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Effects of Meditation on Sleep Quality of Medical Students

U

Universidade Federal da Fronteira Sul

Status

Enrolling

Conditions

Sleep Disorder

Treatments

Behavioral: online mindfulness based meditation program

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The objective of the study is to evaluate the effect of an 8-week online mindfulness-based meditation program on quality sleep status of undergraduate students medicine in the city of Passo Fundo/RS and Chapecó/SC In addition to sleep quality, secondary outcomes such as mindfulness, symptoms of depression, stress, anxiety and burnout will also be assessed

Full description

A controlled, single-center, randomized parallel group clinical trial will be developed to evaluate the effectiveness of an online mindfulness-based meditation program (POMBM) on the quality of sleep of medical students. The trial expects to involve 136 participants who will be randomized 1:1 into the intervention group or a waiting group (which will be called the control group), with 68 expected participants each. All trial procedures will take place online via Google meet and will consist of an invitation and presentation of the study, followed by an initial screening visit for those interested, and an intervention period of 8 weeks. The POMBM will be administered weekly online during the intervention period, with each session lasting 45 to 60 minutes. The control group will not perform any activities during the intervention period. Participants in both groups will be evaluated at the initial visit (T0), in the fifth week (T1), immediately after the end of the intervention period (T2) and in a 2-month follow-up after the end of the program (T3) using the following instruments : PSQI (Pittsburgh Quality Sleep Index), ESE (Epworth Sleepiness Scale), MAAS (Mindful Attention Awareness Scale), DASS-21 (Depression, Anxiety and Stress Scale), and CBI-S (Copenhagen Burnout Inventory Student Version)

Enrollment

136 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Interest in participating in the study; over 18 years old; both genders; being duly registered in the Medicine course at Passo Fundo or Chapecó's faculties, from the 1st to 12th phase of the course

Exclusion criteria

  • Have participated in another course or workshop on meditation in the last 4 weeks in addition to the invitation to study; being an active practitioner of meditation, yoga, tai-chi, qui-gong (at least 6 months before the start of the study); previous medical diagnosis of cognitive, language or communication deficits; alcohol dependence and other chemical substances; previous medical diagnosis of a disorder with risk of suicide or attempt of previous suicide; previous medical diagnosis of post-traumatic stress disorder; previous medical diagnosis of depressive disorder currently untreated; previous medical diagnosis of schizophrenia or delusional/hallucinatory disorders; previous medical diagnosis of social anxiety (difficulty being in a classroom)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

136 participants in 2 patient groups

Intervention
Experimental group
Description:
Participants in the intervention group will attend 8 weekly online meetings lasting approximately 60 minutes each (generally structured in an initial 10 minutes for questions about the practices, 15-20 minutes of exposition on the central theme of the meeting, 5-10 minutes for class practice, 10-15 minutes for post-practice inquiry, 5 minutes for explanation of the week's informal practice and audios for daily practice). Audio in mp3 of the practice carried out at each meeting will be provided to maintain daily individual practice during the week. An online questionnaire related to weekly practices will also be left at the beginning of each meeting.
Treatment:
Behavioral: online mindfulness based meditation program
control group
No Intervention group
Description:
In the control group there will be no intervention. Participants will only participate in the initial meeting explaining the study design and their role in it, inviting them to complete the questionnaires at the same time as the intervention group. They will commit to not receiving any intervention and will be asked not to participate in any meditation or mindfulness sessions during the period of application of the POMBM to the intervention group (8 weeks). After the end of this period, it will be offered the possibility to take the POMBM as they wish.

Trial contacts and locations

1

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Central trial contact

Tiago T Simon, MD

Data sourced from clinicaltrials.gov

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