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

February 14, 2019 updated by: Federal University of Juiz de Fora
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. Students exposed to mindfulness versus students not exposed = short term period (3 months)
  2. Students with an early exposition to mindfulness in the first year versus students with a later exposition = short term period (6 months)
  3. Students exposed to a mandatory course on mindfulness versus students not exposed to this course = long term period (12 and 24 months)

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36038330
        • Federal University of Juiz de Fora

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Early Mindfulness exposure
six weeks of 2 hours class of mindfulness training and orientations for home training at the beginning of the first semester
Behavioral: Mindfulness training
six weeks of 2 hours class of mindfulness training and orientations for home training
EXPERIMENTAL: Late Mindfulness exposure
six weeks of 2 hours class of mindfulness training and orientations for home training at the second half of the first semester
Behavioral: Mindfulness training
six weeks of 2 hours class of mindfulness training and orientations for home training
NO_INTERVENTION: Control (not exposed)
Students not exposed to the mindfulness mandatory course (not exposed to the intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess emotional states of depression, anxiety and stress.
Time Frame: At 3 months
DASS 21 questionnaire application
At 3 months
Assess emotional states of depression, anxiety and stress.
Time Frame: At 6 months
DASS 21 questionnaire application
At 6 months
Assess emotional states of depression, anxiety and stress.
Time Frame: At 24 months
DASS 21 questionnaire application
At 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess general facet of "quality of life" and "health"
Time Frame: At 3 months
WHOQOL-BREF questionnaire application
At 3 months
Assess general facet of "quality of life" and "health"
Time Frame: At 6 months
WHOQOL-BREF questionnaire application
At 6 months
Assess general facet of "quality of life" and "health"
Time Frame: At 24 months
WHOQOL-BREF questionnaire application
At 24 months
Evaluation of empathy, spirituality openness and wellness
Time Frame: At 3 months
ESWIM questionnaire application
At 3 months
Evaluation of empathy, spirituality openness and wellness
Time Frame: At 6 months
ESWIM questionnaire application
At 6 months
Evaluation of empathy, spirituality openness and wellness
Time Frame: At 24 months
ESWIM questionnaire application
At 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Juiz de Fora

Investigators

  • Study Chair: Oscarina S Ezequiel, MD, PhD, Federal University of Juiz de Fora

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2017

Primary Completion (ACTUAL)

July 31, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

April 20, 2017

First Submitted That Met QC Criteria

April 26, 2017

First Posted (ACTUAL)

April 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61240016.3.0000.5133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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