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Abstract

Introduction: A growing body of empirical, systematic research points to the efficacy of meditation as an aid to relieve stress and promote psychological wellbeing in both clinical and non-clinical populations. Mantra meditation however (the repetition of a word or phrase, silently or aloud), has yet to be evaluated with such rigour. Given this, a systematic review will be conducted to explore and synthesise existing research investigating the impact of mantra meditation on the health and wellbeing of those who engage in the practice. Methods: The protocol for the systematic review is conducted according to the PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols) guidelines. Electronic searches will be performed in the PsycINFO, MEDLINE, EMBASE, PUBMED and Scopus databases. Hand searches of the reference lists of identified studies will supplement the database search. Eligible articles will be independently assessed against inclusion criteria including but not limited to: the use of a control group, a non-clinical population, written in the English language and published in a peer-reviewed journal. Results: Data analysis will be completed and synthesised into a systematic review. The review will combine the existing literature on mantra meditation to date and offer insights about the effectiveness of mantra meditation programmes from a pragmatic perspective. Conclusion: This protocol will promote transparency of methods and research integrity in the systematic review, which will ultimately progress research in the field of mantra meditation. Systematic review registration: PROSPERO CRD42017079294
International Journal of Clinical Trials | April-June 2017 | Vol 4 | Issue 2 Page 88
International Journal of Clinical Trials
Dunne PJ et al. Int J Clin Trials. 2017 May;4(2):88-95
http://www.ijclinicaltrials.com
pISSN 2349-3240 | eISSN 2349-3259
Original Research Article
Feasibility study protocol to examine the role of mantra meditation at
reducing psychological distress in emergency department staff
Pádraic J. Dunne1*, Caoimhe O’Leary2, Lucia Prihodova2, Rachel Breen2, Cathal Walsh3,
Laurence Freeman4, Aine Carroll5, Geraldine McMahon6, Barry White7
INTRODUCTION
The practice of medicine by health care professionals
(HCPs), while often meaningful and rewarding, can have
a detrimental impact on psychological and physical
wellbeing, leading to emotional exhaustion1. Alongside
the impact of exposure to environmental hazards, HCPs
are at above-average risk of developing stress-related
psychological morbidities, substance abuse, and
dysfunctional interpersonal relationships.2 In particular,
the profession of emergency medicine, with its proclivity
for complex caseloads, high personal responsibility, and a
high-stress environment, can be emotionally and
physically arduous.3 Emotional exhaustion suffered by
HCPs, can have significant implications for the quality of
healthcare provided to patients1,4. Indeed, research
ABSTRACT
Background:
Work in a healthcare setting can affect the psychological wellbeing of healthcare professionals (HCPs).
Emotional exhaustion among HCPs can have a significant negative impact on the quality of healthcare provided to
patients in terms of increased medical errors and decreased patient satisfaction. There is a need for an effective stress-
reducing intervention, such as mantra meditation. This feasibility study will examine the suitability of random
controlled trial (RCT) methodology to assess the efficacy of mantra meditation at reducing emotional exhaustion
among emergency department (ED) staff.
Methods:
This is a mixed methods, stratified feasibility study with intent-to-treat protocol, using two study arms
(passive control and intervention), the purpose of which is to examine (1) recruitment, retention, and adherence; (2)
outcome measures (psychological wellbeing and stress-related biological parameters such as blood pressure, heart rate
variability and salivary cortisol); and (3) data management, control, and dissemination prior to conducting a full RCT.
Results
Eligible ED staff allocated to the intervention group (n = 30) will be taught mantra meditation and discuss
prescribed texts (4 x 4 hour session over 6 weeks), as well as engage in 20 minutes of twice-daily mantra meditation
practice. Participants in the passive control group (n = 30) will work as usual. Data will be collected pre (T1), post
(week 11; T2) and at follow-up (week 19; T3).
Conclusions:
This study will pave the way for a larger RCT that will investigate mantra meditation as a definitive
intervention to reduce emotional exhaustion among ED staff.
Keywords: Health care, Psychological, Stress, Emotional exhaustion, Meditation
1Room 0.50, Trinity Translational Medicine Institute, St. James’s Hospital Campus, Trinity College Dublin, Dublin,
D08 W9RT, Ireland; 2Royal College of Physicians of Ireland, Frederick House, 19 South Frederick Street, Dublin 2
3Health Research Institute, MACSI, Room B3038, Main Building, University of Limerick, County Limerick, Ireland
4Turvey Abbey, High St, Turvey, Bedford MK43 8DE, United Kingdom; 5National Director for Clinical Strategy and
Programmes Division, HSE, Dr Steevens' Hospital, Steevens' Lane, Dublin D08 W2A8, Ireland 6Department of
Emergency Medicine, St. James’s Hospital, Dublin 8, Ireland; 7National Centre for Hereditary Coagulation Disorders,
St. James’s Hospital, Dublin 8, Ireland
Received: 23 March 2017
Accepted: 08 April 2017
*Correspondence:
Dr. Pádraic J. Dunne,
E-mail: padraic.dunne@tcd.ie
Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.
DOI: http://dx.doi.org/10.18203/2349-3259.ijct20171919
Dunne PJ et al. Int J Clin Trials. 2017 May;4(2):88-95
International Journal of Clinical Trials | April-June 2017 | Vol 4 | Issue 2 Page 89
demonstrates an association between HCP emotional
exhaustion and reduced compassion and empathy,
increased medical errors, and decreased patient
satisfaction.5 There exists a clear and present need from
some kind of intervention to address this problem.
Growing evidence points toward the psychological and
physiological benefits of meditation practice on the
general population.6 While less attention has been
afforded to the potential gains for HCPs, a limited body
of research demonstrates the efficacy of meditation
(including mindfulness and mantra meditation) at
improving wellbeing among this cohort.
Common mindfulness courses promote non-judgemental
awareness of each thought, feeling and sensation on a
moment by moment basis.7,8 Mindfulness-based cognitive
therapy (MBCT) programmes have been well
characterised in the literature and usually involve 8 two-
hour sessions during which participants are taught a
number of different types of meditations that include
walking and sitting practices.8 The enhanced insight and
awareness gleaned from mindfulness meditation practices
can translate into considerable gains for HCPs, patients,
and the health service. This has been corroborated by
Beach et al, who found that patients were more likely to
give high ratings on clinical communication and to report
increased overall satisfaction with clinicians who practice
mindfulness meditation.9 Specifically, encounters with
such clinicians were more likely to be characterised by a
patient-centred pattern of communication and
conversation about psychosocial issues.9
On the other hand, mantra meditation usually involves
the repeated saying (internally or externally) of a
prescribed word, phrase or set of syllables, in a quiet
setting, for a set period of time each day.10 The
practitioner is urged to disengage from all internal and
external distractions, while focusing gently and
repeatedly on the mantra. Transcendental Meditation
(TM) is probably the best described type of mantra
meditation practice, however, many religious and non-
religious traditions have used mantra meditation as a
simple but effective means to calm the mind and promote
general wellbeing.10,11
Mantra meditation has also been evaluated scientifically
and found to improve health and wellbeing, albeit in
fewer studies. Elder and colleagues noted that a TM
programme reduced depression, anxiety and burnout in
20 secondary school teachers, while Anderson et al,
concluded that TM might induce clinically meaningful
reductions in systolic and diastolic blood pressure
measurements, based on a meta-analytic review of 9
clinical trials.12,13 In terms of health care practitioners,
Bormann reported in 2006 that manta meditation reduced
stress, state anger and anxiety, while it increased quality
of life in 42 American health care workers. Furthermore,
preliminary, unpublished data from the Royal College of
Physicians of Ireland (RCPI), demonstrated that mantra
meditation significantly reduced emotional exhaustion in
19 out of 26 HCP study participants. Despite these
studies, a significant knowledge gap exists regarding the
impact of mantra meditation on stress-related biological
parameters, including pro-inflammatory markers such as
interleukin (IL)-6 and Tumour Necrosis Factor (TNF)-.
Larger and more robust RCTs are required to confirm the
positive impacts of mantra meditation on health,
especially the wellbeing of HCPs.
We have chosen mantra meditation in this study because
it represents a cost-effective, flexible, portable, simple
and focused strategy for reducing stress and improving
well-being.14,15
Study aims and outcome measures
The aim of this feasibility study is to assess recruitment,
retention, adherence, physical resources, service access,
survey instruments, qualitative methodology and
managerial issues pertaining to this intervention (mantra
meditation to improve wellbeing in HCPs). The target
population will be HCPs working in a busy ED. It is
hoped that this feasibility study will provide a sound
basis for a larger RCT with the principle aim of using
mantra meditation to reduce psychological distress
among HCPs. Secondly, should the intervention prove
successful, the ultimate goal will be to engage with
hospitals across Ireland to provide rolling mantra
meditation programmes, dedicated to improving the
wellbeing of this group of professionals. We aim to
develop a sound, evidence-based programme that can be
replicated throughout Ireland, using mantra meditation
manuals produced as a result of this study. In the long-
term, we will also examine the biological mechanisms
behind HCP distress and how mantra meditation might
impact on the immune system, brain structure and
epigenetic control of pro-inflammation.
Primary outcome measure
Change from baseline in ED staff emotional
exhaustion using the Maslach Burnout Inventory
(MBI), examined on weeks 11 and 19.
Secondary outcome measures
Change from baseline in retention and adherence of
study participants from both arms, when examined
on weeks 11 and 19.
Change from baseline in ED staff anxiety and
depression scores, as measured by the Depression,
Anxiety and Stress Scale (DASS) on weeks 11 and
19.
Change from baseline in levels of mindfulness
among ED staff, as measured by the Five Facet
Mindfulness Scale (FFMS) at weeks 11 and 19.
Enhanced Professional Quality of Life Scale
(PQoLS) scores on weeks 11 and 19, compared with
baseline for participants in the intervention arm.
Dunne PJ et al. Int J Clin Trials. 2017 May;4(2):88-95
International Journal of Clinical Trials | April-June 2017 | Vol 4 | Issue 2 Page 90
Changes in safety attitudes related to teamwork,
safety climate, job satisfaction, perceptions of
management, stress recognition and working
conditions, as measured by the Safety Attitudes
Questionnaire (SAQ) on weeks 11 and 19.
Reduced 24 hour ambulatory blood pressure (ABP)
compared with baseline when measured on week 11
for participants in the intervention arm.
Change from baseline of heart rate variability as
measured daily by individual Fitbit wearable devices,
with final measures on week 11.
Change from baseline in the number of participants
from the intervention arm, adhering to daily
meditation practice, as measured by a bespoke
application (app) linked to an individual Fitbit
device.
Change from baseline in participant salivary cortisol
using Enzyme-linked Immunosorbent Assay
(ELISA) on week 11.
Store blood samples for subsequent immunological
and epigenetic analysis.
Impact on participants in the intervention arm, measured
through qualitative interviewing and logbooks on week
19.
METHODS
Study design
The design of this feasibility study is based on the
guidelines for non-pharmacological clinical trials by
the Consolidated Standards of Reporting Trials
(CONSORT) group.16 This is a stratified feasibility RCT
with an intent-to-treat protocol, using two study arms
(passive control and intervention) with single blind
outcome assessors, based at a single centre (St. James’s
Hospital, Dublin). Once ethical approval was obtained,
eligible, consenting ED staff was randomised into two
experimental groups: passive control group and mantra
intervention group (Fig. 1).
Stratified randomisation allowed firstly for equal gender
ratios in each group and secondly, equal distribution of
individuals from different ED roles (nursing, other health
care professionals, allied health care staff, administrative
staff and medical). A comprehensive list of inclusion and
exclusion criteria can be found in Tables 1 and 2.
Table 1: Inclusion criteria
Inclusion criteria
Staff member (nurse or doctor) of the ED
department of St. James’s hospital, Dublin
Preference to participate in the study
Over the age of 18 years
Table 2: Exclusion criteria.
Participants allocated to the intervention group (n = 30)
will discuss prescribed texts (related to meditation
practice and the meaning of healthcare) and learn mantra
meditation over a 6-week period (4 x 4 hour sessions),
accompanied by 20 minutes of twice-daily mantra
meditation practice. Participants in the passive control
group (n = 30) will work as usual and will not attend
regular meetings. Data will be collected at 3 time points
(T1-3): pre- (two weeks before intervention; week 1),
post- (three weeks after intervention ends; week 11), and
at a two month follow-up (week 19). Participant feedback
on the intervention and the research study as well as
experiences of learning meditation will also be sought
through qualitative interviews (week 19). Intervention
fidelity will be ensured through a syllabus checklist,
which will be marked after each session by facilitators
and independent observers.
Recruitment
Staff at the Health Research Board of Ireland (HRB)
Wellcome Clinical Research Facility (CRF) based at St.
James’s Hospital will act as data controllers and
recruiters of study participants. A presentation of the
study aims and objectives was provided to all ED staff,
after which, study recruitment posters and information
booklets were distributed. Interested staff members
contacted the CRF directly by email or telephone to
express interest in participating in the study. Volunteers
who passed the inclusion and exclusion criteria (Tables 1
and 2) were asked to join the study and allocated a unique
identification code (P001 to P060) post randomisation.
Eligible participants were taken through a detailed pre-
approved consent form by CRF staff, prior to enrolment.
This process ensured no interference in the recruitment
process by the trial organisers; all outcome assessors will
be blind to individual participant identification
throughout the study.
Dunne PJ et al. Int J Clin Trials. 2017 May;4(2):88-95
International Journal of Clinical Trials | April-June 2017 | Vol 4 | Issue 2 Page 91
Randomisation
The participants were stratified by work role and gender.
Computer generated random numbers were generated to
allocate to treatment or control group by an independent
statistician. Researchers remained blinded to treatment
allocation.
Mantra meditation intervention programme
Four mantra meditation contact sessions will take place
over two consecutive weeks followed by two fortnightly
sessions (total of 6 weeks). Each session will be four
hours, inclusive of two 10 minute break periods. Two
experts in the area of mantra meditation and healthcare
provision will co-deliver each session, which will be
delivered in line with a structured manual. The objectives
of the programme are to teach participants the basic
principles and practice of mantra meditation, to support
the embedding of the practice of mantra meditation in the
daily life of participants, and to facilitate the development
of an increased level of awareness. A number of key tools
will be used to achieve these objectives, including: the
provision of structured talks within a classroom setting
(the same talks will be uploaded onto the bespoke study
application each week), meditation practice during the
class, Q and A sessions with teachers, and online support
throughout the programme. Specific texts were chosen to
support the themes of each session, which include: how
to meditate, distractions, developing the practice, being
versus doing, attention, stages of meditation and the
meaning of health, suffering and death. The mantra used
in this study will be the Aramaic word maranatha, which
is usually broken into four syllables: ma-ra-na-tha.
Retention and adherence of the study participants will be
carefully monitored throughout the programme.
Bespoke application linked to a wearable Fitbit® device
A bespoke application, linked to a wearable Fitbit®
device will be used to promote adherence to daily
meditation (Figure 2). The app will record heart rate
variability, movement and sleep via a Fitbit® device
when the participant utilises the app timer. The app will
also record the duration and frequency of meditation
practice on a daily basis. Participants from both control
and intervention groups will wear an individual Fitbit®
device that will record heart rate variability and sleep
patterns for the duration of the programme (6 weeks).
However, only recruits from the intervention group will
download a bespoke app to their smartphone (Android
and Apple devices), which will link to the Fitbit® device.
All data will be anonymised and gathered for analysis at
the end of the 6 week programme period.
Sampling and time points
All study participants (passive control and intervention
group) will be invited to complete questionnaires (Table
3), on one of the following days at each time point: Time
1 (two weeks before session 1); Time 2 (three weeks after
session 4); Time 3 (two months after the end of the
programme) (Figure 1). Blood and saliva samples will be
gathered on Times 1 and 2 only and will be processed for
long-term storage at -80oC in monitored freezers.
Analysis of these biological samples will be subject to
additional funding.
Figure 2: Bespoke application and wearable Fitbit® device.
A bespoke application designed specifically for this project (includes a meditation timer and programme audio files) will be used to
promote adherence to daily meditation practice. Heart rate variability measurements will be taken by a wearable Fitbit® device during
meditation practice; heart rate variability data will subsequently be downloaded by the study application, which can be accessed by the
data controller.
Dunne PJ et al. Int J Clin Trials. 2017 May;4(2):88-95
International Journal of Clinical Trials | April-June 2017 | Vol 4 | Issue 2 Page 92
Figure 1: Participant flow during the study, including time points for questionnaires and biological sampling.
Table 3: Biological samples and planned future
investigations.
Sample
Investigation
3 ml whole blood
(EDTA)
Serum pro-inflammatory
cytokines (Interleukin [IL-6],
Tumour Necrosis
Factor[TNF]-)
8.5 ml whole blood
(PaxGene DNA)
Epigenetic modification of
DNA
2.5 ml whole blood
(PaxGene mRNA)
Pro-inflammatory cytokine
mRNA (IL-6, TNF-)
1 ml saliva
Salivary cortisol
Data collection and management
All participants will complete questionnaires at pre-
intervention (T1), post-intervention (T2) and at two
month follow-up (T3). Participants will be asked to
complete questionnaires at the CRF. All data will be
pseudo-anonymised and stored on password-protected
computers in locked locations by the data controller.
Statistical analysis and appropriate collation of data will
be under the supervision of a study statistician and the
CRF data controller. All outcome assessors will be
blinded. All personal data will be stored in a secure
Dunne PJ et al. Int J Clin Trials. 2017 May;4(2):88-95
International Journal of Clinical Trials | April-June 2017 | Vol 4 | Issue 2 Page 93
environment on encrypted computers, in accordance with
the Irish Data Protection Act (1998).
24-hour ambulatory blood pressure (ABP)
measurements
Participants from both study groups will wear a 24 hour
ABP monitor for a 24 hour period at time points 1 and 2
(weeks 1 and 11). Blood pressure readouts will be
analysed by blind outcome assessors at the end of the
study programme.
Study questionnaires
Maslach Burnout Inventory (MBI; Maslach et al, 1986)
The MBI is a 22-item scale designed to measure burnout
in human services professionals. It comprises three
subscales which examine emotional exhaustion,
depersonalisation and personal accomplishment. It has
since been validated as a reliable and reproducible survey
instrument by numerous studies17.
Depression, Anxiety and Stress Scale (DASS; Lovibond et
al, 1995)
The DASS represents a widely used, valid and
reproducible screening tool to assess symptoms of
depression, anxiety, and stress in different community
settings, including hospitals18. It is a 21-item inventory
comprising three sub-scales: (a) the depression sub-scale
which measures hopelessness, low self-esteem, and low
positive affect; (b) the anxiety scale which assesses
autonomic arousal, musculo-skeletal symptoms,
situational anxiety and subjective experience of anxious
arousal; and (c) the stress scale which assesses tension,
agitation, and negative affect.
Professional quality of life scale for compassion
satisfaction and compassion fatigue version 5 (Pro-QOL;
Stamm et al, 2005)
The ProQOL scale to addresses compassion levels in
HCPs. It comprises three subscales: compassion
satisfaction (pleasure derived from helping others),
burnout, and compassion fatigue. It is widely regarded as
a reliably valid instrument for measuring compassion
levels in HCPs17.
Five Facet Mindfulness Questionnaire (FFMQ;)19
The FFMQ is a reliable and validated 39-point
questionnaire that measures an individual’s level of
mindfulness. The five subsets examined by this survey
instrument include: observing (watching internal
experiences both physical and mental), describing
(labelling internal experiences), acting with awareness,
non-judgement and non-reactivity (to internal and
external stimuli). Although this study will not apply
mindfulness-based techniques, mantra meditation
practice, cultivates the trait or state of mindfulness;
therefore, we expect the FFMQ responses to change in
individuals randomised to the mantra meditation group.
Safety Attitudes Questionnaire (SAQ; 30-item inventory)
Safety culture will be measured by the SAQ, a tool which
is widely used, has good psychometric properties and is
associated with clinical outcomes20. The SAQ comprises
six domains; teamwork climate, safety climate, job
satisfaction, perceptions of management, stress
recognition, and working conditions. Each item on the
SAQ is rated on a 5 point Likert scale.
Qualitative Methodology (semi-structured interviews and
logbooks)
Semi-structured interviews, lasting approximately 30
minutes, will be conducted with a subsample of
participants who received the intervention (target n = 10).
Potential consenting participants will be emailed a study
information sheet (on T3) outlining the broad topics to be
explored: benefits and risks associated with participating,
confidentiality, use of data, and the time commitment
required. During the interview, questions will focus on
gaining participants’ insights into the following: delivery
of the intervention, perceived barriers, facilitators, daily
meditation practice as well as any experienced benefits or
negative impacts of meditation. In addition, the interview
will explore the effect of meditation on their work
performance and on perceived impact on their patients,
colleagues, and the healthcare organisation. The
interview topic guide will be developed in the context of
an appropriate health psychology model of coping and
wellbeing. Interviews will be audio-recorded and
transcripts will be thematically analysed taking a realist,
phenomenological approach.
Participant logbooks
Participants will be encouraged to add entries to their
logbooks on a weekly basis, in response to three basic
questions. These questions will be designed to gather
information related to their thoughts and feelings on their
meditation practice, impact on personal and work life
balance and any other relevant topics.
Statistical assessment
Statistical analysis will be carried out by statistician
(blind outcome assessor) using R statistical software,
supported with SPSS v23. Data will be analysed using
simple descriptive and inferential statistics (t-test and
analysis of variance methods; longitudinal analysis will
be employed using repeated measures and analysis of
covariance methods). Methods to integrate all the data
will be developed and operationalised to allow for full
assessment of the effectiveness of the intervention. The
level of significance for all tests will be set at p<0.05.
Dunne PJ et al. Int J Clin Trials. 2017 May;4(2):88-95
International Journal of Clinical Trials | April-June 2017 | Vol 4 | Issue 2 Page 94
Power calculations
The number of participants has been selected for a study
of a continuous response variable from independent
control and experimental subjects with 1 control per 1
experimental subject (30 versus 30). In a pilot study by
RCPI, which assessed the impact of mantra meditation on
work-related stress using the MBI (among others, it was
found that the response within each subject group for
emotional exhaustion was normally distributed with a
mean score of 26.8 pre- and 22 post-intervention for all
subjects (n=19). We are planning a study of a continuous
response variable from matched pairs of study subjects.
Prior data indicate that the difference in the response of
matched pairs is normally distributed with standard
deviation 12.3. If the true difference in the mean
response of matched pairs is 3.8, we will need to study 84
pairs of subjects to be able to reject the null hypothesis
that this response difference is zero with probability
(power) 0.8. The Type I error probability associated with
this test of this null hypothesis is 0.05. However, power
calculation requirements will not be met in this instance,
as this is a feasibility study, the sole purpose of which is
to determine whether it is feasible to conduct such a study
on a larger scale. The results of this power calculation
will be applied in the subsequent larger RCT.
(calculations were made using PS software;
http://biostat.mc.vanderbilt.edu/wiki/Main/PowerSample
Size).
Ethics
Ethical approval for access to consenting ED staff has
been approved by the Joint Ethics Committee (JAC) of
St. James’s and Tallaght Hospitals, prior to commencing
recruitment (2016-07). Participants received short
information booklets to explain the study outline as well
as a clear and concise pre-approved consent forms.
Risk associated with the project design
Time taken and inconvenience for study participants
(medium risk)
Potential identification of interviewees from audio
files (medium risk)
Poor recruitment rates (medium risk)
High dropout rate (medium risk)
Poor meditation homework adherence (high risk)
Methods for protecting against bias
The following categories of bias will be addressed in the
study design and throughout the project:
Selection bias
Consenting volunteers will come from the same ED
department, located in St. James’ hospital. Furthermore,
recruits will be processed through a stratified
randomisation design that will ensure equal gender ratios
in each group, as well as even distribution of different ED
roles. Strict exclusion and inclusion criteria were applied
for potential participants (Tables 2 and 3).
Performance bias
Since participants will all come from the same ED,
contamination between groups is a possibility. Members
of the intervention group will be encouraged not to
discuss meditation or the intervention with colleagues in
the passive control group. Since homework adherence
remains an issue with interventions that require daily
meditation practice, we will use a bespoke application
coupled with a wearable Fitbit® device to monitor heart
rate variability during daily meditation practice.
Attrition bias
A 24% (6 out of 25) attrition rate was observed in the
recent RCPI pilot study (unpublished). As a result, we
might assume similar attrition rates in this study. Drop-
out might also become an issue for the two-month
follow-up time point.
Detection bias
We will ensure that the length of follow-up will be the
same in both groups (two months from the last session for
either group). Outcome assessors responsible for
collating and processing survey material will be blinded
as to the group status of study participants. Furthermore,
the intervention survey instruments represent valid,
reliable measures for HCPs that will be applied across
both groups.
Adverse event reporting
Based on previous studies as well as the nature of the
intervention, we expect that participants will not
experience any side effects of the intervention. Yet, in the
unlikely scenario, adverse events will be recorded and
reported to the JAC of St. James’s and Tallaght
Hospitals. The CRF data controller will report any
adverse effects to the PI who will generate an incident
report for the trial oversight committee. Consenting
participants in need of psychological or medical
assistance will be referred on for assistance.
Trial status
Participants have been recruited and randomised as of
January 31st 2017.
DISCUSSION
This feasibility pilot study will pave the way for an
efficient, effective and larger RCT that will test whether
or not mantra meditation can reduce emotional
exhaustion in staff working in large hospital departments.
In the long term, we hope to provide a manual of stress
Dunne PJ et al. Int J Clin Trials. 2017 May;4(2):88-95
International Journal of Clinical Trials | April-June 2017 | Vol 4 | Issue 2 Page 95
reduction using mantra meditation for HCPs that will
advise hospital departments in the set-up and
maintenance of an ongoing mantra meditation
programme. It is envisioned that this manual will
subsequently help guide advances in HCP self-care
leading to improved well-being, reduced costs and
improved patient satisfaction and safety.
ACKNOWLEDGEMENTS
We would like to acknowledge the Health Research
Board, Wellcome-Clinical Research Facility (CRF) at St.
James’s Hospital, Dublin, for their assistance with this
trial in terms of recruitment, samples acquisition and data
control.
Funding: This project is a joint collaboration between the
Royal College of Physicians of Ireland (RCPI), Trinity
College Dublin and St. James’s Hospital Dublin and
funded by the Health Service Executive of Ireland
Conflict of interest: None declared
Ethical approval: The study was approved by the
Institutional Ethics Committee
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... Considering the existence of ruwatan tradition known since Majapahit period, it belongs to local wisdom of Javanese people. Local wisdom [10] is any form of knowledge, belief, understanding or insight, and custom or habit or ethic In the performance of ruwatan Murwakala ritual with shadow puppets will relate to sacred matters mostly during the reciting of mantram in the ruwatan ceremony [11]- [13]. The reciting of mantram starts in the scene where Bathara Kala meets with puppeteer character called Kandha Buana. ...
... Stress management is therefore crucial for both mental and physical well-being during the pandemic, and one major tool for combating the negative effects of stress is meditation (see section below on Lifestyle Factors for additional tools to help manage stress, most notably the section on exercise). In fact, numerous studies over recent decades have demonstrated the benefits of meditation for many facets of physical, emotional, and mental health (Lynch et al. 2018). This practice may be particularly relevant at this time given that many individuals do not have access to their regular stress relief outlets (going to the gym, gathering with friends, etc.). ...
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The COVID-19 crisis has created a "mental health pandemic" throughout the world. Scientific data are not available to fully understand the nature of the resulting mental health impact given the very recent onset of the pandemic, nevertheless, there is a need to act immediately to develop psychotherapeutic strategies that may alleviate pandemic-related distress. The psychological distress, in particular fear and sadness, is a function of the pandemic's negative impact upon people's ability to meet their most basic needs (e.g., physical safety, financial security, social connection, participation in meaningful activities). This paper presents evidence-based cognitive behavioral strategies that should prove useful in reducing the emotional suffering associated with the COVID crisis.
... Stress management is therefore crucial for both mental and physical well-being during the pandemic, and one major tool for combating the negative effects of stress is meditation (see section below on Lifestyle Factors for additional tools to help manage stress, most notably the section on exercise). In fact, numerous studies over recent decades have demonstrated the benefits of meditation for many facets of physical, emotional, and mental health (Lynch et al. 2018). This practice may be particularly relevant at this time given that many individuals do not have access to their regular stress relief outlets (going to the gym, gathering with friends, etc.). ...
Article
Full-text available
The COVID-19 crisis has created a “mental health pandemic” throughout the world. Scientific data are not available to fully understand the nature of the resulting mental health impact given the very recent onset of the pandemic, nevertheless, there is a need to act immediately to develop psychotherapeutic strategies that may alleviate pandemic-related distress. The psychological distress, in particular fear and sadness, is a function of the pandemic’s negative impact upon people’s ability to meet their most basic needs (e.g., physical safety, financial security, social connection, participation in meaningful activities). This paper presents evidence-based cognitive behavioral strategies that should prove useful in reducing the emotional suffering associated with the COVID crisis.
... Stress management is therefore crucial for both mental and physical well-being during the pandemic, and one major tool for combating the negative effects of stress is meditation (see section below on Lifestyle Factors for additional tools to help manage stress, most notably the section on exercise). In fact, numerous studies over recent decades have demonstrated the benefits of meditation for many facets of physical, emotional, and mental health (Lynch et al. 2018). This practice may be particularly relevant at this time given that many individuals do not have access to their regular stress relief outlets (going to the gym, gathering with friends, etc. ...
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The COVID-19 crisis has created a “mental health pandemic” throughout the world (Marques et al. 2020; Strakowski et al. 2020) as a result of its impact upon people’s day-to-day functioning. A recent survey by the Kaiser Family Foundation found that 56 percent of people reported that the worry or stress tied to COVID had a negative effect on their emotional well-being (Panchal et al. 2020), and as the duration of the pandemic increases, it is likely to lead to even more psychological distress. Scientific data are not available to fully understand the nature of the resulting mental health impact given the recent onset of the pandemic, but there is a need to act immediately in order to develop strategies that may alleviate psychological distress. During the past two months we have identified the nature of pandemic-related distress by using our clinical observation skills to identify triggers and resultant psychological problems we were seeing in our patients, family, friends— and our own lives. Once we created this list we developed a self-help guide composed of strategies that allow those affected to manage their negative emotional states. The self-help guide is quite thorough and can be used in conjunction with the current paper in order to maximize the effectiveness of mental health professionals ability to reduce pandemic-related distress. Nearly all of the therapeutic techniques that we included were adopted from evidence-based cognitive behavioral treatments. We expect that these strategies will prove useful for those suffering the emotional challenges associated with the COVID crisis. This paper also a discussion of a preliminary, scaleable consultation-oriented intervention that we developed (cf: Limowski et al. 2020) and are in the process of field-testing to determine if it is in fact feasible and effective in reducing pandemic-related psychological distress. Finally, we discuss the possibility of posttraumatic growth as a potential positive outcome that occurs when individuals are faced with negative circumstances.
... Stress management is therefore crucial for both mental and physical well-being during the pandemic, and one major tool for combating the negative effects of stress is meditation (see section below on Lifestyle Factors for additional tools to help manage stress, most notably the section on exercise). In fact, numerous studies over recent decades have demonstrated the benefits of meditation for many facets of physical, emotional, and mental health (Lynch et al. 2018). This practice may be particularly relevant at this time given that many individuals do not have access to their regular stress relief outlets (going to the gym, gathering with friends, etc.). ...
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Full-text available
As a result of this pandemic, we are all serving in an enormous social experiment thatwill allow researchers to determine the impact of chronic fear, countless losses, social isolation, andsignificant disruption of people’s day to day lives.We are concerned that if this is left unattended, themental health impact of these factors may be disastrous. The good news is that we have effectivestrategies to help individuals manage negative emotional states.All of the strategies that we are outlining in this document are taken from evidence-based psychologicaltreatments for individuals with anxiety disorders and depression. Thus, there is no reason to expect thatthese strategies cannot be equally useful for those suffering from similar emotional states secondary tothe challenges associated with the COVID crisis.Typically, when we produce a paper in academics, we spend months planning, writing, and reviewing itbefore making it available to others.Given the current rapidly evolving crisis we do not have time forthat.As a result, we are doing something highly unusual - releasing a work in progress that is likely todevelop over the next several months as we learn more about the impact of the COVID crisis on mentalhealth. The first version, released last week on 4/6/20, was produced in two days.The second versionwas produced in nine days. We know it is not perfect, but still believe it can be useful and thus is worthreleasing before it meets our standard -- but is too late.Please note that the second version has been substantially improved.Most of the areas covered in thefirst version have been edited, many new areas have been added (these are noted in the table ofcontents).And perhaps equally important, the document and website have
... The protocol for this systematic review has been published and is available online. 22 The original protocol specified the review would report on the impact of mantra meditation on physical, psychological, cognitive, social and occupational health. This review is refined to mental health related outcomes only. ...
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Introduction: Meditation has attracted increased attention in the literature as a non-pharmacological strategy to foster positive mental health amongst the general population. This systematic review aims to summarise studies of mantra meditation (which includes Transcendental Meditation, TM®) to understand its potential value in fostering positive mental health and alleviating negative affectivity in non-clinical populations. Methods: Electronic databases were searched for English language, peer-reviewed empirical studies (published between 1970 and 2018) that related to mantra meditation, reported at least one outcome of mental health and utilised healthy, non-clinical populations. Studies were assessed for quality and risk of bias using the Quality Appraisal Tool for Quantitative Studies (QATQS). Data abstraction was facilitated by a tailored data extraction form. Results: A total of 2171 records were identified, of which 37 were included in this review. Studies report on outcomes of anxiety, stress, depression, burnout, anger and psychological distress. 78% of studies utilised the TM programme. Findings indicate that mantra meditation interventions may have minimal to moderate beneficial effects on mental health in general populations. Over 90% of studies were considered to be of weak quality. Conclusions: There is some evidence that mantra meditation can improve mental health and negative affectivity in non-clinical populations, however poor study quality may hinder the extent to which one can be certain about the accuracy of these findings. Mantra meditation may be considered a useful adjunct to workplace wellbeing initiatives or educational programmes. Further studies of higher quality that incorporate cost-effectiveness analyses are warranted.
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Women and families are the fastest growing segment of the homeless population. Negative attitudes of nurses toward homeless women are a major barrier to homeless women seeking health care. This cross-sectional, mixed-methods pilot study, conducted primarily by nurses, tested the Mantram Repetition Program for the first time with 29 homeless women. The Mantram Repetition Program is a spiritually based skills training that teaches mantram (sacred word) repetition as a cost-effective, personalized, portable, and focused strategy for reducing stress and improving well-being. For the cross-sectional, pretest-posttest design portion of the study, the hypothesis that at least half of the homeless women would repeat their mantram at least once a day was supported with 88% of the women repeating their mantram 1 week later. The qualitative portion of this study using phenomenology explored the women's thoughts on mantram week 2. Themes of mantram repetition, mantram benefits, and being cared for emerged. This groundbreaking, interventional, mixed-methods pilot study fills a gap in interventional homeless research.
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Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. We describe the development of a reporting guideline, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium.
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Background The prevalence and socioeconomic cost of late life depression (LLD) is on the rise, while the response rate to antidepressant trials remains poor. Various mind-body therapies are being embraced by patients as they are considered safe and potentially effective, yet little is known regarding the effectiveness of such therapies to improve LLD symptoms. Among the mind-body therapies currently in practice, the results of our pilot study have shown that a particular meditation technique called Sahaj Samadhi Meditation, which belongs to the category of meditation termed automatic self-transcending meditation (ASTM) may have some promise in improving cardiovascular autonomic disturbances associated with LLD as well as ameliorating symptoms of depression and anxiety. Methods/Design Patients between the ages of 60 and 85 with LLD will be randomized either to ASTM plus treatment as usual (TAU) or TAU alone to assess changes in cardiovascular autonomic parameters, neuropsychological symptoms of depression and anxiety as well as quality of life. The instructional phase of the intervention consists of 4 consecutive days of meditation training, after which participants are encouraged to meditate twice daily for twenty minutes each time at home. The intervention also includes once weekly follow up sessions for the subsequent 11 weeks. The planned study has one and a half year recruitment period. Participants will be assessed at baseline and at 4, 8, 12 and 24 weeks post intervention. Discussion This study should provide a unique data source from a randomized, controlled, longitudinal trial to investigate the effects of a form of ASTM on cardiovascular autonomic and neuropsychological health in LLD. Trial registration Clinicaltrials.gov NCT02149810, date registered: 05/28/2014.
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Purpose: Mindfulness (ie, purposeful and nonjudgmental attentiveness to one's own experience, thoughts, and feelings) is associated with physician well-being. We sought to assess whether clinician self-rated mindfulness is associated with the quality of patient care. Methods: We conducted an observational study of 45 clinicians (34 physicians, 8 nurse practitioners, and 3 physician assistants) caring for patients infected with the human immunodeficiency virus (HIV) who completed the Mindful Attention Awareness Scale and 437 HIV-infected patients at 4 HIV specialty clinic sites across the United States. We measured patient-clinician communication quality with audio-recorded encounters coded using the Roter Interaction Analysis System (RIAS) and patient ratings of care. Results: In adjusted analyses comparing clinicians with highest and lowest tertile mindfulness scores, patient visits with high-mindfulness clinicians were more likely to be characterized by a patient-centered pattern of communication (adjusted odds ratio of a patient-centered visit was 4.14; 95% CI, 1.58-10.86), in which both patients and clinicians engaged in more rapport building and discussion of psychosocial issues. Clinicians with high-mindfulness scores also displayed more positive emotional tone with patients (adjusted β = 1.17; 95% CI, 0.46-1.9). Patients were more likely to give high ratings on clinician communication (adjusted prevalence ratio [APR] = 1.48; 95% CI, 1.17-1.86) and to report high overall satisfaction (APR = 1.45; 95 CI, 1.15-1.84) with high-mindfulness clinicians. There was no association between clinician mindfulness and the amount of conversation about biomedical issues. Conclusions: Clinicians rating themselves as more mindful engage in more patient-centered communication and have more satisfied patients. Interventions should determine whether improving clinician mindfulness can also improve patient health outcomes.
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Previous studies found that stress, depression, burnout, anxiety, and depersonalisation play a significant role amongst dental and medical students. We wanted to examine if students of the University of Erlangen-Nuremberg also would report elevated values as can been found in similar publications. Furthermore, particularly coping strategies were investigated. The data collection took place in April 2008 including 182 dental and medical students of the 4th and 5th academic year at the University of Erlangen-Nuremberg. Demographic data and the following screening instruments were used: Maslach Burnout Inventory (MBI), Cambridge Depersonalisation Scale (CDS-9), Hospital Anxiety and Depression Scale (HADS), Brief COPE. Descriptive statistics showed higher pathological values in dental students than in medical students. The difference was especially pronounced on the depersonalisation scale (CDS-9), with 20.4% of the dental students, but only 5.5% of the medical students showing scores above a cut-off of 19. The scores decreased in the course of 3 semesters of dentistry. The students with elevated values showed a higher degree of dysfunctional coping. Our results obtained with the screening instruments are in line with the results of previous investigations of other authors and point out the importance of this issue. It might be useful to develop programs teaching dental students more adaptive coping strategies before their first patient contact.
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A significant proportion of physicians and medical trainees experience stress-related anxiety and burnout resulting in increased absenteeism and disability, decreased patient satisfaction, and increased rates of medical errors. A review and meta-analysis was conducted to examine the effectiveness of interventions aimed at addressing stress, anxiety, and burnout in physicians and medical trainees. Twelve studies involving 1034 participants were included in three meta-analyses. Cognitive, behavioral, and mindfulness interventions were associated with decreased symptoms of anxiety in physicians (standard differences in means [SDM], -1.07; 95% confidence interval [CI], -1.39 to -0.74) and medical students (SDM, -0.55; 95% CI, -0.74 to -0.36). Interventions incorporating psychoeducation, interpersonal communication, and mindfulness meditation were associated with decreased burnout in physicians (SDM, -0.38; 95% CI, -0.49 to -0.26). Results from this review and meta-analysis provide support that cognitive, behavioral, and mindfulness-based approaches are effective in reducing stress in medical students and practicing physicians. There is emerging evidence that these models may also contribute to lower levels of burnout in physicians.
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Context: Workplace stress and burnout are pervasive problems, affecting employee performance and personal health. Objective: To evaluate the effects of the Transcendental Meditation program on psychological distress and burnout among staff at a residential therapeutic school for students with severe behavioral problems. Design: A total of 40 secondary schoolteachers and support staff at the Bennington School in Vermont, a therapeutic school for children with behavioral problems, were randomly assigned to either practice of the Transcendental Meditation program or a wait-list control group. The Transcendental Meditation course was provided by certified instructors. Main outcome measures: Outcome measures were assessed at baseline and four months, and included perceived stress, depression, and burnout. A multivariate analysis of covariance was used to determine overall effects. Results: Analysis of the 4-month intervention data indicated a significant improvement in the main outcomes of the study resulting from practice of the Transcendental Meditation program compared with controls (Wilks Λ [3,28] = 0.695; p = 0.019). Results of univariate F tests indicated a significant reduction of all main outcome measures: perceived stress (F[1,32] = 13.42; p = < 0.001); depression (F[1,32] = 6.92; p = 0.013); and overall teacher burnout (F[1,32] = 6.18; p = 0.018). Effect sizes ranged from 0.40 to 0.94. Conclusions: The Transcendental Meditation program was effective in reducing psychological distress in teachers and support staff working in a therapeutic school for students with behavioral problems. These findings have important implications for employees’ job performance as well as their mental and physical health.
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Mindfulness-based cognitive therapy (MBCT) is an efficacious psychosocial intervention for recurrent depression (Kuyken et al., 2008, Ma and Teasdale, 2004 and Teasdale et al., 2000). To date, no compelling research addresses MBCT’s mechanisms of change. This study determines whether MBCT’s treatment effects are mediated by enhancement of mindfulness and self-compassion across treatment, and/or by alterations in post-treatment cognitive reactivity. The study was embedded in a randomized controlled trial comparing MBCT with maintenance antidepressants (mADM) with 15-month follow-up (Kuyken et al., 2008). Mindfulness and self-compassion were assessed before and after MBCT treatment (or at equivalent time points in the mADM group). Post-treatment reactivity was assessed one month after the MBCT group sessions or at the equivalent time point in the mADM group. One hundred and twenty-three patients with ≥3 prior depressive episodes, and successfully treated with antidepressants, were randomized either to mADM or MBCT. The MBCT arm involved participation in MBCT, a group-based psychosocial intervention that teaches mindfulness skills, and discontinuation of ADM. The mADM arm involved maintenance on a therapeutic ADM dose for the duration of follow-up. Interviewer-administered outcome measures assessed depressive symptoms and relapse/recurrence across 15-month follow-up. Mindfulness and self-compassion were measured using self-report questionnaire. Cognitive reactivity was operationalized as change in depressive thinking during a laboratory mood induction.