search
Back to results

Impact of Teaching "Meditation Techniques" on the Mental Health and Quality of Life of Medical Students

Primary Purpose

Stress, Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mindfulness training
Sponsored by
Federal University of Juiz de Fora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress focused on measuring stress, anxiety, depression, quality of life, Mindfulness

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • First year medical students who agree to participate in the study and are officially registered in the mindfulness course at the school of medicine - Federal University of Juiz de Fora, Brazil

Exclusion criteria:

  • Students who refused to participate

Sites / Locations

  • Federal University of Juiz de Fora

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Early Mindfulness exposure

Late Mindfulness exposure

Control (not exposed)

Arm Description

six weeks of 2 hours class of mindfulness training and orientations for home training at the beginning of the first semester

six weeks of 2 hours class of mindfulness training and orientations for home training at the second half of the first semester

Students not exposed to the mindfulness mandatory course (not exposed to the intervention)

Outcomes

Primary Outcome Measures

Assess emotional states of depression, anxiety and stress.
DASS 21 questionnaire application
Assess emotional states of depression, anxiety and stress.
DASS 21 questionnaire application
Assess emotional states of depression, anxiety and stress.
DASS 21 questionnaire application

Secondary Outcome Measures

Assess general facet of "quality of life" and "health"
WHOQOL-BREF questionnaire application
Assess general facet of "quality of life" and "health"
WHOQOL-BREF questionnaire application
Assess general facet of "quality of life" and "health"
WHOQOL-BREF questionnaire application
Evaluation of empathy, spirituality openness and wellness
ESWIM questionnaire application
Evaluation of empathy, spirituality openness and wellness
ESWIM questionnaire application
Evaluation of empathy, spirituality openness and wellness
ESWIM questionnaire application

Full Information

First Posted
April 20, 2017
Last Updated
February 14, 2019
Sponsor
Federal University of Juiz de Fora
search

1. Study Identification

Unique Protocol Identification Number
NCT03132597
Brief Title
Impact of Teaching "Meditation Techniques" on the Mental Health and Quality of Life of Medical Students
Official Title
Impact of Teaching "Meditation Techniques" on the Mental Health and Quality of Life of Medical Students
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal University of Juiz de Fora

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Studies show a high number of medical students suffering from mental health problems. Although there are several studies investigating how these problems could impact students' life and performance, few studies have investigated interventions to minimize this distress. One of these interventions is the mindfulness meditation, that has already been extensively studied in the scientific literature showing promising results. Nevertheless, there are very few studies which investigated how mindfulness could be implemented as a mandatory course. The present study aims to investigate (1) how students exposed to mindfulness differ from students not exposed to this technique concerning their mental health and quality of life in a short and long term period. This is an intervention protocol using a randomized controlled clinical trial with cross-over, in order to compare if the implementation of mindfulness for first year medical students will improve their mental health and quality of life in the short term (3 months). The intervention group (group 1) will be exposed to mindfulness in the beginning of the medical course and will be compared to a control group (group 2), not exposed to mindfulness (exposed to theoretical classes) for 3 months. After that, the intervention group (group 1) will receive theoretical classes and the control group (group 2) will be exposed to the mindfulness techniques for 3 months (cross-over). Therefore, both groups will be exposed to mindfulness in the first year of undergraduation, however in different moments of the course. Then, these first year medical students (groups 1 and 2) will be compared to another class (group 3), which didn't have this mindfulness mandatory course in their formation. They will be compared after 6 months, 12 and 24 months of intervention (long-term effect).
Detailed Description
Studies show a high number of medical students suffering from mental health problems. Although there are several studies investigating how these problems could impact students' life and performance, few studies have investigated interventions to minimize this distress. One of these interventions is the mindfulness meditation, that has already been extensively studied in the scientific literature showing promising results. Nevertheless, there are very few studies which investigated how mindfulness could be implemented as a mandatory course. The present study aims to investigate how students exposed to mindfulness differ from students not exposed to this technique concerning their mental health and quality of life in a short and long term period. Design: This is an intervention protocol using a randomized controlled clinical trial with cross-over, in order to compare if the implementation of mindfulness for first year medical students will improve their mental health and quality of life in the short term (3 months). The intervention group (group 1) will be exposed to mindfulness in the beginning of the medical course and will be compared to a control group (group 2), not exposed to mindfulness (exposed to theoretical classes) for 3 months. After that, the intervention group (group 1) will receive theoretical classes and the control group (group 2) will be exposed to the mindfulness techniques for 3 months (cross-over). Therefore, both groups (groups 1 and 2) will be exposed to mindfulness in the first year of undergraduation, however in different moments of the course. Then, all first year medical students exposed to mindfulness (groups 1 and 2) will be compared to another class, which didn't have this mindfulness mandatory course in their formation (group 3). They will be compared after 6 months and after one-year of intervention (long-term effect). Interventions: Mindfulness techniques will be delivered to students for a period of six weeks. In these six weeks the following techniques are presented and trained: body scan, mindful eating, breath meditation, listen mindfully, walking meditation, mountain meditation, compassion meditation, observation thoughts as just thoughts, awareness with listing of daily activities, mindful breath mini-breaks and some breath exercises. Theoretical classes will provide tools in order to help students to deal with their medical school entrance, including how the medical school and the university works (library, evaluations, being a doctor, scholarships and student aid work, among others) and what students should know about their career as future physicians. Procedures: Students will answer the questionnaire in the following way: Intervention Group: before intervention (baseline), after intervention (3 months), after cross-over (6 months), 12 months and 24 months. Control Group: before intervention (baseline), before intervention (3 months), after intervention - cross over (6 months), 12 months and 24 months. Class not exposed to mindfulness mandatory course: 12 months and 24 months Instruments: The following instruments will be used: DASS-21: Depression, anxiety and stress scale Quality of Life: WHOQOL-Bref scale FFMQ: Five facet mindfulness questionnaire Sociodemographic data Statistical analysis: Students will be compared in the following way: Students exposed to mindfulness versus students not exposed = short term period (3 months) Students with an early exposition to mindfulness in the first year versus students with a later exposition = short term period (6 months) Students exposed to a mandatory course on mindfulness versus students not exposed to this course = long term period (12 and 24 months)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anxiety, Depression, Quality of Life
Keywords
stress, anxiety, depression, quality of life, Mindfulness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is an intervention protocol using a randomized controlled clinical trial with cross-over, in order to compare if the implementation of mindfulness for first year medical students will improve their mental health and quality of life in the short term (3 months). The intervention group will be exposed to mindfulness in the beginning of the medical course and will be compared to a control group, not exposed to mindfulness (exposed to theoretical classes) for 3 months. After that, the intervention group will receive theoretical classes and the control group will be exposed to the mindfulness techniques for 3 months (cross-over). Therefore, both groups will be exposed to mindfulness in the first year of undergraduation. Then, all first year medical students exposed to mindfulness will be compared to another class, which didn't have this mindfulness mandatory course in their formation. They will be compared after 6 months and after one-year of intervention (long-term effect).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Mindfulness exposure
Arm Type
Experimental
Arm Description
six weeks of 2 hours class of mindfulness training and orientations for home training at the beginning of the first semester
Arm Title
Late Mindfulness exposure
Arm Type
Experimental
Arm Description
six weeks of 2 hours class of mindfulness training and orientations for home training at the second half of the first semester
Arm Title
Control (not exposed)
Arm Type
No Intervention
Arm Description
Students not exposed to the mindfulness mandatory course (not exposed to the intervention)
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness training
Intervention Description
six weeks of 2 hours class of mindfulness training and orientations for home training
Primary Outcome Measure Information:
Title
Assess emotional states of depression, anxiety and stress.
Description
DASS 21 questionnaire application
Time Frame
At 3 months
Title
Assess emotional states of depression, anxiety and stress.
Description
DASS 21 questionnaire application
Time Frame
At 6 months
Title
Assess emotional states of depression, anxiety and stress.
Description
DASS 21 questionnaire application
Time Frame
At 24 months
Secondary Outcome Measure Information:
Title
Assess general facet of "quality of life" and "health"
Description
WHOQOL-BREF questionnaire application
Time Frame
At 3 months
Title
Assess general facet of "quality of life" and "health"
Description
WHOQOL-BREF questionnaire application
Time Frame
At 6 months
Title
Assess general facet of "quality of life" and "health"
Description
WHOQOL-BREF questionnaire application
Time Frame
At 24 months
Title
Evaluation of empathy, spirituality openness and wellness
Description
ESWIM questionnaire application
Time Frame
At 3 months
Title
Evaluation of empathy, spirituality openness and wellness
Description
ESWIM questionnaire application
Time Frame
At 6 months
Title
Evaluation of empathy, spirituality openness and wellness
Description
ESWIM questionnaire application
Time Frame
At 24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: First year medical students who agree to participate in the study and are officially registered in the mindfulness course at the school of medicine - Federal University of Juiz de Fora, Brazil Exclusion criteria: Students who refused to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscarina S Ezequiel, MD, PhD
Organizational Affiliation
Federal University of Juiz de Fora
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Juiz de Fora
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36038330
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23823667
Citation
Barbosa P, Raymond G, Zlotnick C, Wilk J, Toomey R 3rd, Mitchell J 3rd. Mindfulness-based stress reduction training is associated with greater empathy and reduced anxiety for graduate healthcare students. Educ Health (Abingdon). 2013 Jan-Apr;26(1):9-14. doi: 10.4103/1357-6283.112794.
Results Reference
background
PubMed Identifier
23941053
Citation
de Vibe M, Solhaug I, Tyssen R, Friborg O, Rosenvinge JH, Sorlie T, Bjorndal A. Mindfulness training for stress management: a randomised controlled study of medical and psychology students. BMC Med Educ. 2013 Aug 13;13:107. doi: 10.1186/1472-6920-13-107.
Results Reference
background
PubMed Identifier
24607079
Citation
Demarzo MM, Andreoni S, Sanches N, Perez S, Fortes S, Garcia-Campayo J. Mindfulness-based stress reduction (MBSR) in perceived stress and quality of life: an open, uncontrolled study in a Brazilian healthy sample. Explore (NY). 2014 Mar-Apr;10(2):118-20. doi: 10.1016/j.explore.2013.12.005. Epub 2013 Dec 18. No abstract available.
Results Reference
background
PubMed Identifier
23837423
Citation
Dobkin PL, Hutchinson TA. Teaching mindfulness in medical school: where are we now and where are we going? Med Educ. 2013 Aug;47(8):768-79. doi: 10.1111/medu.12200.
Results Reference
background
PubMed Identifier
16565188
Citation
Dyrbye LN, Thomas MR, Shanafelt TD. Systematic review of depression, anxiety, and other indicators of psychological distress among U.S. and Canadian medical students. Acad Med. 2006 Apr;81(4):354-73. doi: 10.1097/00001888-200604000-00009.
Results Reference
background
PubMed Identifier
21099385
Citation
Ghodasara SL, Davidson MA, Reich MS, Savoie CV, Rodgers SM. Assessing student mental health at the Vanderbilt University School of Medicine. Acad Med. 2011 Jan;86(1):116-21. doi: 10.1097/ACM.0b013e3181ffb056.
Results Reference
background
PubMed Identifier
24395196
Citation
Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.
Results Reference
background
PubMed Identifier
25792145
Citation
Greeson JM, Toohey MJ, Pearce MJ. An adapted, four-week mind-body skills group for medical students: reducing stress, increasing mindfulness, and enhancing self-care. Explore (NY). 2015 May-Jun;11(3):186-92. doi: 10.1016/j.explore.2015.02.003. Epub 2015 Feb 16.
Results Reference
background
PubMed Identifier
15256293
Citation
Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. doi: 10.1016/S0022-3999(03)00573-7.
Results Reference
background
PubMed Identifier
19707055
Citation
Hojat M, Vergare MJ, Maxwell K, Brainard G, Herrine SK, Isenberg GA, Veloski J, Gonnella JS. The devil is in the third year: a longitudinal study of erosion of empathy in medical school. Acad Med. 2009 Sep;84(9):1182-91. doi: 10.1097/ACM.0b013e3181b17e55. Erratum In: Acad Med. 2009 Nov;84(11):1616.
Results Reference
background
PubMed Identifier
24016170
Citation
Jamali A, Tofangchiha S, Jamali R, Nedjat S, Jan D, Narimani A, Montazeri A. Medical students' health-related quality of life: roles of social and behavioural factors. Med Educ. 2013 Oct;47(10):1001-12. doi: 10.1111/medu.12247.
Results Reference
background
Citation
KABAT-ZINN, J. Full catastrophe living: Using the wisdom of your body and mind to face stress, pain and illness. New York: Delacorte, 1990.
Results Reference
background
PubMed Identifier
25818837
Citation
Khoury B, Sharma M, Rush SE, Fournier C. Mindfulness-based stress reduction for healthy individuals: A meta-analysis. J Psychosom Res. 2015 Jun;78(6):519-28. doi: 10.1016/j.jpsychores.2015.03.009. Epub 2015 Mar 20.
Results Reference
background
PubMed Identifier
25887430
Citation
Kuhlmann SM, Burger A, Esser G, Hammerle F. A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial. Trials. 2015 Feb 8;16:40. doi: 10.1186/s13063-014-0533-9.
Results Reference
background
PubMed Identifier
26860797
Citation
Lamothe M, Rondeau E, Malboeuf-Hurtubise C, Duval M, Sultan S. Outcomes of MBSR or MBSR-based interventions in health care providers: A systematic review with a focus on empathy and emotional competencies. Complement Ther Med. 2016 Feb;24:19-28. doi: 10.1016/j.ctim.2015.11.001. Epub 2015 Nov 27.
Results Reference
background
PubMed Identifier
24556765
Citation
Slavin SJ, Schindler DL, Chibnall JT. Medical student mental health 3.0: improving student wellness through curricular changes. Acad Med. 2014 Apr;89(4):573-7. doi: 10.1097/ACM.0000000000000166.
Results Reference
background
PubMed Identifier
23126332
Citation
Tempski P, Bellodi PL, Paro HB, Enns SC, Martins MA, Schraiber LB. What do medical students think about their quality of life? A qualitative study. BMC Med Educ. 2012 Nov 5;12:106. doi: 10.1186/1472-6920-12-106.
Results Reference
background
PubMed Identifier
25888726
Citation
van Dijk I, Lucassen PL, Speckens AE. Mindfulness training for medical students in their clinical clerkships: two cross-sectional studies exploring interest and participation. BMC Med Educ. 2015 Feb 25;15:24. doi: 10.1186/s12909-015-0302-9.
Results Reference
background
PubMed Identifier
21401686
Citation
Warnecke E, Quinn S, Ogden K, Towle N, Nelson MR. A randomised controlled trial of the effects of mindfulness practice on medical student stress levels. Med Educ. 2011 Apr;45(4):381-8. doi: 10.1111/j.1365-2923.2010.03877.x.
Results Reference
background
PubMed Identifier
25034955
Citation
Williams D, Tricomi G, Gupta J, Janise A. Efficacy of burnout interventions in the medical education pipeline. Acad Psychiatry. 2015 Feb;39(1):47-54. doi: 10.1007/s40596-014-0197-5. Epub 2014 Jul 18.
Results Reference
background
PubMed Identifier
28225885
Citation
Moutinho IL, Maddalena NC, Roland RK, Lucchetti AL, Tibirica SH, Ezequiel OD, Lucchetti G. Depression, stress and anxiety in medical students: A cross-sectional comparison between students from different semesters. Rev Assoc Med Bras (1992). 2017 Jan 1;63(1):21-28. doi: 10.1590/1806-9282.63.01.21.
Results Reference
background
PubMed Identifier
31452038
Citation
Damiao Neto A, Lucchetti ALG, da Silva Ezequiel O, Lucchetti G. Effects of a Required Large-Group Mindfulness Meditation Course on First-Year Medical Students' Mental Health and Quality of Life: a Randomized Controlled Trial. J Gen Intern Med. 2020 Mar;35(3):672-678. doi: 10.1007/s11606-019-05284-0. Epub 2019 Aug 26.
Results Reference
derived

Learn more about this trial

Impact of Teaching "Meditation Techniques" on the Mental Health and Quality of Life of Medical Students

We'll reach out to this number within 24 hrs