaged
with the virtual environment they are viewing [18,19], such as
swimming with dolphins (Figure 2). VR has been used in
numerous clinical settings and health conditions to treat anxiety
and mental disorders [20-22], aids physical rehabilitation
[23,24], and supports postsurgical recovery. Evidence suggests
that VR is effective for managing acute pain, including pain
elicited during medical procedures [25-29], and burn wound
care [30,31] and in hospitalized patients [32,33].
Although several studies have investigated VR for chronic pain,
the literature to date is limited. Promising studies have used VR
to reduce pain and improve outcomes in complex regional pain
syndrome [34], chronic headache/migraine pain [35],
fibromyalgia [36,37], and chronic musculoskeletal pain [38,39].
Two recent reviews and meta-analyses reported the efficacy of
VR for physical rehabilitation from painful spinal conditions
[24] and for orthopedic rehabilitation in terms of reduced pain
and disability [40]. In such studies, the user may engage with
interactive VR alone or within the context of kinematic training.
The literature to date is limited by studies that are conducted in
experimental or clinical settings, do not compare to a non-VR
group, or include very small samples. Most importantly, the
VR studies to date are focused primarily on distraction or
physical rehabilitation and do not include pain management
education or cultivation of behavioral pain self-management
skills (eg, diaphragmatic breathing or cognition and emotion
regulation). Crucially, if found to be effectively delivered by
VR, such content could serve as either a replacement or
treatment extender for in-person behavioral medicine clinic
visits. Studies are needed to determine whether behavioral pain
management skills-based VR is effective and can facilitate
sustained pain relief through skills mastery and increased
self-efficacy for pain self-management. The VR platform could
transcend many current barriers to care and potentially provide
a scalable way to deliver on-demand home-based behavioral
treatment for chronic pain.
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Figure 1. Oculus Go virtual reality headset.
Figure 2. Image of Pain Care virtual reality content (swimming with dolphins).
Objectives
Building on the nascent literature on VR for chronic pain, we
aim to evaluate a skills-based behavioral medicine VR program
for chronic low back pain and fibromyalgia to provide
preliminary data on its utility and efficacy as a stand-alone
home-based treatment for people in the community. To
accomplish this goal, we conducted an exploratory randomized
controlled trial (RCT) with 3 main aims: (1) to determine the
feasibility and satisfaction of a self-administered, at-home,
skills-based 21-day VR intervention (pain care VR) for chronic
pain; (2) to evaluate the preliminary efficacy of VR intervention
for reducing average pain intensity and pain-related outcomes;
and (3) to isolate the immersive effects of VR by comparing it
with an audio-only treatment group. We hypothesized good
feasibility and satisfaction for VR as well as the superiority of
VR over audio treatment for pre-post improvement across the
pain indicator variables.
Methods
Design and Setting
This was a parallel-group, randomized controlled clinical trial
involving 2 home-based behavioral interventions applied in a
community-based, web-based convenience sample of people
with chronic pain conducted between March and May 2019.
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Procedures
Participants were recruited remotely through web-based
advertisements on Facebook and The Mighty, a digital health
community. Internet and computer literacy were implicit de
facto eligibility criteria. Eligibility screening involved a brief
telephone assessment for enrollment criteria outlined in the
Inclusion and Exclusion Criteria section.
Inclusion and Exclusion Criteria
Following electronic informed consent (see Multimedia
Appendix 1for the study consent form), study participants were
randomized one-to-one using a Research Electronic Data
Capture Cloud random number generator and allocated to the
treatment group. All study procedures were completed remotely,
and no in-person visits were required. Study participants were
not blinded to the treatment group assignment because of the
obvious nature of the mode of delivery of their assigned
treatment. Participants assigned to the VR group were called
by a study staff to ensure receipt of the mailed VR kit and for
a brief orientation to materials. A study staff member was
available by phone at the request of study participants in both
groups. Participant compensation was prorated based on the
number of surveys completed; they received up to US $30 in
the form of an Amazon electronic gift card following completion
of their final study survey. The study was approved by the
Western institutional review board (Puyallup, WA).
Treatment Groups
Both treatment groups received the same didactic content
delivered in distinct formats (VR versus audio; see Multimedia
Appendix 2 for program content). Treatment consisted of a
variety of sessions to support participants in learning
self-management skills based on evidence-based CBT principles
as well as biofeedback and mindfulness strategies used in pain
management. The program was designed to improve
self-regulation of cognitive, emotional, and physiological
responses to stress and pain and comprised 3 main content
categories:
Skills rooted in pain CBT: brief didactics describe how
thoughts and emotions can impact pain and techniques on
thought restructuring and adaptive regulation of pain-related
cognition and emotion (eg, addressing pain catastrophizing
tendencies).
Relaxation training: participants engage in diaphragmatic
breathing exercises to enhance parasympathetic nervous
system function and decrease physiological hyperarousal.
Importantly, relaxation training was optimized in the VR
group with visual biofeedback that displayed the
environment responding to the users’physiologic behavior
during the exercises (Figure 3). The software uses a
patent-pending algorithm to detect the user’s exhalations
with the VR headset’s built-in microphone, along with a
hardware breath amplifier that directs the user’s breath
toward the microphone. The user’s breath is then visualized
in the VR environment as either breath particles or waves
expanding outward from the user, with the synchronization
of physical exhalation and the visual effects deepening the
immersion of the experience and helping the user slow and
deepen their respiration.
Mindfulness: mindfulness content encouraged awareness
of the mind and body (somatic cues) as well as thought
release (nonattachment).
Figure 3. Image of Pain Care virtual reality content that visualizes the user’s breath.
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The 21-day program consisted of 4-8 treatment sessions from
each content category with the duration of session length ranging
from 1 to 15 min. Each treatment session was indexed as
complete if the participants initiated the experience. Participants
could replay the completed sessions.
Virtual Reality Group
VR group participants were mailed an Oculus Go VR headset
preloaded with VR software developed by AppliedVR. The
Oculus Go is an easy-to-use, stand-alone VR headset with an
accompanying orientation-tracked controller, a head-mounted
display with a high-resolution screen, built-in spatial audio
speakers, and an integrated microphone. A VR user manual sent
via email included an instructional video on the proper use of
the VR headset. Participants were instructed to telephone VR
support staff if they had any questions or difficulty in using the
headset. Participants were instructed to complete 1 VR treatment
session daily for 21 days (Multimedia Appendix 2).
Audio Group
The audio program consisted of the majority of the same
narrative content contained in the VR program, with changes
made to the descriptive titles for each session. Owing to VR
having a visual media form and audio that specifically references
the changing images in the VR environment, approximately
one-third of the VR program could not be included verbatim in
the audio. Rather, the audio session topical content was closely
matched to the corresponding VR session for that day and
adapted to eliminate any references to visual content that would
be confusing to the listener. Participants received an electronic
link to the audio recordings on SoundCloud (a music streaming
platform) where they could choose to stream or download the
audio recordings on their smartphones, laptops, or desktop
computers. Participants were instructed to complete 1 audio
treatment session daily for 21 days (Multimedia Appendix 2).
Data Collection and Variable Measurement
Data collection consisted of electronically collected
patient-reported measures and objective use data collected from
the VR devices and audio access logs.
In accordance with the Initiative on Methods, Measurement,
and Pain Assessment in Clinical Trials (IMMPACT)
recommendations, we included multiple methods to evaluate
the importance of change in outcome measures across 4
recommended domains: pain intensity, health-related quality
of life as defined by physical functioning, emotional functioning,
and ratings of overall improvement [41,42].
Data Collection Time Points
Data were collected across 4 phases of the study: screening,
pretreatment baseline, treatment, and posttreatment (day 22).
The pretreatment baseline assessment period involved 3 survey
time points: days 9, 6, and 3 (averaged to create a single
pretreatment baseline value). Surveys were distributed 7 times
during the active treatment period (days 1, 3, 6, 9, 12, 15, and
18) and posttreatment on days 21 and 22.
Measures
The Defense and Veterans Pain Rating Scale (DVPRS) [43]
was used to measure average pain intensity, and the DVPRS
interference scale was used to measure pain interference on
activity, sleep, mood, and stress over the past 24 hours [44].
Average Pain Intensity
The average pain intensity was rated for the previous 24 hours
using an 11-point numeric rating scale (0=no pain and 10=as
bad as it could be; nothing else matters). The average pain
intensity was assessed pretreatment (baseline), during treatment,
and at the end of treatment on day 21.
Pain Interference on Activity, Mood, Sleep, and Stress
Participants were asked to rate the extent to which their pain
interfered with their activity, mood, sleep, and stress over the
past 24 hours (0=does not interfere and 10=completely
interferes). Pain interference was assessed pretreatment
(baseline), during treatment, and at the end of treatment on day
21.
Pain Catastrophizing
The 13-item Pain Catastrophizing Scale (PCS) [45] is a validated
instrument widely used clinically and in pain research to assess
patterns of negative cognition and emotion in the context of
actual or anticipated pain. Despite having discrete subscales for
rumination, magnification, and feelings of helplessness related
to pain, prior work has shown that the PCS operates
unidimensionally [46]. For this study and the purpose of brevity,
the following 4 items were used: “It’s terrible and I think it’s
never going to get any better,“I become afraid that the pain
will get worse,” “I can’t seem to keep it out of my mind,” and
“I keep thinking about how badly I want the pain to stop.
Respondents rate the frequency in which they experience such
thoughts on a scale ranging from 0 (not at all) to 4 (all the time).
The items are summed to create a total score and index for pain
catastrophizing. The four-item PCS was administered on day 0
(baseline) and on day 22.
Pain Self-Efficacy
The two-item Pain Self-Efficacy Questionnaire (PSEQ-2) is a
validated instrument used to assess patients’confidence in their
ability to carry out their daily activities [47]. The scale includes
the following 2 items: “I can still accomplish most of my goals
in life, despite the pain” and “I can live a normal lifestyle,
despite the pain.” Respondents rate their responses to the items
using a 7-point scale, ranging from 0 (not at all confident) to 4
(completely confident). The two-item scores are summed to
create a total score. PSEQ-2 was administered on day 0
(baseline) and on day 22.
Patient Global Impression of Change
Aligning with IMMPACT recommendations for pain research
[48], Patient Global Impression of Change was assessed on day
22 (posttreatment survey) using the question, “Since the
beginning of the study, how has your pain changed?” on a
7-point scale, ranging from much worse to much better.
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Satisfaction With Treatment
Satisfaction with treatment was assessed on day 22
(posttreatment survey) using the question, “How satisfied or
dissatisfied are you with the ability of this VR (audio) program
to relieve your symptoms?” on a 5-point scale (1=extremely
dissatisfied to 5=extremely satisfied).
Motion Sickness and Nausea
Adverse experiences with using VR were assessed on day 22
(posttreatment survey) using the question, “Did you experience
any motion sickness or nausea while using VR?” on a 4-point
scale, with 0=never, 1=sometimes, 2=often, and 3=always. This
single-item evaluation of cybersickness was adapted from related
work on visual images and motion sickness.
Study Sample and Analytic Data Set
A convenience sample of 97 participants who met all study
criteria was enrolled, randomized, and allocated to the VR or
audio treatment groups (VR=47 and audio=50). Of 97
participants, 88 (VR=42 and audio=46) provided pretreatment
baseline values for the 5 pain indicators and moved to the
intervention phase of the study. Of the 88 participants, 74
(VR=35 and audio=39) completed at least one survey over the
21-day treatment phase. The analytic sample comprised 74
participants who completed the baseline measures and at least
one survey during the intervention phase.
Statistical Analysis
The feasibility of the VR treatment was indexed using 3 aspects
of the participants’ experience: engagement, satisfaction, and
adverse effects nausea/discomfort. For engagement,
individual-level session data exist only for the VR group; as
such, we presented a descriptive statistic of the total number of
sessions launched by the VR and audio groups. Group
differences in posttreatment satisfaction (day 22) were assessed
using a ttest. For nausea and discomfort, we provided the
proportion of participants who did not experience any
nausea/discomfort.
With regard to the secondary outcome of the efficacy of the VR
treatment on the 5 pain-related indicators (average pain intensity
and pain interference with activity, mood, sleep, and stress), we
specified a repeated measures model with time of measurement
(henceforth time) as the sole predictor. The effect of interest
was whether there was a significant improvement in the 5 pain
indicators from baseline through the end of treatment, assessed
through the significance of the main effect for time. To test the
immersive effects of VR relative to audio treatment, we analyzed
each of the 5 pain indicators in a linear mixed model framework
in which treatment (VR versus audio) was specified as a
between-participants factor and time was specified as a
within-participants factor with participant-specific intercept and
time specified as random effects. The effect of interest was
whether the improvement in the pain indicators was different
for the VR versus the audio group over time, which was assessed
through the significance of the group×time interaction.
Posttreatment effect sizes (baseline to treatment completion at
day 21) were computed by treatment group using an adaptation
of Cohen dto suit the repeated measures design [49].
The four-item PCS and two-item PSEQ scales were analyzed
in a mixed modeling framework, except that there were only 2
time points (baseline day 0 and day 22). We aimed to test 3
questions: (1) whether pain catastrophizing reduced over time
and pain self-efficacy increased over time, both assessed through
the significance of the time main effect; (2) whether the VR
versus audio group had a differential effect, assessed through
the group main effect; and (3) whether the immersive aspect of
VR produced a differential impact compared with audio over
time, assessed through a time×group interaction.
Group equivalence was assessed through univariate tests of
association between treatment groups (VR/audio) on
demographics (age, gender, race, household income, number
of children 17 in the home, employment status, and relationship
status), anhedonia, depression, and baseline levels of pain
intensity and pain-related interference to sleep, activity, stress,
and mood.
Results
Sample Characteristics
No significant differences were found between the VR and audio
groups for baseline demographic, anhedonia, and depression
variables (Table 1). Treatment groups differed in duration of
pain since onset, with the VR group having greater pain duration
as indexed by the following. Pain duration of 1 year to <5 years
represented 40% (14/35) of the VR group and 21% (8/39) of
the audio group, whereas pain duration of <1 year represented
3% (1/35) of the VR group and 21% (8/39) of the audio group
(P=.03).
Furthermore, the baseline values for average pain intensity and
pain-related interference with activity, mood, sleep, and stress
were found to be equivalent between the study groups (all P
values>.29; Multimedia Appendix 3).
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Table 1. Participant characteristics by treatment group (N=74).
Pvaluea
Virtual reality (n=35)Audio (n=39)Variable
.47Gender, n (%)
26 (74)26 (67)Male
9 (26)13 (33)Female
.63Age group (years), n (%)
3 (9)3 (8)25-34
5 (14)8 (21)35-44
11 (31)12 (31)45-54
11 (31)7 (18)55-64
5 (14)9 (23)65-74
.63Race, n (%)
6 (17)2 (5)Missing
4 (14)3 (8)African American
0 (0)2 (5)Asian
21 (72)28 (76)White
3 (10)2 (5)Hispanic/Latino
0 (0)1 (3)Multiracial/other
1 (3)1 (3)Native American/Pacific Islander
.17Education, n (%)
6 (17)2 (5)Missing
0 (0)3 (8)Some high school
14 (48)11 (30)High school graduate
4 (14)2 (5)Some college
6 (21)13 (35)Bachelor degree
5 (17)8 (22)Postgraduate
.75Employment, n (%)
6 (17)2 (5)Missing
11 (38)16 (43)Full time
9 (31)7 (19)Part time
3 (10)3 (8)Not working
1 (3)1 (3)Retired
5 (17)10 (27)Unable to work
.16Marital status, n (%)
6 (17)2 (5)Missing
15 (52)16 (43)Married/civil union
1 (3)1 (3)Widowed
5 (17)5 (14)Divorced/separated
4 (14)1 (3)Single/cohabitating
4 (14)14 (38)Single
.03Pain onset, n (%)
1 (3)8 (21)6 months to <1 year
14 (40)8 (21)1 year to <5 years
13 (37)10 (26)5 years to <10 years
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Pvaluea
Virtual reality (n=35)Audio (n=39)Variable
7 (20)13 (33)>10 years
.20Anhedonia
1.1 (0.8)1.4 (0.8)Mean (SD)
0.0-3.00.0-3.0Minimum to maximum
1.0 (1.0-2)1.0 (1.0-2)Median (IQR)
.15Depression
0.9 (0.7)1.2 (0.7)Mean (SD)
0.0-3.00.0-3.0Minimum to maximum
1.0 (0.0-1)1.0 (1.0-2)Median (IQR)
aThe Pvalues represent the parametric test of significant differences between the virtual reality and audio conditions [50].
Feasibility of At-Home Virtual Reality Interventions
for Chronic Pain
This study was designed to provide indicators for feasibility
(indexed by participant engagement, satisfaction, and adverse
effects) for an at-home self-administered 3-week VR chronic
pain treatment program. In the following section, we reported
the results for these 3 feasibility indicators.
Participant Engagement (Number of Treatment Sessions
Completed)
Participants were encouraged to follow the 21-day treatment
schedule and told they could repeat any completed experiences
at any time. In contrast to the VR group, individual-level session
launch data do not exist for the audio group, and engagement
data exist only at the group level. As such, we limited the
description to the total number of sessions launched by the
treatment group for the study period. We observed a total of
1048 and 1067 sessions launched in the audio group and the
VR group, respectively (these group-level data do not account
for discrepancy in group size). VR participants completed an
average of 34.4 sessions (SD 20.30), which exceeded the
minimum number (21 sessions) they were asked to complete.
Overall, 54 participants responded to the day 22 survey
(audio=29 and VR=25), which included items on satisfaction
with treatment and motion sickness and nausea (for the VR
group).
Treatment Satisfaction
Among participants who completed the postintervention survey
(n=54), 84% (n=21/25) of participants in the VR group and 72%
(n=21/29) of participants in the audio group were either
extremely satisfied or very satisfied.
Motion Sickness and Nausea
Of the 25 VR respondents who completed the day 22 survey,
76% (n=19/25) reported never experiencing nausea or motion
sickness. Of the 6 participants who reported nausea or motion
sickness, 5 reported experiencing the lowest possible symptom
frequency (sometimes) and 1 participant reported experiencing
it often. We tested whether motion sickness and nausea impacted
the engagement with the VR treatment by examining the number
of VR sessions launched for those with sometimes (n=5) and
often (n=1) nausea/motion sickness and the remainder of the
VR group (n=29). We found that experiencing nausea/motion
sickness at the lowest level did not negatively impact the use
of VR, as indexed by the number of sessions launched (36
sessions versus 33 sessions for the remainder of the VR group).
However, the single individual who reported nausea/motion
sickness often launched only one-third of the number of sessions
compared with the remainder of the VR group (11 sessions
versus 33 sessions).
Survey Completion
There was no group difference for completion of the 8 treatment
surveys administered during and immediately following the
21-day treatment period (VR=5.5 and audio=5.6; P=.89).
Preliminary Efficacy on Patient-Reported Outcomes
(Virtual Reality Group Only)
For the VR group, we found significant effects on each of the
5 pain indicators using the repeated measures model in which
time was the sole predictor (all P<.001). For brevity and clarity,
we included only the baseline and 21-day mean values in the
text but provided the mean values for all time points in the
figures. The average reductions from baseline through day 21
were as follows: pain intensity was reduced by 30% (mean
reduced from 4.6 to 3.2; Cohen deffect size of 0.71),
pain-related activity interference reduced by 37% (mean reduced
from 4.9 to 3.1; Cohen deffect size of 0.83), pain-related mood
interference reduced by 50.0% (mean reduced from 5.4 to 2.7;
Cohen deffect size of 0.94), pain-related sleep interference
reduced by 40.4% (mean reduced from 5.2 to 3.1; Cohen deffect
size of 0.87), and pain-related stress interference reduced by
49.1% (mean reduced from 5.3 to 2.7; Cohen deffect size of
0.89). All the aforementioned effect sizes met or exceeded the
>30% threshold for clinically important changes, and
improvement in pain-related mood interference met the
substantial clinical importance threshold of >50% [48,51].
Comparison Between the Virtual Reality and Audio
Treatment Groups
The 5 figures below (Figures 4-8) compared group effects over
time for the 5 pain indicators. For all figures, the trend of the
pain-related variable was displayed over time for participants
in the VR and audio groups. Values in the x-axis refer to the
number of days in the study, where 0represents the baseline
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computed as the average of the 3 preexposure measures on 9,
6, and 3 days before the start of the treatment.
Average Pain Intensity
Pain intensity decreased over time in both groups, and the
decline was steeper for the VR and audio groups (P=.04), with
differences becoming more pronounced from day 15 onward.
It should be noted that none of the simple effects (ie, effect of
group within time slice) are significant (Figure 4). As seen in
Multimedia Appendix 4, from baseline to day 21, consistent
with the time×group interaction, the Cohen dwas smaller in
the audio group than in the VR group (0.42 and 0.71,
respectively).
Figure 4. Effect of virtual reality vs audio on pain intensity over time.
Pain-Related Activity Interference
Activity interference decreased more steeply in the VR group
than in the audio group (P=.005), with differences becoming
more pronounced from day 15 onward (Figure 5). The simple
effect (ie, effect of group within time slice) was significant at
day 18 (VR<audio; P=.02). As seen in Multimedia Appendix
4, Cohen dwas smaller in the audio group than in the VR group
(0.26 and 0.83, respectively).
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Figure 5. Effect of virtual reality vs audio on pain-related activity interference over time.
Pain-Related Mood Interference
As shown in Figure 6, mood interference appeared to decrease
more steeply in the VR group than in the audio group. The
difference between the VR and audio groups became more
pronounced from day 15 onward. The simple effect (ie, effect
of group within time slice) was significant at day 18 (VR<audio;
P<.001). As seen in Multimedia Appendix 4, Cohen dwas
smaller in the audio group than in the VR group (0.76 and 0.94,
respectively).
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Figure 6. Effect of virtual reality vs audio on pain-related mood interference over time.
Pain-Related Sleep Interference
Reductions in sleep interference were greater in the VR group,
with the simple effects (ie, effect of group within time slice)
reaching significance at day 1 (audio<VR; P=.02) and on day
18 (VR<audio, Figure 7; P=.002).
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Figure 7. Effect of virtual reality vs audio on pain-related sleep interference over time.
As seen in Multimedia Appendix 4, Cohen dwas smaller in the
audio group than in the VR group (0.64 and 0.87, respectively).
Pain-Related Stress Interference
As shown in Figure 8, stress interference appeared to decrease
more steeply in the VR group compared with the audio group,
and this difference was more pronounced from day 15 onward.
The simple effect (ie, effect of group within time slice) was
significant on day 18 (P=.01). As seen in Multimedia Appendix
4, Cohen dwas smaller in the audio group than in the VR group
(0.87 and 0.89, respectively).
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Figure 8. Effect of virtual reality vs audio on pain-related stress interference over time.
Pain Catastrophizing
We observed a significant main effect of time, with pain
catastrophizing decreasing for both groups over time (P<.001).
The main effect for group was not significant (P=.61). Finally,
we did not perform a time×group interaction (P=.52).
Pain Self-Efficacy
We observed a significant main effect of time, with pain
self-efficacy increasing in both groups over time (P<.047). The
main effect for group was not significant (P=.68). Finally, we
did not perform a time×group interaction (P=.46).
Global Impression of Change
At day 22, among survey responders (n=54), 84% (n=21/25) of
participants in the VR group reported that their pain was
improved, 16% (n=4/25) reported no change, and 0% (n=0/25)
reported worsening pain. In the audio group, 62% (n=18/29) of
participants reported improvement, 34% (n=10/29) reported no
change, and 3% (n=1/29) reported worsening pain.
Finally, because of the observed group difference in the duration
of chronic pain (indexed as pain onset in Table 1), we conducted
additional analyses with pain onset specified as a covariate in
the model with time, group, and time×group as predictors of
the 5 pain variables. The significance of the time main effect
and time×group interaction effects was fully preserved. When
intention-to-treat (ITT) analyses were applied all of the results
were preserved with one exception; the time×treatment
interaction was no longer significant.
Discussion
Principal Findings
We conducted an unblinded randomized controlled study in a
web-based convenience sample of community-based participants
with nonmalignant chronic low back pain and/or fibromyalgia
by comparing at-home self-administered VR treatment with an
audio-only treatment group (same audio content as VR with
minor modifications made for one-third of the modules). The
primary goal of the study was to evaluate the feasibility of a
self-administered home-based VR program for chronic pain
that included skills-based content informed by evidence-based
CBT for chronic pain. The secondary goal was to conduct an
RCT of the VR treatment to an audio-only treatment. We aimed
to determine the preliminary efficacy of VR for reducing average
pain intensity and pain-related interference with activity, mood,
sleep, and stress over the 21-day treatment program. Our tertiary
goal was to isolate the immersive effects of the skills-based VR
program by comparing the effects between treatment groups.
VR demonstrated good feasibility as indexed by excellent
participant engagement (average of 34 sessions completed over
the 21-day treatment program), high ratings for satisfaction with
the treatment (84%), and relatively low reporting for motion
sickness and nausea (n=6/25, 24% of VR participants who
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completed the day 22 survey). Of these 6 participants, 5 reported
the lowest level of symptom frequency possible (sometimes).
We found that this symptom level did not interfere with VR
treatment engagement, as indexed by the number of sessions
launched compared with participants in the remainder of the
VR group. The single individual who experienced nausea and
motion sickness often showed markedly decreased use of VR
(11 sessions launched versus 34 for people with low nausea and
the remainder of the VR group).
With respect to preliminary efficacy, VR demonstrated the
significant reduction in average pain intensity and pain-related
interference in activity, mood, sleep, and stress over the course
of the 21-day treatment program. Treatment effect sizes
suggested that a home-based stand-alone, digital, skills-based
treatment program may affect clinically meaningful changes in
patient-reported pain and pain correlates. The durability of the
treatment effects reported here remains a topic for future
research.
Although a significant body of research exists on the use of VR
for acute pain management [26,28,30,52-54] and for physical
rehabilitation [24,40], the use of VR as a platform to deliver
behavioral medicine for chronic pain remains novel and
understudied. Research on VR for acute pain is based on the
premise that distraction is a primary mechanism of VR analgesia
[33,55]. Therefore, the effects of distraction on pain are typically
measured within a rapid time frame using study designs that
align with drug trials. Investigations of VR for chronic pain
require a different approach to align with the goal of sustained
pain management. Although VR for physical rehabilitation
shows sustained results, content is typically constrained to
rehabilitative movement, exercise, and kinematic training
[24,40] and is devoid of didactics and skills training contained
in evidence-based behavioral medicine treatments [7].
Unlike distraction alone, behavioral health therapies rarely
produce instantaneous results. Rather, skills acquisition and
mastery require time, in part because of the multisession delivery
of content, and become effective over the course of weeks, as
the content is delivered more comprehensively, and patients
practice skills during and between sessions and is correlated
with patient engagement [56]. Our prior work suggests that an
ultrabrief skill-based intervention for chronic pain evidenced
clinically meaningful improvements in pain-related symptoms
at 2 weeks, with even greater improvements evidenced at 4
weeks [12]. The results presented here dovetail with this
literature and our fundamental understanding of how didactic
and skills-based behavioral medicine treatment results accrue
over time as participants receiving increasing amounts of
knowledge and skills practice during active treatment [6,56,57].
In this study, the emergence of a more pronounced improvement
in pain outcomes at day 15 supports the hypothesis that the
didactic and skills-based elements of immersive behavioral
medicine VR are operating as expected, although confirmatory
studies are needed.
In evaluating the method of delivery of a skills-based treatment
program, this study demonstrated superior reduction of most
pain indicators in the VR group relative to the audio group after
2 weeks. Treatment group differences remained minimal until
day 12, with VR superiority strengthening from day 15 onward
and peaking on day 18. For the pain interference outcomes, the
VR group showed greater improvement compared with the
audio group. The exceptions were pain catastrophizing and pain
self-efficacy, which improved for both treatment groups. We
have no evidence that VR’s superior treatment effects were
explained by user engagement, as we observed similar rates of
engagement for both groups. Our study design allowed us to
isolate the immersive effect of VR relative to active treatment
delivered via audio format only. On balance, our findings
suggest that the treatment effect sizes for VR are both
statistically significant and clinically meaningful for pain
intensity and across the pain interference variables and are
superior to the same treatment delivered by audio alone. A key
aspect of the immersive VR experience involves dynamic
interaction between the user’s breath and the environment,
wherein voice-over coaching directs the user to slow the breath
to engage a parasympathetic response. The environment
responds to the breath, provides visual feedback to the user, and
possibly affords users enhanced acquisition of this skill relative
to the audio-only content.
Strengths and Limitations
The strengths and limitations of our study bear careful attention.
The interpretation of study findings is limited by the 2 pain
conditions studied and the selection bias inherent in the
web-based convenience sample. In addition, the analytic data
set included only those participants who completed at least one
study survey; accordingly, larger studies are needed to confirm
the findings reported here and to determine generalizability.
Medication use was not assessed and may have been a
confounding variable. Chronic pain type and duration were
self-reported, and there was no review of medical records to
confirm diagnoses. Our ability to assess VR satisfaction and
nausea/motion sickness was limited by only 25 of 35 participants
completing the day 22 posttreatment survey. Although only
17% of the full VR sample reported experiencing cybersickness
to any degree, we cannot rule out the possibility that early
attrition may be partially attributable to these adverse effects,
although notably, we did not find disparate attrition rates
between the VR and audio groups. Commercially available VR
programs typically offer a money-back guarantee trial period
to allow customers to return their VR device for refund in cases
of cybersickness. Although assignment to treatment group was
random, differences in duration of pain since onset between the
2 treatment groups may have influenced pain outcomes during
the course of the study, and we note that this difference favored
the audio group. In addition, the analysis did not focus on the
correlation between individual-level variations in the use of the
intervention (VR or audio) and the pain indicators, and this
remains a topic for future study.
Our study design merits consideration within the context of our
findings. The audio treatment group was an active comparator
with two-thirds of the audio content identical to the audio of
the VR group, and one-third of the audio content closely
matched the VR content for topical content, skills, and
experience (minus the visual and interactive elements). This
study was rigorously designed to isolate the immersive effects
of VR rather than simply comparing VR with placebo or with
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a weaker control group such as usual care. In studying a
treatment delivered 2 ways, our results suggest that the
immersive (3D visual elements, dynamic scenery, and
360-degree vision capability) and user interactivity with the
environment are pleasing, engaging, and generally effective for
those who do not experience cybersickness (many commercial
VR companies offer consumers a trial period or money-back
guarantee for cases of cybersickness).
Finally, the cost-effectiveness of VR for chronic pain relative
to in-person behavioral medicine visits or other digital treatment
options merits investigation. In-person behavioral medicine
treatments require multiple clinic visits, travel costs, time from
work and other obligations, and treatment copayment costs that
may total several hundreds of dollars over a standard 8-session
treatment package. Future research should compare home-based
VR to in-person multisession CBT for chronic pain in terms of
efficacy and cost-effectiveness. Although some 2D digital
treatment options, such as web-based pain CBT or
self-management programs, and may be sourced at no cost,
engagement rates remain relatively low. Future research may
explore participants’ perceived comparative value of VR to
audio-only treatment. VR provides patients and clinicians with
a new home-based treatment option that may be preferred by
some patients and also provide more effective pain management
to a subset of individuals. Additional studies of longer duration
may investigate the durability of treatment effects reported here.
Conclusions
This study is one of the first to explore how a self-administered
home-based VR program rooted in behavioral medicine skills
and techniques impacts chronic pain. The findings broadly
suggest that VR holds promise as effective, stand-alone,
home-based digital behavioral medicine for chronic pain.
Additional studies are needed, including larger sample sizes,
diverse chronic pain conditions, longer duration of study to best
characterize the efficacy of VR in chronic pain management,
and the impact of VR on other factors such as pain medication
use and medical care utilization. Future studies may further
elucidate the VR mechanisms of action and VR’s role in
expanding access to multimodal behavioral medicine for chronic
pain.
Acknowledgments
This study was financially supported by AppliedVR.
Conflicts of Interest
BD is employed as a chief scientific adviser to AppliedVR. PK serves as a consultant for AppliedVR.
Multimedia Appendix 1
Participant consent form.
[DOC File , 84 KB-Multimedia Appendix 1]
Multimedia Appendix 2
Schedule of 21-day virtual reality and audio programs.
[DOCX File , 14 KB-Multimedia Appendix 2]
Multimedia Appendix 3
Baseline pain-related variables by treatment group.
[DOCX File , 17 KB-Multimedia Appendix 3]
Multimedia Appendix 4
Effect sizes for change from baseline to day 21.
[DOCX File , 18 KB-Multimedia Appendix 4]
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Abbreviations
CBT: cognitive behavioral therapy
DVPRS: Defense and Veterans Pain Rating Scale
IMMPACT: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials
PCS: Pain Catastrophizing Scale
PSEQ-2: two-item Pain Self-Efficacy Questionnaire
RCT: randomized controlled trial
VR: virtual reality
Edited by P Santana-Mancilla; submitted 03.12.19; peer-reviewed by M Linnett, A Parks, D Ahern PhD; comments to author 15.01.20;
revised version received 12.04.20; accepted 05.05.20; published 07.07.20
Please cite as:
Darnall BD, Krishnamurthy P, Tsuei J, Minor JD
Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: Randomized Controlled Pilot Study
JMIR Form Res 2020;4(7):e17293
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(http://formative.jmir.org), 07.07.2020. This is an open-access article distributed under the terms of the Creative Commons
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... Virtual reality (VR) is increasingly being studied as a method to help chronic pain patients with a variety of diagnoses. Integration of rehabilitation strategies with VR, including more efficient graded exposure exercises, has been shown to reduce pain intensity and/or pain-related disability [52][53][54][55][56][57]. Some studies showed maintenance of pain during graded exercise programs, which is still significant for quality of life and ability to complete treatment options [58,59]. ...
... VR should be used in combination with traditional therapies and with attention to pain etiology for optimized analgesic effect [53,57,62,68]. Cerritelli et al. found that the combination of manual therapies allowed for a more comprehensive approach that engaged parasympathetic tone and tactile movement to enhance the visual and auditory aspects of VR [62]. This alternative, non-invasive treatment offers potential success for pain relief and improved quality of life with little side effect for patients with centralized pain. ...
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... BF-based VR (VR-BF) opens the possibility for patients to experience the therapeutic benefits of BF while avoiding the challenges associated with traditional mind-body therapies. 37 64 72 73 We have designed a randomised, blinded clinical trial to assess the feasibility and acceptability of a perioperative VR-BF intervention to reduce pain, anxiety and opioid consumption in children and adolescents undergoing surgery anticipated to cause moderate to severe pain. We hypothesise that the use of VR-BF in this population is both feasible and acceptable. ...
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... In these complex setups, sEMG sensors are increasingly being used in conjunction with accelerometers or force platforms . When comparing efficiency in different activities, there are still virtual reality solutions that focus on user experience and pain scale evaluation (Ortegon-Sarmiento et al. 2020;Trujillo et al. 2020;Darnall et al. 2020). Other indirect metrics are also assessed over time, including activity, stress, mood, and sleep (Garcia et al. 2021). ...
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Objective: This study aims to assess the feasibility of digital perioperative behavioral pain medicine intervention in breast cancer surgery and evaluate its impact on pain catastrophizing, pain, and opioid cessation after surgery. Design and setting: A randomized controlled clinical trial was conducted at Stanford University (Palo Alto, CA, USA) comparing a digital behavioral pain medicine intervention ("My Surgical Success" [MSS]) with digital general health education (HE). Participants: A convenience sample of 127 participants were randomized to treatment group. The analytic sample was 68 patients (N = 36 MSS, N = 32 HE). Main outcomes: The primary outcome was feasibility and acceptability of a digital behavioral pain medicine intervention (80% threshold for acceptability items). Secondary outcomes were pain catastrophizing, past seven-day average pain intensity, and time to opioid cessation after surgery for patients who initiated opioid use. Results: The attrition rate for MSS intervention (44%) was notably higher than for HE controls (18%), but it was lower than typical attrition rates for e-health interventions (60-80%). Despite greater attrition for MSS, feasibility was demonstrated for the 56% of MSS engagers, and the 80% threshold for acceptability was met. We observed a floor effect for baseline pain catastrophizing, and no significant group differences were found for postsurgical pain catastrophizing or pain intensity. MSS was associated with 86% increased odds of opioid cessation within the 12-week study period relative to HE controls (hazard ratio = 1.86, 95% confidence interval = 1.12-3.10, P = 0.016). Conclusions: Fifty-six percent of patients assigned to MSS engaged with the online platform and reported high satisfaction. MSS was associated with significantly accelerated opioid cessation after surgery (five-day difference) with no difference in pain report relative to controls. Perioperative digital behavioral pain medicine may be a low-cost, accessible adjunct that could promote opioid cessation after breast cancer surgery.
Article
Background Virtual reality (VR) technologies have been shown to be beneficial in various areas of healthcare; to date, there are no systematic reviews examining the effectiveness of VR technology for the treatment of spinal pain. Purpose To investigate the effectiveness of VR technology in the management of individuals with acute, subacute, and chronic spinal pain. Methods Six electronic databases were searched until November 2019. Randomized controlled trials (RCTs) assessing the effectiveness of VR were eligible for inclusion. Two independent reviewers extracted the data, assessed the risk of bias for each study and the overall quality of evidence. Mean differences of outcomes were pooled as appropriate using random‐effects models. Results Seven RCTs of high risk of bias met review criteria. Quality of evidence ranged from very low to low quality. In patients with chronic neck pain, VR improved GPE, satisfaction, and general health at short‐term follow‐up and general health and balance at intermediate‐term follow up compared to kinematic training. VR improved pain intensity and disability at short‐term and long‐term follow‐up compared to conventional proprioceptive training in patients with chronic neck pain. In patients with either subacute or chronic low back pain (LBP), VR improved pain, disability, and fear of movement compared to lumbar stabilization exercises and pain compared to conventional physical therapy (at short‐term follow‐up). In patients with chronic LBP, VR improved pain compared to lumbar stabilization exercises and fear of movement compared to conventional physical therapy (at short‐term follow‐up). Conclusion VR's potential for improvement in outcomes for spinal pain that demonstrated statistical and/or clinical significance (pain intensity, disability, fear of movement, GPE, patient satisfaction, general health status, and balance) highlights the need for more focused, higher‐quality research on efficacy and effectiveness of VR for treatment of patients with spinal pain.
Article
Background Post-operative pain control and narcotic over-utilization are challenging issues for surgeons in all fields. While virtual reality (VR) has been increasingly applied in various fields, its feasibility and efficacy in the peri-operative period has not been evaluated. The aim of this study was to examine the experience of an integrated VR protocol in the perioperative setting. Methods Patients undergoing minimally invasive foregut surgery at a single institution were randomized to receive a series of VR meditation/mindfulness sessions (VR) or to standard care after surgery (non-VR). Post-operative pain levels, narcotic utilization and patient satisfaction were tracked. Results Fifty-two patients were enrolled with 26 in each arm. Post-operative pain scores, total narcotic utilization, and overall satisfaction scores were not significantly different between the two groups. For patients in the VR arm, sessions were able to be incorporated into the perioperative routine with little disruption. Most (73.9%) were able complete all six VR sessions and reported low pain, anxiety, and nausea scores while using the device. A high proportion responded that they would use VR again (76.2%) or would like a VR program designed for pain (62.0%). There were no complications from device usage. Conclusion VR is a safe and simple intervention that is associated with high patient satisfaction and is feasible to implement in the perioperative setting. While the current study is underpowered to detect difference in narcotic utilization, this device holds promise as an adjuvant tool in multimodal pain and anxiety control in the peri-operative period.
Article
Context: Some patients with cancer are able to complete psychosocial pain management intervention sessions and others find it difficult to do so. Objectives: Conduct a secondary analysis of a randomized clinical trial (N=178) that compared delivery formats (in-person vs. videoconference) of a Pain Coping Skills Training (PCST) intervention for patients with cancer to: 1) examine if intervention session completion predicts post-intervention outcomes of pain severity and interference, psychological distress, physical well-being, and pain self-efficacy; and 2) identify predictors (i.e., demographics, medical characteristics, baseline outcome scores) of session completion METHODS: Session completion (i.e., completing all four sessions vs. missing at least one session) was tested as a predictor of post-intervention outcomes. Predictors of session completion were then examined. Results: In both study conditions combined, PCST session completion predicted improvement from baseline to post-intervention in pain severity (β=-0.27, p=0.03), pain interference (β=-0.25, p=0.048), and pain self-efficacy (β=0.23, p=0.07). Participants in the videoconference condition were significantly more likely than those in the in-person condition to complete all sessions (83% vs. 65%, p=0.006). Participants with at least some college education (OR=4.36, p=0.04), a diagnosis of breast cancer (OR=6.73, p=0.04), and higher levels of pain self-efficacy (OR=2.32, p=0.02) were more likely to complete videoconference sessions. Participants who lived closer to the medical center (OR=0.64, p=0.07), had early stage cancer (OR=3.82, p=0.07), and fewer medical comorbidities (OR=0.59, p=0.04) were more likely to complete in-person sessions. Conclusion: Completing PCST sessions is important for improving pain outcomes. Efforts to increase session completion (e.g., videoconference delivery) should be considered.
Article
Purpose: The study aimed to determine the effect of two different distractions on pain perceptions and anxiety during venipuncture in children. Design: A randomized controlled study. Methods: A total of 139 children aged between 4 and 10 years were included in the study: 46 of them in virtual reality goggle group and 43 in the control group. An information form, the Children's Anxiety Scale, Visual Analogue Scale, and Wong-Baker Faces Pain Scale were used in the collection of data. Findings: Pain and anxiety scores were significantly lower in the virtual reality goggle and kaleidoscope group than in the control group (P < .000). Conclusions: The use of virtual reality goggle and kaleidoscope methods during venipuncture are effective in reducing children's perception of pain and anxiety. The most effective method of reducing perception of pain and anxiety is using the virtual reality goggle.
Article
Introduction: Abdominal pain is common and is associated with high disease burden and health care costs in pediatric acute recurrent and chronic pancreatitis (ARP/CP). Despite the strong central component of pain in ARP/CP and the efficacy of psychological therapies for other centralized pain syndromes, no studies have evaluated psychological pain interventions in children with ARP/CP. The current trial seeks to 1) evaluate the efficacy of a psychological pain intervention for pediatric ARP/CP, and 2) examine baseline patient-specific genetic, clinical, and psychosocial characteristics that may predict or moderate treatment response. Methods: This single-blinded randomized placebo-controlled multicenter trial aims to enroll 260 youth (ages 10-18) with ARP/CP and their parents from twenty-one INSPPIRE (INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers. Participants will be randomly assigned to either a web-based cognitive behavioral pain management intervention (Web-based Management of Adolescent Pain Chronic Pancreatitis; WebMAP; N = 130) or to a web-based pain education program (WebED; N = 130). Assessments will be completed at baseline (T1), immediately after completion of the intervention (T2) and at 6 months post-intervention (T3). The primary study outcome is abdominal pain severity. Secondary outcomes include pain-related disability, pain interference, health-related quality of life, emotional distress, impact of pain, opioid use, and healthcare utilization. Conclusions: This is the first clinical trial to evaluate the efficacy of a psychological pain intervention for children with CP for reduction of abdominal pain and improvement of health-related quality of life. Findings will inform delivery of web-based pain management and potentially identify patient-specific biological and psychosocial factors associated with favorable response to therapy. Clinical Trial Registration #: NCT03707431.
Article
Background: Virtual reality (VR) is an interactive technology that allows customized treatment and may help in delivering effective patient-centered rehabilitation. Purpose: The purpose of this review was to systematically review and critically appraise the controlled clinical trials that investigated VR effectiveness in orthopedic rehabilitation. Data sources: Pubmed, CINAHL, Embase, PEDro, REHABDATA, and Sage publications were searched up to September 2018. In addition, manual searching and snowballing using Scopus and Web of Science were done. Study selection: Two reviewers screened studies for eligibility first by title and abstract and then full text. Data extraction: Articles were categorized into general or region-specific (upper limbs, lower limbs, and spine) orthopedic disorders. Studies' quality was assessed using the Evaluation Guidelines for Rating the Quality of an Intervention Study scoring. Meta-analysis quantified VR effectiveness, compared to no-treatment, in back pain. Data synthesis: Nineteen studies were included in the quality assessment. The majority of the studies were of moderate quality. Fourteen studies showed that VR was not different when compared to exercises. Compared with the no-treatment control, 5 studies favored VR while 3 other studies showed no differences. For low back pain, the meta-analysis revealed no significant difference between VR and no-treatment control (n = 116; SMD = -0.21; 95% CI = -0.58 to 0.15). Limitations: Limitations included heterogeneity in interventions and the outcome measures of reviewed studies. Only articles in English were included. Conclusion: The evidence of VR effectiveness is promising in chronic neck pain and shoulder impingement syndrome. VR and exercises have similar effects in rheumatoid arthritis, knee arthritis, ankle instability, and post-anterior cruciate reconstruction. For fibromyalgia and back pain, as well as after knee arthroplasty, the evidence of VR effectiveness compared to exercise is absent or inconclusive.
Article
Objective Behavioral cancer pain interventions are efficacious for improving important pain outcomes; yet, traditional in‐person delivery limits patient access. This study compared videoconference‐delivered Pain Coping Skills Training (mPCST) to in‐person Pain Coping Skills Training (PCST‐traditional). Methods This study was a randomized, noninferiority trial with cancer patients. Participants (N=178) were randomly assigned to four, 45‐minute sessions of mPCST or PCST‐traditional. Session content focused on evidence‐based cognitive and behavioral pain management skills. Assessments were completed at baseline, post‐treatment, and 3‐months post‐treatment, and included measures of primary intervention outcomes (i.e., pain severity and pain interference) and secondary intervention outcomes (i.e., physical symptoms, psychological distress, physical well‐being, and self‐efficacy). The main study aim tested whether mPCST was more accessible (defined as feasibility, acceptability, patient burden, and engagement) than PCST‐traditional. The second aim tested whether mPCST was noninferior to PCST‐traditional. Results mPCST demonstrated significantly greater feasibility (i.e., attrition, adherence, time to completion) than PCST‐traditional. Both groups reported similar patient burden and engagement as well as a high degree of acceptability. All intervention outcomes demonstrated noninferiority at post‐treatment and, with the exception of physical symptoms, 3 months post‐treatment. Concerning the primary intervention outcomes, 95% CIs for the mean differences (d) were below the noninferiority margin of 1 for pain severity (post‐treatment d=0.09, 95% CI ‐0.63 to 0.81; 3 month d=‐0.43 95% CI ‐1.22 to 0.36) and pain interference (post‐treatment d=‐0.11, 95% CI ‐0.99 to 0.76; 3 month d=‐0.26 95% CI ‐1.14 to 0.62). Conclusion mPCST is highly accessible and noninferior to PCST‐traditional.