NCT02887300

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

January 31, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

5 months

First QC Date

August 24, 2016

Last Update Submit

February 13, 2017

Conditions

Keywords

Quality of Health CarePsychological StressBurnoutHealth Care ProfessionalMantra MeditationHealth Care Economics

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in ED staff burn out using the Maslach Burnout Inventory (MBI)

    Week 8 and 20

Secondary Outcomes (9)

  • Change from baseline in retention and adherence of consenting participants to both arms of the study

    Week 8 and 20

  • Change from baseline in ED staff anxiety and depression using the Depression, Anxiety and Stress Scale (DASS)

    Week 8 and 20

  • Change from baseline in ED staff response to meditation using the Five Facets Mindfulness Scale (FFMS) at week 8 and 20

    Week 8 and 20

  • Change from baseline in ED staff professional quality of life using the Professional Quality of Life Scale (PQoLS)

    Week 8 and 20

  • Change from baseline in participant 24 h ambulatory blood pressure

    Week 8

  • +4 more secondary outcomes

Study Arms (2)

Passive control group

NO INTERVENTION

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

Planned intervention - mantra meditation

EXPERIMENTAL

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

Behavioral: Mantra Meditation

Interventions

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.

Planned intervention - mantra meditation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Staff member (nurse or doctor) of the ED department of St. James' hospital, Dublin
  • Preference to participate in the study
  • Conscious patient
  • Cognitively functioning to an adequate level
  • Not actively abusing any substance
  • Preference to participate
  • Over the age of 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trinity Health Centre, Centre for Learning and development, SJH

Dublin, Dublin, 0008, Ireland

Location

Related Publications (8)

  • 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.

    PMID: 26700286BACKGROUND
  • 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.

    PMID: 22403595BACKGROUND
  • 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.

    PMID: 25134497BACKGROUND
  • 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.

    PMID: 24019273BACKGROUND
  • 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.

    PMID: 12782751BACKGROUND
  • 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.

    PMID: 17521871BACKGROUND
  • 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.

    PMID: 14619274BACKGROUND
  • 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.

MeSH Terms

Conditions

Stress, PsychologicalBurnout, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Barry White, MD

    University of Dublin, Trinity College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

August 24, 2016

First Posted

September 2, 2016

Study Start

January 31, 2017

Primary Completion

June 23, 2017

Study Completion

December 1, 2017

Last Updated

February 14, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

Patient identity will be coded by a designated data controller from the Wellcome/Health Research Board Clinical Research Facility, St James' Hospital. Therefore, only individual participant data in the form of coded data will be shared via academic publications only.

Locations