Psychological StressNCT02887300
Mantra Meditation to Reduce Emotional Exhaustion in Emergency Department Staff
A study testing Mantra Meditation in people with Psychological Stress, run by St. James's Hospital, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Mantra Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteIreland
- Study dates
- 31 Jan 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Trinity Health Centre, Centre for Learning and development, SJH
Dublin, Dublin, 0008
About this study
Official title: 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.
Read the detailed description
The practice of medicine by health care professionals (HCPs), while often meaningful and rewarding, can have a detrimental effect on mental and physical well-being. Alongside the impact of exposure to environmental hazards, doctors are at above-average risk of developing stress-related psychological morbidities, substance abuse, and dysfunctional interpersonal relationships. 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. This is corroborated by findings from a recent report by the Royal College of Physicians of Ireland (RCPI), which asserts that high percentage of Irish hospital doctors experience increased levels of burnout. Burnout comprises emotional exhaustion, a diminished sense of personal accomplishment, and depersonalisation, which can manifest as cynicism and a lack of empathy. In light of this, burnout among HCPs can have significant implications for the quality of healthcare provided to patients. Indeed, research demonstrates an association between HCP burnout and reduced compassion and empathy, increased medical errors, and decreased patient satisfaction. There is growing evidence indicating the psychological and physiological benefits of mindfulness and meditation in the general population. While less attention has been afforded to the potential gains for physicians and other HCPs, a limited body of research demonstrates the efficacy of mindfulness-based interventions in improving psychological well being and job satisfaction among this population. For example, a recent pilot study conducted by RCPI demonstrates that mantra meditation significantly reduced emotional exhaustion in 19 HCPs. The enhanced insight and awareness gleaned from meditation can translate into considerable gains for HCPs, patients, and the health service. Meditation can enable HCPs to recognise their own limitations and errors, to listen more attentively, and to observe and understand both physiological and behavioural factors at play. This is corroborated by Beach et al. (Annals of Family Medicine. 2013;11(5):421-8), who found that patients were more likely to give high ratings on clinical communication and to report increased overall satisfaction with clinicians who engage in regular mindfulness practices. Encounters with such clinicians were more likely to be characterised by a patient-centred pattern of communication and conversation about psycho-social issues, while there was no association between clinician mindfulness and discussion of biomedical issues. Meditation also has the potential to enhance patient safety, however, a complex and high-risk system such as healthcare requires additional approaches to augmenting safety. Central to situational awareness, in the context of the health system, is the concept of a mindful clinician who is present in the moment and unencumbered by distraction. In recent years, a state of crisis within Irish healthcare developed, with an increase in the migration of doctors, low levels of recruitment, and under-resourced services. Accordingly, Irish healthcare is characterised by the second-highest level of physician emigration in the world and one of the lowest ratios of doctor/per capita in Europe (www.oecd.org/health/health-at-a-glance-19991312.htm). Reasons for the difficulty in retaining qualified Irish doctors include more favourable working conditions and greater career opportunities abroad. Moreover, the quality of healthcare in Ireland is likely to be compromised by long-term absenteeism if HCPs are forced to leave their jobs prematurely. In light of the unprecedented difficulties in Irish healthcare, and considering the association between HCP burnout and increased absenteeism and disability, the pertinence of this research becomes apparent. HCPs are a vital resource for society and their loss as a result of avoidable ill-health is not only damaging to the health service, but a loss to patients and colleagues. Thus, interventions that aim to reduce or prevent burnout and stress-related psychological morbidities in HCPs are urgently required.
- Conditions
- Psychological Stress
- Being tested
- Mantra Meditation
- Keywords
- Quality of Health Care, Psychological Stress, Burnout, Health Care Professional, Mantra Meditation, Health Care Economics
- Medical subject headings
- Stress, Psychological, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mantra MeditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Mantra Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in ED staff burn out using the Maslach Burnout Inventory (MBI)
Measured: Week 8 and 20
Secondary outcomes (9)
Change from baseline in retention and adherence of consenting participants to both arms of the study
Measured: Week 8 and 20
Change from baseline in ED staff anxiety and depression using the Depression, Anxiety and Stress Scale (DASS)
Measured: 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
Measured: Week 8 and 20
Change from baseline in ED staff professional quality of life using the Professional Quality of Life Scale (PQoLS)
Measured: Week 8 and 20
Change from baseline in participant 24 h ambulatory blood pressure
Measured: Week 8
Change from baseline in participant heart rate using Fitbit device
Measured: Week 8
Change from baseline in participant salivary cortisol using ELISA on week 8
Measured: Week 8
Number of participants in the intervention group adhering to home meditation practice using a bespoke application linked to a Fitbit device.
Measured: Week 8
Participant feedback on intervention through qualitative structured interviews
Measured: Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study start31 Jan 2017
- Primary completion23 Jun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Physicians, University of Dublin, Trinity College, Health Service Executive, Ireland
- Responsible party
- Principal investigator, Padraic Dunne, St. James's Hospital, Ireland
- Investigators
- Barry White, MD, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887300
- Sponsor's protocol ID
- StJamesH
- Other IDs
- RCPI, TCD, HSE
- Status last verified
- Feb 2017
- First submitted
- 24 Aug 2016
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 26700286Prinz 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.
PubMed 22403595Amtul 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.
PubMed 25134497Beach 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.
PubMed 24019273Nieuwenhuijsen 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.
PubMed 12782751Carlson 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.
PubMed 17521871Ryan 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.
PubMed 14619274Dunne 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.
PubMed 30956141
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Pilot Study to Examine the Role of Mantra Meditation at Reducing Burn Out and Emotional Exhaustion in Emergency Department Staff
- ClinicalTrials.gov ID
- NCT02887300
- Acronym / sponsor ID
- StJamesH
- Conditions
- Psychological Stress
- Keywords
- Quality of Health Care, Psychological Stress, Burnout, Health Care Professional, Mantra Meditation, Health Care Economics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (actual)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Collaborators
- Royal College of Physicians, University of Dublin, Trinity College, Health Service Executive, Ireland
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 23 Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The practice of medicine by health care professionals (HCPs), while often meaningful and rewarding, can have a detrimental effect on mental and physical well-being. Alongside the impact of exposure to environmental hazards, doctors are at above-average risk of developing stress-related psychological morbidities, substance abuse, and dysfunctional interpersonal relationships. 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. This is corroborated by findings from a recent report by the Royal College of Physicians of Ireland (RCPI), which asserts that high percentage of Irish hospital doctors experience increased levels of burnout. Burnout comprises emotional exhaustion, a diminished sense of personal accomplishment, and depersonalisation, which can manifest as cynicism and a lack of empathy. In light of this, burnout among HCPs can have significant implications for the quality of healthcare provided to patients. Indeed, research demonstrates an association between HCP burnout and reduced compassion and empathy, increased medical errors, and decreased patient satisfaction. There is growing evidence indicating the psychological and physiological benefits of mindfulness and meditation in the general population. While less attention has been afforded to the potential gains for physicians and other HCPs, a limited body of research demonstrates the efficacy of mindfulness-based interventions in improving psychological well being and job satisfaction among this population. For example, a recent pilot study conducted by RCPI demonstrates that mantra meditation significantly reduced emotional exhaustion in 19 HCPs. The enhanced insight and awareness gleaned from meditation can translate into considerable gains for HCPs, patients, and the health service. Meditation can enable HCPs to recognise their own limitations and errors, to listen more attentively, and to observe and understand both physiological and behavioural factors at play. This is corroborated by Beach et al. (Annals of Family Medicine. 2013;11(5):421-8), who found that patients were more likely to give high ratings on clinical communication and to report increased overall satisfaction with clinicians who engage in regular mindfulness practices. Encounters with such clinicians were more likely to be characterised by a patient-centred pattern of communication and conversation about psycho-social issues, while there was no association between clinician mindfulness and discussion of biomedical issues. Meditation also has the potential to enhance patient safety, however, a complex and high-risk system such as healthcare requires additional approaches to augmenting safety. Central to situational awareness, in the context of the health system, is the concept of a mindful clinician who is present in the moment and unencumbered by distraction. In recent years, a state of crisis within Irish healthcare developed, with an increase in the migration of doctors, low levels of recruitment, and under-resourced services. Accordingly, Irish healthcare is characterised by the second-highest level of physician emigration in the world and one of the lowest ratios of doctor/per capita in Europe (www.oecd.org/health/health-at-a-glance-19991312.htm). Reasons for the difficulty in retaining qualified Irish doctors include more favourable working conditions and greater career opportunities abroad. Moreover, the quality of healthcare in Ireland is likely to be compromised by long-term absenteeism if HCPs are forced to leave their jobs prematurely. In light of the unprecedented difficulties in Irish healthcare, and considering the association between HCP burnout and increased absenteeism and disability, the pertinence of this research becomes apparent. HCPs are a vital resource for society and their loss as a result of avoidable ill-health is not only damaging to the health service, but a loss to patients and colleagues. Thus, interventions that aim to reduce or prevent burnout and stress-related psychological morbidities in HCPs are urgently required.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Mantra MeditationAfter 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mantra MeditationWeek 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. | Behavioural | Planned intervention - mantra meditation |
Primary outcome
Change from baseline in ED staff burn out using the Maslach Burnout Inventory (MBI)
Time frame: Week 8 and 20
9 secondary outcomes
Change from baseline in retention and adherence of consenting participants to both arms of the study
Time frame: Week 8 and 20
Change from baseline in ED staff anxiety and depression using the Depression, Anxiety and Stress Scale (DASS)
Time frame: 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
Time frame: Week 8 and 20
Change from baseline in ED staff professional quality of life using the Professional Quality of Life Scale (PQoLS)
Time frame: Week 8 and 20
Change from baseline in participant 24 h ambulatory blood pressure
Time frame: Week 8
Change from baseline in participant heart rate using Fitbit device
Time frame: Week 8
Change from baseline in participant salivary cortisol using ELISA on week 8
Time frame: 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
Participant feedback on intervention through qualitative structured interviews
Time frame: Week 20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Background: PubMed 26700286Hayes 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.
- Background: PubMed 22403595Prinz 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.
- Background: PubMed 25134497Amtul 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.
- Background: PubMed 24019273Beach 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.
- Background: PubMed 12782751Nieuwenhuijsen 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.
- Background: PubMed 17521871Carlson 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.
- Background: PubMed 14619274Ryan 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.
- Derived from this study: PubMed 30956141Dunne 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry White, MD principal investigator
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mantra Meditation in people with Psychological Stress, run by St. James's Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in ED staff burn out using the Maslach Burnout Inventory (MBI) (time frame: Week 8 and 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02887300, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.