An interventional study of online mindfulness based meditation program in Sleep Disorder, sponsored by Universidade Federal da Fronteira Sul. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Universidade Federal da Fronteira Sul · Not applicable, Interventional, and Supportive care
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
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)
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's planned enrollment of 136 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →Universidade Federal da Fronteira Sul is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: online mindfulness based meditation program
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.
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.
Change in the quality of sleep of medical students on weeks 5, 9 and 17 by the PSQI and ESE
- PSQI (Pittsburgh Quality Sleep Index) - instrument consisting of 19 self-report questions categorized into seven components, graduated in scores from zero (no difficulty) to three (severe difficulty). The components of the PSQI are: C1 subjective sleep quality, C2 sleep latency, C3 sleep duration, C4 habitual sleep efficiency, C5 sleep changes, C6 use of sleeping medications C7 daytime sleep dysfunction. The sum of the values attributed to the seven components varies from zero to twenty-one in the total questionnaire score, indicating that the higher the number, the worse the sleep quality. A total score greater than five indicates that the individual is experiencing major dysfunction in at least two components, or moderate dysfunction in at least three components. ESE (Epworth Sleepiness Scale). This is a self-administered questionnaire that assesses the probability of falling asleep in eight situations involving daily activities, some of which are known to be highly soporific. The
Time frame: week 0, week 5, week 9 and week 17
Change in the awareness of medical students on weeks 5, 9 and 17 by the MAAS
MAAS (Mindful Attention Awareness Scale). It is a 15-item unidimensional measure of mindfulness. Each item is rated on a Likert scale between 1 (almost always) and 6 (almost never) in relation to the interviewee's daily experience. Higher scores reflect higher levels of dispositional mindfulness
Time frame: week 0, week 5, week 9 and week 17
Change in the depression, anxiety and stress symptoms of medical students on weeks 5, 9 and 17 by the DASS-21
DASS-21 (Depression, Anxiety and Stress Scale) This is a questionnaire with 21 questions, which measure the intensity of behaviors and sensations experienced in the last seven days. It has the ability to simultaneously measure and distinguish depression, anxiety and stress. Each question is rated on a four-point Likert scale of frequency or severity of participants' experiences during the past week with the intention of emphasizing emotional states over these traits.
Time frame: week 0, week 5, week 9 and week 17
Change in the burnout symptoms of medical students on weeks 5, 9 and 17 by CBI-S
CBI-S (Copenhagen Burnout Inventory - Student version) is a 19-item self-report measure of burnout. To adapt the instrument to the students' context, when adapting the original format, the instrument was composed of the following dimensions: Personal Burnout (PB), Study-Related Burnout (SRB), Colleague-Related Burnout (CRB) and Student-Related Burnout. Teachers (TRB), the questions relating to the third dimension were duplicated, increasing the questionnaire to 25 questions. Five response options are used, in two domains: one for intensity and another for frequency
Time frame: week 0, week 5, week 9 and week 17
Plan to share: No — There´s no plan of IPD sharing
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidade Federal da Fronteira Sul