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Assessment of Sleep Quality and Mental Health After Using Meditation

F

Federal University of Minas Gerais

Status

Active, not recruiting

Conditions

Spirituality
Stress Disorder
Quality of Life
Insomnia Disorder
Sleep Disorder
Complementary Therapy
Insomnia
Anxiety Disorders
Depressive Disorder
Insomnia Chronic

Treatments

Other: Shabad Kriya Meditation
Other: Relaxing reading

Study type

Interventional

Funder types

Other

Identifiers

NCT05812443
CAAE: 60582522.5.0000.5149

Details and patient eligibility

About

This is a randomized controlled trial that intends to verify the effectiveness of the daily practice of meditation before going to sleep for the improvement of sleep, stress, mental health and quality of life of people with sleep problems.

Full description

Participants selected for this clinical trial will be randomized into two groups: group 1 (intervention), with 87 participants undergoing 30 minutes of Shabad Kriya meditation before going to sleep, and group 2 (control), with 87 participants who will perform 30 minutes of relaxing reading before going to sleep. In addition, participants will complete the demographic data form; a sleep quality diary; and the scales: Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PBS), Five Facets of Mindfulness (FFMQ), Daily Spiritual Experiences (DSES), Functional Assessment of Chronic Illness Therapy - Wellness Scale Spiritual (FACIT- 12), Duke Religiosity Index (DUREL), Quality of Life - Brief Mode (WHOQOL-Bref) and the Depression, Anxiety and Stress Scale (DASS 21). The study is open to the general community, and those interested are screened through the "Insomnia Severity Index" and questionnaires about health conditions. For conducting and guiding the intervention and completing the research instruments, online meetings will be held with the participants. The sleep quality diary will be completed for fourteen days before the start of the intervention (Baseline). Data collection will be carried out with online Google Forms questionnaires, sent through links in digital media, such as messages or emails, or made available in printed form. The main outcome measure will be sleep efficiency calculated using data from the sleep diary. Data from participants with ISI greater than or equal to 10 will be compared before and after the intervention. Additionally, data analysis of participants with ISI above or greater than 8 will be performed. At the end of the eighth week of the intervention (Shabad Kriya meditation or Relaxing reading), as well as one month after the end of the intervention, and three months after the end of the intervention, the participants will again fill in the questionnaires described above, for statistical comparisons.

Enrollment

174 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Clinical diagnosis of insomnia (Insomnia Severity Index between 8-28)

Exclusion criteria

  • Major medical or psychiatric problems
  • Who has used sleeping pills or sleep-disrupting medications in the last 30 days prior to participating in the study
  • Who will need to use sleeping pills or sleep-disrupting medications during the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

174 participants in 2 patient groups

Shabad Kriya Meditation
Experimental group
Description:
87 participants (intervention group) will be trained to perform Shabad Kriya meditation for 30 minutes, daily, before going to sleep, for 8 weeks
Treatment:
Other: Shabad Kriya Meditation
Relaxing reading
Active Comparator group
Description:
87 participants (control group) will perform relaxing reading for 30 minutes, daily, before going to sleep, for 8 weeks
Treatment:
Other: Relaxing reading

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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