Effects of Meditation on Sleep Quality of Medical Students

NCT ID: NCT06342817

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-18
• Study Completion Date: 2024-06-30

Brief Summary

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

Detailed 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)

Conditions

Sleep Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

online mindfulness based meditation program

Intervention Type: BEHAVIORAL

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.

control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

online mindfulness based meditation program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal da Fronteira Sul

OTHER

Sponsor Role: lead

Responsible Party

Tiago Teixeira Simon

Tiago Teixeira Simon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tiago T Simon

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal da Fronteira Sul

Locations

Universidade Federal Da Fronteira Sul

Passo Fundo, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Tiago T Simon, MD

Role: CONTACT

tiago.teixeira@uffs.edu.br

+5554991843384

Facility Contacts

Tiago T Simon, MD

Role: primary

tiago.teixeira@uffs.edu.br

+5554991843384

References

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Reference Type: BACKGROUND

PMID: 25515274 (View on PubMed)

BARROS, V. V. DE et al. Validity evidence of the brazilian version of the Mindful Attention Awareness Scale (MAAS). Psicologia: Reflexão e Crítica, v. 28, n. 1, p. 87-95, mar. 2015.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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CAMPOS, J. A. D. B.; CARLOTTO, M. S.; MARÔCO, J. Copenhagen Burnout Inventory - student version: adaptation and transcultural validation for Portugal and Brazil. Psicologia: Reflexão e Crítica, v. 26, n. 1, p. 87-97, 2013.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 31743957 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 34297230 (View on PubMed)

Ong JC, Moore C. What do we really know about mindfulness and sleep health? Curr Opin Psychol. 2020 Aug;34:18-22. doi: 10.1016/j.copsyc.2019.08.020. Epub 2019 Aug 24.

Reference Type: BACKGROUND

PMID: 31539830 (View on PubMed)

Rusch HL, Rosario M, Levison LM, Olivera A, Livingston WS, Wu T, Gill JM. The effect of mindfulness meditation on sleep quality: a systematic review and meta-analysis of randomized controlled trials. Ann N Y Acad Sci. 2019 Jun;1445(1):5-16. doi: 10.1111/nyas.13996. Epub 2018 Dec 21.

Reference Type: BACKGROUND

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Vignola RC, Tucci AM. Adaptation and validation of the depression, anxiety and stress scale (DASS) to Brazilian Portuguese. J Affect Disord. 2014 Feb;155:104-9. doi: 10.1016/j.jad.2013.10.031. Epub 2013 Oct 28.

Reference Type: BACKGROUND

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Study Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UFFS

Identifier Type: -

Identifier Source: org_study_id