- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02887300
Mantra Meditation to Reduce Emotional Exhaustion in Emergency Department Staff
Feasibility Pilot Study to Examine the Role of Mantra Meditation at Reducing Burn Out and Emotional Exhaustion in Emergency Department Staff
Work in a healthcare setting, such as in an emergency department (ED), while rewarding, can be harmful to psychological well being, as demonstrated by the high numbers of Irish hospital doctors experiencing burnout. Burnout has been linked to poor healthcare quality, medical errors and low patient satisfaction. To prevent further escalation of this problem, there is a need for effective stress-reducing intervention, such as meditation. Meditation practice has a confirmed positive effect on well being; through greater insight and awareness, meditation could help ED staff to become more attentive to and understanding of their patients' complaints, enhancing patient satisfaction and safety. However, based on current research it is difficult to distinguish between the effects of meditation on well being and those associated with bringing people together. There is therefore a need for a larger randomised study (RCT) including a participants that receive no meditation intervention.
This pilot study aims to examine the suitability of RCT to assess the effect of mantra meditation on burnout among ED staff. The investigators will also examine participant recruitment and retention, data management and outcomes assessment methods for well being, patient satisfaction and biological markers. There will be two groups: intervention group (meditation) and control group (non-meditation). 30 ED staff placed in the intervention group will discuss prescribed texts and learn mantra meditation over a 7-week period, accompanied by 20 minutes of daily meditation practice. 30 ED staff placed in the control group will work in the ED as usual and not receive any texts. Biological samples and questionnaires will be obtained at three time points. Participant feedback will also be sought through interviews. This study will highlight issues related to participant recruitment, retention, and adherence, questionnaires, logistics, and data management and pave the way for an efficient, effective, and larger study that will investigate mantra meditation as a means of reducing burnout in ED staff.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Dublin, Ireland, 0008
- Trinity Health Centre, Centre for Learning and development, SJH
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Staff member (nurse or doctor) of the ED department of St. James' hospital, Dublin
- Preference to participate in the study
Strict inclusion criteria will be applied for admitted ED patients (determined by the Clinical Research Facility data controller and ward staff):
- Conscious patient
- Cognitively functioning to an adequate level
- Not actively abusing any substance
- Preference to participate
- Over the age of 18 years
Exclusion Criteria:
- Alcohol or substance abuse within the past 6 months
- Are currently using (at the time of enrolment) anti-psychotic medication or recently started on anti-depressant medication (less than 3 months at the time of enrolment). Participants on a stable dose of anti-depressant medication (for more than 3 months) will be permitted but advised to consult with their GP or psychiatrist prior to enrolment.
- A diagnosis of schizophrenia
- More than 4 consecutive classes of meditation training or mind-body practices (including yoga and tai-chi) in the past 2 years
- Current pregnancy or lactation
- Not available to attend all programme dates
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Passive control group
After randomisation, 30 consenting, eligible study participants will be allotted a place in the passive, parallel control group. Participants will work as usual in the ED. Biological and survey samples will be obtained from both groups of participants on the same days: T1 - one week before session one T2 - one week after session 4 T3 - three months following T2 |
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Experimental: Planned intervention - mantra meditation
After randomisation, 30 randomly chosen, ED staff members will be taught mantra meditation by an experienced meditator. Each 4 hour session will occur once every two weeks for 8 weeks (total of 4 sessions) and consist of guided meditation as well as discussions around prescribed texts on the meaning of health care. In addition, participants will be asked to engage in home work (20 minutes of a guided mantra meditation on a twice daily basis). Biological and survey samples will be obtained from both groups of participants on the same days: T1 - one week before session one T2 - one week after session 4 T3 - three months following T2 |
Week 1: 20 minute meditation session. Prescribed text discussion. Encouraging a daily practice; the log, daily readings, timer etc. Week 2: Review of the practice followed by a 20 minute meditation period. Challenges to learning meditation. Second 20 minute meditation. Discussion of prescribed text. Week 3: 20 minute meditation. Review of Atul Gawande's lecture. Second 20 minute period of meditation. Discussion of prescribed text. Week 4: 20 minute meditation session. Discussion of prescribed text. A second 20 minute meditation. End of programme review. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in ED staff burn out using the Maslach Burnout Inventory (MBI)
Time Frame: Week 8 and 20
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Week 8 and 20
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in retention and adherence of consenting participants to both arms of the study
Time Frame: Week 8 and 20
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Week 8 and 20
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Change from baseline in ED staff anxiety and depression using the Depression, Anxiety and Stress Scale (DASS)
Time Frame: Week 8 and 20
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Week 8 and 20
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Change from baseline in ED staff response to meditation using the Five Facets Mindfulness Scale (FFMS) at week 8 and 20
Time Frame: Week 8 and 20
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Week 8 and 20
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Change from baseline in ED staff professional quality of life using the Professional Quality of Life Scale (PQoLS)
Time Frame: Week 8 and 20
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Week 8 and 20
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Change from baseline in participant 24 h ambulatory blood pressure
Time Frame: Week 8
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Week 8
|
Change from baseline in participant heart rate using Fitbit device
Time Frame: Week 8
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Week 8
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Change from baseline in participant salivary cortisol using ELISA on week 8
Time Frame: Week 8
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Week 8
|
Number of participants in the intervention group adhering to home meditation practice using a bespoke application linked to a Fitbit device.
Time Frame: Week 8
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Week 8
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Participant feedback on intervention through qualitative structured interviews
Time Frame: Week 20
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Week 20
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Barry White, MD, University of Dublin, Trinity College
Publications and helpful links
General Publications
- Carlson LE, Speca M, Faris P, Patel KD. One year pre-post intervention follow-up of psychological, immune, endocrine and blood pressure outcomes of mindfulness-based stress reduction (MBSR) in breast and prostate cancer outpatients. Brain Behav Immun. 2007 Nov;21(8):1038-49. doi: 10.1016/j.bbi.2007.04.002. Epub 2007 May 22.
- Beach MC, Roter D, Korthuis PT, Epstein RM, Sharp V, Ratanawongsa N, Cohn J, Eggly S, Sankar A, Moore RD, Saha S. A multicenter study of physician mindfulness and health care quality. Ann Fam Med. 2013 Sep-Oct;11(5):421-8. doi: 10.1370/afm.1507.
- Hayes B, Fitzgerald D, Doherty S, Walsh G. Quality care, public perception and quick-fix service management: a Delphi study on stressors of hospital doctors in Ireland. BMJ Open. 2015 Dec 23;5(12):e009564. doi: 10.1136/bmjopen-2015-009564.
- Prinz P, Hertrich K, Hirschfelder U, de Zwaan M. Burnout, depression and depersonalisation--psychological factors and coping strategies in dental and medical students. GMS Z Med Ausbild. 2012;29(1):Doc10. doi: 10.3205/zma000780. Epub 2012 Feb 15.
- Amtul Z, Arena A, Hirjee H, Khan ZU, Maldeniya PM, Newman RI, Burhan AM, Wetmore S, Vasudev A. A randomized controlled longitudinal naturalistic trial testing the effects of automatic self transcending meditation on heart rate variability in late life depression: study protocol. BMC Complement Altern Med. 2014 Aug 19;14:307. doi: 10.1186/1472-6882-14-307.
- Nieuwenhuijsen K, de Boer AG, Verbeek JH, Blonk RW, van Dijk FJ. The Depression Anxiety Stress Scales (DASS): detecting anxiety disorder and depression in employees absent from work because of mental health problems. Occup Environ Med. 2003 Jun;60 Suppl 1(Suppl 1):i77-82. doi: 10.1136/oem.60.suppl_1.i77.
- Ryan M, Gerard K. Using discrete choice experiments to value health care programmes: current practice and future research reflections. Appl Health Econ Health Policy. 2003;2(1):55-64.
- Dunne PJ, Lynch J, Prihodova L, O'Leary C, Ghoreyshi A, Basdeo SA, Cox DJ, Breen R, Sheikhi A, Carroll A, Walsh C, McMahon G, White B. Burnout in the emergency department: Randomized controlled trial of an attention-based training program. J Integr Med. 2019 May;17(3):173-180. doi: 10.1016/j.joim.2019.03.009. Epub 2019 Mar 29.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- StJamesH
- RCPI (Other Identifier: Royal College of Physicians in Ireland)
- TCD (Other Identifier: Trinity College Dublin)
- HSE (Other Identifier: Health Service Executive of Ireland)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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