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Evaluating the Safety and Effectiveness of the Weighted Blanket With Adults During an Inpatient Mental Health Hospitalization

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The weighted blanket (WB) is a modality used to self-comfort, rest, sleep, and decrease anxiety. This exploratory, pilot study investigates the safety and effectiveness of the standardized use of the 30-pound WB with 30 adults during an acute inpatient mental health hospitalization. Safety measures include blood pressure, pulse rate, and pulse oximetry monitoring, with and without the 30-pound WB. The State Trait Anxiety Inventory-10 (STAI-10), a self-rating 0–10 anxiety scale, and electrodermal activity (EDA) readings measure effectiveness for anxiety reduction. No statistical differences in vital signs indicate WB safety. The STAI-10 and self-ratings indicate 60% had a significant reduction in anxiety using the WB. EDA readings were inconclusive.
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Occupational Therapy in Mental Health
ISSN: 0164-212X (Print) 1541-3101 (Online) Journal homepage: http://www.tandfonline.com/loi/womh20
Evaluating the Safety and Effectiveness of the
Weighted Blanket With Adults During an Inpatient
Mental Health Hospitalization
Tina Champagne, Brian Mullen, Debra Dickson & Sundar Krishnamurty
To cite this article: Tina Champagne, Brian Mullen, Debra Dickson & Sundar Krishnamurty
(2015) Evaluating the Safety and Effectiveness of the Weighted Blanket With Adults During an
Inpatient Mental Health Hospitalization, Occupational Therapy in Mental Health, 31:3, 211-233,
DOI: 10.1080/0164212X.2015.1066220
To link to this article: http://dx.doi.org/10.1080/0164212X.2015.1066220
Published online: 18 Sep 2015.
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Evaluating the Safety and Effectiveness of the
Weighted Blanket With Adults During an
Inpatient Mental Health Hospitalization
TINA CHAMPAGNE
Northampton Center for Children and Families, Northampton, Massachusetts
BRIAN MULLEN
Therapeutic Systems, Boston, Massachusetts
DEBRA DICKSON
Vidant Medical Center, Greenville, North Carolina
SUNDAR KRISHNAMURTY
University of Massachusetts–Amherst, Amherst, Massachusetts
The weighted blanket (WB) is a modality used to self-comfort,
rest, sleep, and decrease anxiety. This exploratory, pilot study inves-
tigates the safety and effectiveness of the standardized use of the
30-pound WB with 30 adults during an acute inpatient mental
health hospitalization. Safety measures include blood pressure,
pulse rate, and pulse oximetry monitoring, with and without the
30-pound WB. The State Trait Anxiety Inventory-10 (STAI-10), a
self-rating 0–10 anxiety scale, and electrodermal activity (EDA)
readings measure effectiveness for anxiety reduction. No statistical
differences in vital signs indicate WB safety. The STAI-10 and
self-ratings indicate 60%had a significant reduction in anxiety
using the WB. EDA readings were inconclusive.
KEYWORDS anxiety, autonomic nervous system, deep pressure,
touch, weighted blanket
Address correspondence to Tina Champagne, OTD, OTR/L, Cutchins Programs for
Children and Families, 77 Pleasant Street, Holyoke, MA 01040. E-mail: tina@ot-innovations.com
Color versions of one or more of the figures in the article can be found online at www.
tandfonline.com/womh.
Occupational Therapy in Mental Health, 31:211–233, 2015
Copyright #Taylor & Francis Group, LLC
ISSN: 0164-212X print=1541-3101 online
DOI: 10.1080/0164212X.2015.1066220
211
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BACKGROUND
A weighted blanket (WB) is a therapeutic modality that is used to
self-comfort, rest and to reduce anxiety or stress (Champagne, 2010,2011).
The therapeutic use of WBs was first initiated by occupational therapists
employing a sensory-based approach, among people with learning and per-
vasive developmental disabilities (Ayres, 1979; Roley, 2009). More recently,
the WB has become increasingly utilized with consumers of mental health
services to expand upon the existing humane and therapeutic interventions
(Champagne & Stromberg, 2004). This trend parallels the trauma informed
care and recovery models, and the mission of the President’s New Freedom
Commission, toward increasing the holistic therapeutic options available
to people with a mental illness (U. S. Department of Health and Human
Services, 2003a,2003b).
The National Association for State Mental Health Program Directors
(NASMHPD) also promotes the integration of interventions that are sensory
supportive, humane, and trauma-informed across mental health care service
delivery (NASMHPD, Medical Directors Council, 1999; National Executive
Training Institute [NETI], 2003). Consequently, the skilled use of weighted
modalities is being endorsed as part of the national trauma-informed care,
seclusion and restraint reduction, and recovery initiatives, as tools that may
be used for prevention and crisis intervention purposes (NASMHPD, NETI).
Research is limited, however, on the safety and effectiveness of WBs.
From a neurophysiological perspective, sensory processing is one of the
purported mechanisms supporting the effectiveness of the WB. Since there is
limited literature available on the use of WBs and proposed mechanisms
of effectiveness, a review of sensory processing as it has been applied to
the use of weighted modalities will be reviewed. According to Miller and
Lane (2000),
Sensory processing is an encompassing term that refers to the way in
which the CNS and the peripheral nervous system manage incoming
sensory information from the seven peripheral sensory systems. The
reception, modulation, and integration of sensory stimuli, including the
behavioral responses to sensory input, are all components of sensory
processing (p. 1).
Sensory modulation is a component of sensory processing (Miller &
Lane, 2000). Miller, Reisman, McIntosh, and Simon (2001) define sensory
modulation as,
the capacity to regulate and organize the degree, intensity, and nature of
responses to sensory input in a graded and adaptive manner. This allows
the individual to achieve and maintain an optimal range of performance
and to adapt to challenges in daily life (p. 57).
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Sensory modulation interventions are non-invasive, self-directed
therapeutic interventions (activities and modalities), offering specific amounts
and types of sensory input for the purposes of fostering organization and
self-regulation. More recently, sensory modulation interventions are increas-
ingly offered to people experiencing a variety of mental health symptoms
(Champagne, 2003,2005,2006,2010,2011). According to Hanschu (1998),
attention must be paid to the type and amount of sensorimotor input, pro-
vided at strategic times, in order to significantly influence alertness, arousal,
attention, and an individual’s ability to adapt and participate in meaningful life
activities. In this way, sensory modulation interventions such as WBs are used
to assist individuals in achieving and maintaining an optimal level of nervous
system arousal to help support self-regulation and participation in meaningful
roles and occupations.
Deep Pressure Touch Stimulation
WBs are a class of sensory processing-related interventions that utilize deep
pressure touch simulation (DPTS). Sensory modulation interventions offering
DPTS involve the application of a tactile stimulus, providing the feeling of firm
pressure, similar to that experienced from a hug, holding, swaddling, or mass-
age (Grandin, 1992). Anecdotal accounts support the hypothesis that when
used in an individualized manner, the WB appears to facilitate the ability to
feel safe, comforted, and grounded in the world (Champagne, 2010,2011;
Champagne & Stromberg, 2004). Therapists use modalities and activities
affording DPTS with clients for the purpose of achieving specific functional,
occupational goals. DPTS can be provided through human application
(squeezing a person or brushing), or the use of weighted modalities (e.g.,
WBs, vests, or wraps), elastic garments (e.g., pressure vest), inflatable devices
(e.g., inflation vest), or other therapeutic equipment (e.g., squeeze machine,
brushing techniques).
Despite the increased use of modalities providing DPTS in occupational
therapy practice, and the many different types of weighted and pressure mod-
alities available today, a clear understanding of the safety and the therapeutic
effects among varied client populations and age ranges is lacking. Currently,
the literature availableon the safety and effectiveness of the use of DPTS afford-
ing modalities primarily focuses on weighted vests, pneumatic=pressurized
devices or garments used with varied populations. There is only one research
study currently published on the safety and effectiveness of WBs with adults
(Mullen, Champagne, Krishnamurty, Dickson, & Gao, 2008). Thus, existing evi-
dence on DPTS as a therapeutic intervention is primarily with DPTS modalities
other than the WB, and with populations other than the adults with mental
health-related therapeutic needs and goals.
Although the use of deep touch pressure is not yet considered an
evidence-based practice (Morrison, 2007), the lack of evidence does not
Safety and Effectiveness of the Weighted Blanket 213
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necessarily exclude the use of interventions affording DPTS as an effective
therapy. Rather, research is needed to continue to further develop the
evidence-base, which will ultimately support caregivers and clients when
making treatment decisions. Given the potential of the WB as a humane, sen-
sory, and recovery supportive treatment option, it is necessary to continue
studying the safety and effectiveness variables involved in the use of WBs
among varied client populations.
Existing research on other DPTS affording modalities (e.g., weighted
vests, inflation vests, WBs) supports the anecdotal reports of the effectiveness
of WBs with adult consumers of mental health services. For instance, research
on weighted and inflation vests demonstrates that skilled use can result in
changes in autonomic arousal, a decrease in impulsivity, an increase in atten-
tion and the ability to focus on fine motor tasks, and a decrease in self-
stimulatory behaviors in children with pervasive developmental and attention
disorders (Fertel-Daly, Bedell, & Hinojosa, 2001; Lin, Lee, Chang, & Hong,
2014; Olson & Moulton, 2004a,2004b; Reynolds, Lane, & Mullen, 2015;
VandenBerg, 2001). Additionally, Smith, Press, Koenig, and Kinnealey
(2005) showed that 95%of children with ADHD benefited from using sensory
modulation-related interventions, including those providing DPTS, along with
taking medications. Krauss (1987) examined the influence of DPTS among
college students who used a self-controlled mechanical device to self-
administer DPTS with a pulley system, by administering qualitative surveys
and measuring body temperature to measure anxiety. Although the results
of Krauss’s study were inconclusive, this study demonstrates the value of the
use of psychophysiological and self-report measures when researching the
influence of DPTS (Edelson, Edelson, Kerr, & Grandin, 1999; Krauss, 1987).
Edelson et al. (1999) used electrodermal activity (EDA) and the Connors
Parent Rating Scale to explore the influence of Grandin’s Squeeze Machine
on the anxiety levels of children with autism. Although only a marginal
reduction in physiological anxiety was observed, a significant decrease in
tension (a behavioral measure of anxiety) occurred. The researchers con-
cluded that ‘‘deep pressure appears beneficial for children with high levels
of anxiety or arousal, and there may be a threshold of anxiety or arousal
required for deep pressure to be beneficial’’ (Edelson et al.). One must
approach many of the existing studies with some caution because several
use small sample sizes and there are some inconsistencies in the amount,
type, and length of time DPTS is used, which may influence study results.
Two recent studies on the use of vests affording DTPS used larger sample
sizes, each showing positive results with children (Lin et al., 2014) and adults
(Reynolds et al., 2015).
WBs are currently being used with children and adults with mental health
diagnoses without a basis for understanding whether or not WBs are safe to
use (physiologically). Furthermore, given the dynamic nature of human
systems, there are many possible reasons why the WB may be perceived by
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clients or therapists as effective or ineffective. This study seeks to begin to
explore initial WB safety and effectiveness outcomes with adults admitted
to an acute inpatient psychiatric hospital setting. Due to the complex relation-
ship between neurophysiological and psychological functioning, knowledge
from the fields of neuroscience, neuro-occupation, and trauma-informed care
is reviewed.
Neurophysiological Mechanisms Supporting Effectiveness
One of the purported mechanisms explaining the effectiveness of WBs
involves the influence on the autonomic nervous system. The sympathetic
nervous system (SNS), influences an increase in anxiety, tension and the
‘‘fight-or-flight’’ response, and the parasympathetic nervous system (PNS)
influences the ‘‘rest and digest’’ and polyvagal responses (Boucsein, 1992;
Porges, 1992). Interventions affording DPTS are often recommended by occu-
pational therapists to influence a dampening of the SNS response (often
perceived as increased arousal and=or anxiety), for the purposes of enhanc-
ing adaptation, emotion regulation, occupational performance, and partici-
pation (Edelson et al., 1999; Fertel-Daly et al., 2001; Grandin, 1992; Mullen
et al., 2008; Reynolds et al., 2015; VandenBerg, 2001). DPTS is carried by
the dorsal column system to higher levels through the reticular formation
(RF), thalamus and the sensory processing areas of the parietal lobe (Vanden-
Berg, 2001). Royeen and Lane stated, ‘‘Since the RF mediates arousal, the
reticular projections of the dorsal column pathway may be related to the
efficacy of these inputs in decreasing arousal and producing calming’’
(1991, p. 115). Therapeutic activities and modalities affording DPTS also send
information to the Purkinje cells in the cerebellum, which can influence a
dampening of stimulation coming into the RF through neurotransmitters or
other avenues of brain chemistry (Vandenberg, 2001).
Studying the PNS more closely, Porges (1992) expanded upon the
understanding of the dynamic and significant role of the vagus nerve as a
central contributor to the parasympathetic system. The vagus nerve inner-
vatesmanyofthemusclessupporting the ability to listen, communicate,
and self-regulate (social engagement system). When an individual is fearful,
one’s vagal tone may increase, influence, and increase in the PNS response.
Thus, Porges’ work emphasizes that unless an individual feels safe and
secure, it is neurophysiologically difficult to communicate and function
(e.g., emotionally, cognitively, socially, academically, vocationally). Polyva-
gal theory helps to substantiate why it is critical to help people to feel safe
and secure, in order to foster the ability to participate in meaningful life
roles and activities. Such neurophysiological findings help to support
the need to create and offer more nurturing types of sensory, trauma
informed, and recovery-focused interventions to people with mental health
challenges.
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Neuro-Occupation
From a neuro-occupational perspective, the works of Gray, Kennedy, and
Zemke (1996), Lazzarini (2004), Padilla and Peyton (1997), and Royeen
(2002,2003) may be used to explore and describe the use of sensory
modulation-related occupational therapy interventions, such as the WB.
The process of self-organization governs neuroactivity and occupational
performance through the process of circular causality, as one experiences
and learns from the sensorimotor consequences of one’s actions in context
and over time (Freeman, 2000). Self-organization refers to the spontaneous
formation and adaptation of patterns and pattern change in dynamic systems,
such as human beings (Abraham, Abraham, & Shaw, 1990). Freeman asserts
that the self-organization of one’s actions is the product of context, previous
experience, states of arousal and attention, expectancies of responding to
stimuli and of one’s goals and meanings. In this view, occupation is the neu-
rodynamical process (occupation as means) that gives rise to the engagement
in meaningful activity (occupation as ends). The WB might be used as a pre-
paratory, purposeful, or occupation-based intervention to positively influence
occupational performance skills and participation (American Occupational
Therapy Association, 2014; Champagne, 2010,2011).
Trauma-Informed Care Interventions
Trauma-informed care is a national mental health initiative promoting a
model of care and advocates for the offering of interventions that are
empathic, empowering, client-centered, nurturing, sensory supportive and
do not contribute to re-traumatization (NETI, 2003, 2009; van der Kolk,
2006). Adult studies have demonstrated links between sensory processing,
anxiety, and trauma histories among adult consumers of mental health
services (Brown, Cromwell, Filion, Dunn, & Tollefson, 2002; Brown & Dunn,
2002; Brown, Tollefson, Dunn, Cromwell, & Filion, 2001; Kinnealey and
Fuiek, 1999; Kinnealey, Oliver, & Wilbarger, 1995; Moore & Henry, 2002;
Pfeiffer & Kinnealey, 2003). Thus, it is necessary to consider trauma, anxiety
and sensory processing symptoms and patterns, as variables affecting occu-
pational performance, health, wellness, and recovery. Trauma experts
recommend that interventions with people with trauma histories must first
focus on stabilization (Levine, 2005; Luxenberg, Spinazzola, Hidalgo, Hunt,
& van der Kolk, 2001). WBs are particularly promising in the area of
trauma-informed care because they can be used to help foster self-care,
self-nurturance, rest=sleep, and stabilization. The lack of existing evidence
supporting the use of WBs with people with mental illness and with trauma
histories, and the national initiatives advocating for sensory-based interven-
tions as part of recovery-focused and trauma-informed care, points to the
need for research.
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Encouraged by initial WB research findings, the authors explored and
published the first study on the safety and effectiveness of the use of using
a 30-pound WB among a heterogeneous, non-hospitalized volunteer, adult
population (Mullen et al., 2008). The results demonstrated that the use of a
30-pound WB was safe among the adult participants based on vital sign read-
ings of pulse oximetry, pulse rate, and blood pressure among the sample
population. EDA results indicated that 33%of the participants found the
WB to be effective in anxiety reduction. The perceived sense of relaxation
for many participants, however, was greater than indicated by the corre-
sponding EDA responses. For example, the State Trait Anxiety Inventory-10
(STAI-10) survey responses showed that over 60%of the participants found
the WB to be effective (Speilberger, Gorsuch, & Luchene, 1970). Additionally,
the exit survey results showed that 76%of the participants reported that the
use of the WB was an effective modality for reducing anxiety.
This article presents the results of an exploratory pilot study with an
adult, volunteer sample (n¼30) during an acute care inpatient mental health
hospitalization using a 30-pound WB. The hypotheses are as follows: (a) the
standardized use of the 30-pound WB will be safe to use among adults
hospitalized on an acute mental health inpatient unit, as evidenced by vital
signs data (heart rate, blood pressure, pulse rate); (b) the standardized use
of the 30-pound WB will be effective in decreasing anxiety for some of the
participants; and (c) the use of varied measures among a heterogeneous
population will yield inconsistencies as well as insights for future studies
(Portney & Watkins, 2000).
METHODS
Study Design
To assess the safety and effectiveness of the use of the 30-pound WB, an
exploratory, pilot study was employed within a controlled environment.
Safety metrics consisted of pulse, blood pressure, and pulse oximetry. A
pulse oximeter is a medical device that indirectly measures the oxygen satu-
ration of an individual’s arterial blood via the use of a spectrophotoelectric
instrument applied to the skin (Harkreader & Hogan, 2004). Efficacy metrics
consisted of galvanic skin response (Boucsein, 1992), the STAI-10 question-
naire (Stern, Ray, & Quigley, 2001), and a subjective self-rating 0–10 anxiety
scale. Galvanic skin response refers to change in the ability of the skin to
conduct electricity, caused by the effect of an emotional stimulus on the
operation of the sweat glands (Boucsein). The metrics were then studied
to determine if there were any changes in each participant’s vital signs, skin
conductance, and anxiety levels during the testing period.
To ensure symmetry, a random assignment and cross over design was
used to divide the participants into two equal groups, with each person
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receiving an even or odd code and number designation. The assigned code
determined whether the treatment (30-pound WB) was given during the first
or second test session. An even code required the use of the treatment during
the first testing session, and an odd code required use of the treatment during
the second testing session.
Participants
A heterogeneous population was used due to the lack of existing literature
identifying adult mental health consumers that might benefit from WB use.
Consecutive sampling was used to recruit adults (ages 18–64) willing to vol-
unteer for all portions of the study during an acute inpatient mental health
hospitalization. A sample size of 30 participants completed all portions of
the study, with an age range of 18–54, a mean age of 30.53 and a standard
deviation of 9.68. Eight participants were males and 22 were females, 80%
of the participants had a trauma history, and 33%had a history of restraint
use in previous hospitalizations. A randomized assignment procedure (even
and odd coding method) was used and helped create a cross-over design to
address ordering effect (Portney & Watkins, 2000).
Exclusion Criteria
The Allen Cognitive Level Screen (ACL) assesses global cognitive functional
ability (Allen, Earhart, & Blue, 1992). An ACL score of 4.8 or greater, and the
ability to understand and sign the informed consent document, helped
determine the cognitive ability to participate. Exclusion criteria also included
having open wounds, moderate to severe physical injuries, illiteracy, and a
positive pregnancy test upon admission. Although 40 participants met
inclusion criteria, only 30 participants completed all of the steps required
for study completion (n¼30). Of the 10 participants whose data were not
used due to lack of completion, reasons for exclusion included: discharge
prior to completion of all steps, anxiety related to the study procedures,
and the loss of willingness to participate with no reasons provided.
Setting
A 24-bed locked acute care mental health unit within a community hospital
was the study location. Each participant’s room and hospital bed was used to
conduct all aspects of the study. The room temperatures ranged between
65F–79F. The participant’s hospital bed and a privacy screen were used
to reduce environmental stimulation and to seclude the participants from
the monitoring equipment and data collectors during the monitoring activi-
ties. The only people allowed in the room included the participant and
two data collectors. During the monitoring phase, each participant’s door
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was closed and a sign was placed on the door to inform others that the study
was taking place and not to enter.
The Treatment: The WB
The treatment was the use of the 30-pound WB. The WBs used in the study
were custom made to weigh 30 pounds by Weighted Wearables (2015, Cozy
Comforter), with one side of the blanket offering fleece and the other side a
cotton fabric. For standardization purposes, only the fleece side was used
against the body of the participant. All persons participated in two test ses-
sions, one session with the treatment (the 30-pound WB), and one control
session without the treatment, as previously explained. During the control
session no WB was applied.
INSTRUMENTS AND MEASUREMENT TOOLS
Safety Measures
To determine whether the 30-pound WB is physiologically safe for the part-
icipants to use, vital sign metrics were compared when using and when not
using the WB, considering each individual’s vital sign baseline. The vital signs
collected included pulse rate, blood pressure, and pulse oximetry (non-
invasive measure for identifying oxygen saturation in the blood). Vital signs
are used by health care professionals to detect and monitor potential medical
issues related to circulation when not within normative ranges. Collecting
and comparing vital signs helped to show if the amount of weight from
the 30-pound WB was safe to use by adults while in the lying down position,
or if it caused any one or more of the vital signs to enter an unsafe region. If
vital signs entered into an unsafe region, this would be an indication that the
use of a 30-pound WB impaired breathing or blood circulation. Accordingly,
the quantitative vital signs were measured using blood pressure, pulse, and
pulse oximetry instruments, taking into consideration that blood pressure
and pulse rate decrease when sitting or lying down (Harkreader & Hogan,
2004). Each participant’s vital signs data, with the treatment and without
the treatment, were analyzed. Generally, the participants’ vital signs were
within the safety range acceptable for this study.
Effectiveness Measures
The previous study by the authors (Mullen et al., 2008) formed the basis for
the effectiveness metrics. Accordingly, EDA, the STAI-10 questionnaire and a
0–10 self-report anxiety measure were used to explore effectiveness. EDA is a
measure of galvanic skin response, or skin conductivity, which can be used
as an indication of one’s state of arousal (Boucsein, 1992). EDA has been
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observed to continuously change over time and is correlated to the activity of
the eccrine sweat glands. Located in the dermis, the eccrine sweat glands
regulate body temperature by manufacturing and excreting sweat onto the
skin’s surface (Stern et al., 2001). EDA can be measured through the collec-
tion of skin conductance and used as the quantitative indicator of anxiety
(Stern et al., 2001). In this study, skin conductance readings were obtained
using ProComp þskin conductance sensor from Thought Technology
(2015) using a constant-voltage sampling of skin conductance at a rate of
32Hz with an accuracy of 5%. The development of bias potentials and
polarization were minimized through the use of silver chloride cup electro-
des. Velcro fasteners were used to secure the electrodes to the volar surfaces
of the first and second distal phalanges of the right hand of each participant.
The STAI-10 (Speilberger et al., 1970) is a standardized, self-
administered questionnaire that measures perceived anxiety. The STAI-10
uses an ordinal scale, it is used for assessment and research purposes, and
validity and reliability have been established. Additionally, a 0–10 self-rating
anxiety scale (0 being the most calm one could feel and 10 representing the
extreme crisis state) was used to obtain a quantified self-reported measure of
perceived anxiety (McDowell, 2006).
PROCEDURE
Permission was received from Dartmouth Hitchcock’s Internal Review Board
and an informed consent document was thoroughly reviewed and signed by
each client willing to participate. On the first day of admission, a standar-
dized procedure was used to identify participants meeting inclusion criteria.
After a complete description of the study to the participants, those who were
interested were provided with the informed consent document to read and
sign. Questions were encouraged and answered before the volunteers signed
the informed consent document, as well as during the subsequent monitor-
ing phase. Recognizing that the novelty of the testing experience may influ-
ence test responses, the test environment, the equipment and procedures
were reviewed with the participants in a standardized manner prior to the
start of the monitoring phase.
The monitoring phase was conducted on the second day of admission.
The participant’s hospital room was first set up by the two data collectors,
and the participant was then brought in and encouraged to ask questions
related to the monitoring equipment. The participant then had all of the
monitoring equipment applied while seated on the hospital bed, and then
the equipment was activated by the researchers in a standardized manner.
Two researchers were present at all times to ensure consistency and accuracy
of testing procedures and data recording.
The STAI-10 was completed prior to lying down, and the 0–10 self-report
anxiety rating was also obtained from the participants and recorded by the
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researchers (Speilberger et al., 1970). Although in practice clients use WBs for
a longer period of time, a 5-minute timeframe was used for each monitoring
session, which was found to be sufficient by Mullen et al. (2008) to measure a
response. The 30-pound WB (Weighted Wearables, 2015,http://www.
weightedwearables.com/cozy_comforter.html) was applied during the first
of the two 5-minute monitoring sessions if the participant’s code was even,
with the fleece side against the body. If the participant’s code was odd, no
WB was applied for the first monitoring session. The participant was shielded
from the researchers and the equipment monitors by a standard hospital
screen during each session. At the end of the 5-minute monitoring period,
the participant’s vital signs, the STAI-10 and 0–10 self-rating anxiety scales
were all repeated. The monitoring equipment was removed and the partici-
pant was instructed to walk up and down the hallway of the unit for 5 minutes
to nullify the carry-over effect from lying down and use or non-use of the WB
(Mullen et al., 2008). The participant was then retrieved by the researchers
and the process was repeated, with no WB for those with even codes and with
the application of the WB for those with odd codes. This was a reversal of
intervention of the first session, with the even and odd numbers being
switched.
Statistical Analysis
For the analysis of the data on safety, vital signs were collected using a pre-
and post-test method and compared to adult norms. For the analysis of effec-
tiveness, statistical analysis included the use of t-tests to analyze the results,
focusing on the differences between the participants when compared to
themselves during treatment and control sessions (paired tests), and between
groups of participants (pooled tests). To further isolate and fully explicate the
effectiveness of the use of the 30-pound WB, the results were also analyzed to
study the influences of the ordering effect of the treatment sessions. Finally, a
Pearson’s correlation analysis was carried out to explore the relationship, if
any, between the two survey questionnaires (STAI-10 and self-rating), to
study whether the simple and easy-to-use self-rating would be a sufficient
indicator of participant’s dynamic, self-perceived anxiety states.
RESULTS
Safety
Pulse oximetry, pulse, and BP were monitored before and after each 5-minute
test period (both during the treatment and control phases), and pulse rate and
pulse oximetry were monitored continually throughout the 5-minute test ses-
sions as well. Table 1shows the results of the initial and final pulse oximetry
data for all participants, as well as the change over the 5-minute monitoring
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period. It is clear that none of the participants fell below the normative cut-off
value of 90%, designating the safe range for pulse oximetry.
A comparison of the results for both systolic BP (Figure 1) and diastolic
BP (Figure 2) and pulse rate (see Figure 3) also show that most of the part-
icipants stayed within the normative (safe) ranges, both during the treatment
and control phases. For the participants whose values were outside of the
normative ranges, the values were similar during both the treatment and
control phases, thus indicating that the WB was not the cause of deviation
outside of the normative (safe) range. From these results, it is concluded that
the use of the 30-pound WB did not cause any adverse influence on physio-
logical safety in terms of blood circulation, as evidenced by the three vital
signs data collected, for the entire 30 adult participants.
TABLE 1 Pulse Oximetry Results
Participant
number
Without blanket With blanket
Initial
O
2
Final
(after 5 minutes)
Net
change
Initial
O
2
Final
(after 5 minutes)
Net
change
CDH-002 99 99 0 99 97 2
CDH-003 97 97 0 97 98 1
CDH-004 98 98 0 98 98 0
CDH-005 96 97 196 95 1
CDH-006 96 95 1 96 96 0
CDH-007 97 96 1 97 99 2
CDH-009 98 97 1 98 97 1
CDH-010 99 99 0 98 99 1
CDH-011 95 92 3 95 97 2
CDH-013 99 99 0 99 99 0
CDH-015 96 95 1 96 95 1
CDH-016 96 96 0 97 97 0
CDH-017 99 99 0 99 99 0
CDH-018 99 99 0 99 99 0
CDH-019 98 96 2 98 95 3
CDH-020 99 99 0 99 99 0
CDH-023 98 97 1 98 99 1
CDH-024 99 98 1 98 97 1
CDH-025 97 95 2 97 95 2
CDH-026 98 97 1 98 97 1
CDH-028 98 97 1 98 97 1
CDH-029 99 99 0 99 99 0
CDH-030 93 92 1 93 95 2
CDH-032 99 98 1 98 97 1
CDH-034 97 96 1 95 94 1
CDH-035 99 99 0 99 99 0
CDH-037 98 97 1 98 97 1
CDH-038 98 97 1 97 96 1
CDH-039 99 99 0 99 99 0
Maximum 99 99 3 99 99 3
Minimum 93 92 193 94 2
222 T. Champagne et al.
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Effectiveness
EDA
Analysis of the EDA data did not show any conclusive evidence or signifi-
cance. For example, it was found that even though the participants were
in an acute mental health care setting, by the day of the monitoring (day
two of admission), participants’ EDA levels were relatively low and similar
to those of the adult, non-hospitalized participants in the first study (Mullen
et al., 2008). This may be due to the added influence of medications provided
to the participants in this study, which can affect EDA. Furthermore, the first
study outlines some of the difficulties associated with the analysis of low skin
conductance results, and the effect of a skin conductance floor (Mullen et al.,
2008). For these reasons, the effectiveness results will focus on the analysis
and results of the survey-based anxiety metrics from the STAI-10 and 0–10
self-rating anxiety scales.
FIGURE 1 Blood pressure comparison with and without the WB.
Safety and Effectiveness of the Weighted Blanket 223
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STAI-10 AND 0–10 SELF-RATING ANXIETY SCALES
Table 2shows the statistical results from STAI-10 and the 0–10 self-rating anxi-
ety data. The results are first shown for all participants, as well as for each
group. Group 1 is the set of participants to whom the treatment was applied
for the first 5-minute monitoring phase, and group two is the set of participants
for whom the treatment was applied during the second monitoring phase.
Overall, the results of the questionnaires appear to indicate that the data have
relatively high variances. The high variances can be attributed to the relatively
small sample size (n¼30) and the use of a heterogeneous population.
Throughout the study, a two-tailed t-test was used with a level of signifi-
cance set a priori at pvalue ¼0.05. The overall results show that there is no stat-
istical difference between the treatment and control situations from STAI-10
data (p¼0.164), while there is a significant improvement identified in the
0–10 self-rating data (p¼0.002). Further analysis of STAI-10 data from each
group corroborated the overall population data for group 1 (p¼0.226) and
FIGURE 2 Blood pressure comparison with and without the WB.
224 T. Champagne et al.
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TABLE 2 30-Pound WB Effectiveness
All participants
Effectiveness
STAI-10 Self-rating
Treatment Control Treatment Control
Mean 16.97 19.10 1.00 0.05
Variance 34.79 33.82 2.62 2.14
Observations (n)30 30 30 30
t-Statistic 1.41 2.38
P0.164 0.020
t-Critical two-tail 2.001 2.002
Effectiveness Group 1
Paired t-test STAI-10 Self-rating
Treatment Control Treatment Control
Mean 17.71 20.79 1.29 0.39
Variance 41.45 31.41 2.68 1.47
Observations (n)14 14 14 14
t-Statistic 1.27 3.78
p-Value 0.226 0.002
t-Critical two-tail 2.160 2.160
Effectiveness Group 2
Paired t-test STAI-10 Self-rating
Treatment Control Treatment Control
Mean 16.31 17.63 0.75 0.44
Variance (n) 30.36 33.18 2.60 2.53
Observations 16 16 16 16
t-Statistic 0.57 0.55
p-Value 0.576 0.590
t-Critical two-tail 2.131 2.131
FIGURE 3 Pulse rate results.
Safety and Effectiveness of the Weighted Blanket 225
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for group 2 (p¼0.576). Repeating the analysis with the results from the 0–10
self-rating data, however, it was found that there was a statistical improvement
for group 1 (p¼0.002) but no statistical difference for group 2 (p¼0.590).
To further explore the effectiveness of 30-pound WB, additional analysis
was performed to identify groups within the heterogeneous population that
may have benefited from the use of the treatment. For this purpose, the part-
icipants were identified as having (1) a positive effect (when there is a positive
change after the use of WB), (2) no effect (when there is no change), and (3)
negative effect (when there is a negative change after the use of WB). Table 3
shows the results of this categorization for the STAI-10. Here, 60%of the part-
icipants (18 out of 30) had a positive effect when using the 30-pound WB and
40%reported a negative experience. A similar analysis was carried out using
the 0–10 self-rating data. For this analysis, the net difference between the
pre-treatment and post-treatment was studied to identify the population with
a positive effect (see Table 3). Here, 66.7%had a positive experience when
using the 30-pound WB, with 20%indicating no change, and 13%experienc-
ing a negative effect. These results appear to indicate that the 30-pound WB
could be an effective anxiety reducing intervention in certain segments of
the adult acute inpatient mental health population. This inference provides
direction for future studies demonstrating the potential value of identifying
a more focused homogenous population.
ORDERING EFFECT
A concern in a study of this nature is to isolate and document any ordering
effect due to a possible residual effect of using the treatment in the first test-
ing session. The ordering effect was analyzed using a standard pooled t-test.
A two-tailed t-test with a level of significance set a priori at p¼0.05 was used.
The pooled t-test results are shown in Table 4. The results clearly indicate
that there is no statistical difference between group 1 and group 2 from
the STAI-10 and the 0–10 self-rating data, therefore, it can be concluded that
there was no ordering effect.
CORRELATION BETWEEN STAI-10 AND 0–10 SELF-RATING SCALES
This study also looked into the potential correlation in the results from the
two anxiety self-rating questionnaires. Correlation analysis can provide
further insight into whether both are needed for assessing the participants’
TABLE 3 Categorization Based on STAI-10 and Self-Rating Results
Change in STAI-10 from control
to treatment
Change in self-rating from
pre-treatment to post-treatment
Positive effect 18 (60.00%) 20 (66.67%)
No change 0 6
Negative effect 12 4
226 T. Champagne et al.
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perceived anxiety state. For this purpose, a Pearson correlation using the
SPSS software program was employed to investigate if there was a statistical
correlation between the STAI-10 and self-rating 0–10 anxiety measures. Using
an a priori level of significance of 0.01, strong significant correlation was
found when comparing the STAI-10 scores, the self-rating data for the treat-
ment situation (0.834), and for the control situation (0.552). While these
results are preliminary and in need of further research, the results suggest
that it may be sufficient to use either the STAI-10 or the 0–10 self-rating
survey for assessing the participants’ perceived, dynamic state of anxiety.
DISCUSSION OF RESULTS
The purpose of this exploratory, pilot study was to investigate the safety and
effectiveness of the standardized use of the 30-pound WB with a volunteer
consecutive sampling of 30 adults during an acute inpatient mental health
hospitalization. Blood pressure, pulse rate, and pulse oximetry monitoring
with and without the 30-pound WB were used as safety indicators. To study
effectiveness, multiple measures were used. Skin conductance and EDA
readings were measured to examine the participants’ state of arousal and
anxiety. Similarly, STAI-10 and self-rating exit questionnaires were used to
study the participants’ perceived reduction in anxiety after the use of the
WB (Speilberger et al., 1970). This study builds upon the authors’ prior
research on the use and benefits of WBs with adults (Mullen et al., 2008).
This is the first study, however, to explore the WB’s safety and effectiveness
with adults with mental illness.
TABLE 4 Ordering Effect From STAI-10 and Self-Rating Data
STAI-10 treatment STAI-10 control
Group 1 Group 2 Group 1 Group 2
Mean 17.71 16.31 20.79 17.63
Variance 41.45 30.36 31.41 33.18
Observations 14 16 14 16
t-Statistic 0.636 1.521
p-Value 0.530 0.139
t-Critical two-tail 2.056 2.048
Pooled t-test Self-rank treatment Self-rank cntrol
Group 1 Group 2 Group 1 Group 2
Mean 1.29 0.73 0.25 0.4
Variance 2.68 2.78 1.57 2.68
Observations 14 15 14 15
t-Statistic 0.900 1.204
p-Value 0.376 0.239
t-Critical two-tail 2.051 2.055
Safety and Effectiveness of the Weighted Blanket 227
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Exploration into the safety of the use of the WB was focused on the stan-
dardized use of the 30-pound WB, one of the heaviest on the market at the
time of the study, to identify whether there would be a negative impact on
vital signs (blood pressure, pulse rate, pulse oximetry) with an adult inpatient
mental health population. The results demonstrate no adverse effects on vital
signs with the use of the 30-pound WB using a similar methodology as in WB
study 1 (Mullen et al., 2008). Ultimately, the adult population in the first pub-
lished WB study (Mullen et al., 2008), had strikingly similar effectiveness and
safety results, as those revealed in the present study. It was found that 33%of
this population had a history of restraint use, none of the study participants
experienced restraint or seclusion throughout the hospitalization.
The STAI -10 and 0–10 anxiety self-rating results demonstrate that for
60%of the participants, the use of the 30-pound WB was effective in anxiety
reduction. Interestingly, the STAI-10 results from study 1 revealed the same
effectiveness outcomes for anxiety reduction (Mullen et al., 2008). Together,
these results indicate that regardless of diagnosis, a WB appears to provide a
calming effect for a significant segment of the participants. Though the initial
results are encouraging, the findings should also be interpreted with caution
due to its exploratory nature. Therefore, while these results cannot be gen-
eralized to all populations, this study supports previously published evidence
and provides a methodology for studying the WB from which to build upon
in future research.
Limitations
One limitation of the study is the use of a diagnostically heterogeneous adult
sample. Additionally, other potential influences include that all participants
were allowed the use of medications for mental health symptoms and all
became more familiar with the hospital environment after a 24-hour period;
both of these variables often influence a decrease in anxiety for many
people. Low anxiety levels were demonstrated by the low baseline EDA mea-
surements evidenced with most of the participants. In fact, the EDA data was
not used as a quantitative effectiveness measure, because the participant’s
anxiety levels remained too low for it to be a useful metric, similar to the
EDA methodology issues outlined in study 1 (Mullen et al., 2008). Other
physiological metrics, more sensitive to assessing calming are warranted in
future studies.
The main hypotheses of the study are that the standardized use of the
30-pound WB is safe to use with an acute, inpatient, adult mental health popu-
lation and that its use will be effective in decreasing anxiety for some parti-
cipants. To explore the specific hypotheses of this study, a standardized
protocol was used (5-minute timeframe, the amount of weight, weight place-
ment, and fabric type used against the person [fleece side down for all parti-
cipants]). The WB is typically used, however, in a client-centered manner. In
228 T. Champagne et al.
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occupational therapy practice, WB use is individualized to provide the
amount of weight, weight distribution, and timeframe that is most preferred
by the client, safe, and effective. For example, the amount of weight, fabric
type used against the body, time of day it is used, and the amount of time it
is used for, is determined collaboratively in practice. All of these factors play
a role in the perceived effectiveness of the use of the WB.
The use of a standardized protocol was also necessary for the purposes
of this study, due to the need to explore the safety of the use of the 30-pound
WB in a quantitative manner. This standardized protocol, however, may not
have been the most optimal for studying effectiveness outcomes, given that
the WB is used in a client-centered manner practice (individualized manner).
Additionally, having two researchers in the room during the monitoring
phase, while useful in helping to establish internal validity, may have also
influenced the results (may have been more calming for some or more anxi-
ety producing for others).
CONCLUSION
This study verifies the previous results of the authors, which indicated that the
use of a WB was safe for 100%and effective for 60%of the adult participants.
These findings provide an initial basis for further examination of the safety
and effectiveness variables involved with the use of WBs in the treatment of
adults with mental illness. More sensitive and compressive metrics are needed
to better capture the complex neurophysiological responses. Measurement
systems are also needed to further understand the neuroscience,
neuro-occupational, and trauma-care correlations involved in the use of
WBs. Future studies exploring the effectiveness and use patterns, employing
a client-centered methodology, will help to create evidence-based WB prac-
tice guidelines that inherently promote client-centeredness. Such a method-
ology may also be used to help identify WB variables that clients identify as
effective or ineffective, and the impact on occupational skills, performance
outcomes and recovery among varied populations. Finally, although
one-third of the participants had a history of the use of restraint and seclusion,
none of those participants required the use of restraint and seclusion during
the study. Thus, future studies exploring the correlations between WB use
as a preparatory method, for restraint reduction and stabilization purposes,
is warranted.
ACKNOWLEDGMENTS
The authors would like to thank the participants, Marie Chalifour, OTR=L;
Allison Berryman, OTR=L; and the hospital administration who helped to
support and conduct this research project.
Safety and Effectiveness of the Weighted Blanket 229
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... Edelson et al. [29] evaluated Grandin's squeeze machine on 12 children with autism randomly assigned to two groups (experimental and placebo groups) and then reported that administering deep pressure had a calming effect or benefit for children with autism with high levels of anxiety or arousal. The administration of deep pressure treatment with a 30-pound weighted blanket displayed no adverse effects on the user's vital signs (blood pressure, pulse rate, and pulse oximetry) targeting adult mental health consumers [30,31]. Research related to the effect of using a pressure vest has been conducted. ...
... Heart rate is one vital sign that is commonly used to measure the physiological effect of deep pressure devices [30,31,38]. Heart rate was measured using Elitech ® FOX-1 pulse oximetry (Surabaya, Indonesia) by recording blood oxygenation pulsations. ...
... The results showed that during the administration of a stressful film, the heart rate indicator did not show a significant difference, while the skin conductance showed a significant difference compared to a non-stressful film [45]. Similar results were also found in a study related to deep pressure application with a short period of application using a weighted blanket [30,31]. ...
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Traveling with children with autism can be very challenging for parents due to their reactions to sensory stimuli resulting in behavioral problems, which lead to self-injury and danger for themselves and others. Deep pressure was reported to have a calming effect on people with autism. This study was designed to investigate the physiological effect of deep pressure, which is an autism hug machine portable seat (AHMPS) in children with autism spectrum disorders (ASD) in public transportation settings. The study was conducted with 20 children with ASD (16 boys and 4 girls) at the Semarang Public Special School with an age ranging from 4 to 13 years (mean 10.9 ± 2.26 years), who were randomly assigned into two groups. The experiment consisted of group I who used the AHMPS inflatable wraps model and group II who used the AHMPS manual pull model. Heart rate (HR) and skin conductance (SC) were analyzed to measure the physiological calming effect using pulse oximeter oximetry and a galvanic skin response (GSR) sensor. Heart rate was significantly decreased during the treatment compared to the baseline (pre-test) session in group I (inflating wrap model) with p = 0.019, while no change of heart rate variability (HRV) was found in group II (manual pull model) with p = 0.111. There was no remaining effect of deep pressure using the HRV indicator after the treatment in both groups (group I with p = 0.159 and group II with p = 0.566). GSR captured the significant decrease in skin conductance during the treatment with p < 0.0001 in group I, but no significant decrease was recorded in group II with p = 0.062. A skin conductance indicator captured the remaining effect of deep pressure (after the treatment); it was better in group I (p = 0.003) than in group II (p = 0.773). In conclusion, the deep pressure of the AHMPS inflating wrap decreases physiological arousal in children with ASD during traveling.
... People with schizophrenia have been reported to experience high rates of SM deficits when compared with the general population Brown et al., 2020), and these sensory processing problems impact on daily occupational and social functioning (Barbic et al., 2019;Champagne, 2011a;Champagne et al., 2015;Fleischhacker et al., 2014;Lipskaya-Velikovsky et al., 2015;Yakov et al., 2018). ...
... In Mullen et al.'s (2008) concurrent, nested, mixed methods exploratory study on the therapeutic effects of weighted blankets, they found that 63% of participants had lower anxiety when using weighted blankets. Another exploratory study in an inpatient mental health unit found that 60% of participants reported a significant reduction in anxiety when they used weighted blankets (Champagne et al., 2015). However, the generalisability of these previous studies is limited because they had methodological problems such as relatively small samples, used convenience sampling, the samples being heterogenous, and not including control participants. ...
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... It also became more manageable for older people to fall asleep in the evening. Previous studies have also described this overall improved effect on sleep using the weighted blanket [40,70,71] Insomnia in older people is associated with cognitive impairment [15]. A weighted blanket can also affect depressive symptoms, which are alleviated in connection with sleep problems and vice versa [17]. ...
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... WMs reduce arousal through distraction, safe containment, and grounding, and have been found effective and safe for use with adults during inpatient mental health admissions (Champagne et al. 2015;Mullen et al. 2008;Sutton & Nicholson, 2011), although higher quality evidence and guidelines for use are needed (Eron et al. 2020). While most studies on sensory approaches, including use of WMs, have explored changes in consumers' self-rated distress and seclusion and/or restraint rates (Eron et al. 2020;Scanlan & Novak, 2015), few have explored whether the use of sensory approaches is associated with reduced use of PRN. ...
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