Clinical trial NCT06342817: Effects of Meditation on Sleep Quality of Medical Students
Official title: Effects of a Meditation Program on the Sleep Quality of Medicine Course Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disorder
Keywords: sleep disorder
Lead sponsor: Universidade Federal da Fronteira Sul
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Those students interested in participating in the study will leave their contact details (telephone and email) to the research coordinator, to whom it will be sent an online questionnaire containing the inclusion and exclusion criteria, and the free consent form through the Google forms platform. Collection instruments will only be made available after fulfilling the inclusion criteria and absence of exclusion criteria and agreement with the consent form. Responders will be randomly randomized 1:1 and subsequently communicated whether they will participate in the intervention group or the control group.
Primary purpose: SUPPORTIVE_CARE

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)

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)

Primary outcomes:
measure: Change in the quality of sleep of medical students on weeks 5, 9 and 17 by the PSQI and ESE
timeFrame: week 0, week 5, week 9 and week 17
Secondary outcomes:
measure: Change in the awareness of medical students on weeks 5, 9 and 17 by the MAAS
timeFrame: week 0, week 5, week 9 and week 17
measure: Change in the depression, anxiety and stress symptoms of medical students on weeks 5, 9 and 17 by the DASS-21
timeFrame: week 0, week 5, week 9 and week 17
measure: Change in the burnout symptoms of medical students on weeks 5, 9 and 17 by CBI-S
timeFrame: week 0, week 5, week 9 and week 17
Other outcomes:
Locations:
city: Passo Fundo
country: Brazil
facility: Universidade Federal Da Fronteira Sul
state: RS
Study officials:
affiliation: Universidade Federal da Fronteira Sul
name: Tiago T Simon
role: PRINCIPAL_INVESTIGATOR
References:
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