Assessment of Sleep Quality and Mental Health After Using Meditation

NCT ID: NCT05812443

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-10

Study Completion Date

2024-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Shabad Kriya Meditation

87 participants (intervention group) will be trained to perform Shabad Kriya meditation for 30 minutes, daily, before going to sleep, for 8 weeks

Group Type EXPERIMENTAL

Shabad Kriya Meditation

Intervention Type OTHER

The Shabad Krya meditation technique, used in Kundalini Yoga, will be performed by the participants of this intervention group for 8 consecutive weeks, for 30 minutes, before going to sleep. This group will be trained by a Kundalini Yoga teacher with extensive experience in Shabad Krya meditation. The evaluation of Sleep Quality, Mental Health and Spirituality parameters will be measured through specific questionnaires, shortly after the end of the eighth week of intervention, and also one month and three months after the end of the intervention.

Relaxing reading

87 participants (control group) will perform relaxing reading for 30 minutes, daily, before going to sleep, for 8 weeks

Group Type ACTIVE_COMPARATOR

Relaxing reading

Intervention Type OTHER

Relaxing reading will be performed by the participants of this control group for 8 consecutive weeks, for 30 minutes, before going to sleep. The evaluation of Sleep Quality, Mental Health and Spirituality parameters will be measured through specific questionnaires, shortly after the end of the eighth week of intervention, and also one month and three months after the end of the intervention.

Interventions

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Shabad Kriya Meditation

The Shabad Krya meditation technique, used in Kundalini Yoga, will be performed by the participants of this intervention group for 8 consecutive weeks, for 30 minutes, before going to sleep. This group will be trained by a Kundalini Yoga teacher with extensive experience in Shabad Krya meditation. The evaluation of Sleep Quality, Mental Health and Spirituality parameters will be measured through specific questionnaires, shortly after the end of the eighth week of intervention, and also one month and three months after the end of the intervention.

Intervention Type OTHER

Relaxing reading

Relaxing reading will be performed by the participants of this control group for 8 consecutive weeks, for 30 minutes, before going to sleep. The evaluation of Sleep Quality, Mental Health and Spirituality parameters will be measured through specific questionnaires, shortly after the end of the eighth week of intervention, and also one month and three months after the end of the intervention.

Intervention Type OTHER

Other Intervention Names

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Meditation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Rubens Lene Carvalho Tavares

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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Khalsa SBS, Goldstein MR. Treatment of chronic primary sleep onset insomnia with Kundalini yoga: a randomized controlled trial with active sleep hygiene comparison. J Clin Sleep Med. 2021 Sep 1;17(9):1841-1852. doi: 10.5664/jcsm.9320.

Reference Type BACKGROUND
PMID: 33928908 (View on PubMed)

Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.

Reference Type BACKGROUND
PMID: 21532953 (View on PubMed)

Lin CY, Saffari M, Koenig HG, Pakpour AH. Effects of religiosity and religious coping on medication adherence and quality of life among people with epilepsy. Epilepsy Behav. 2018 Jan;78:45-51. doi: 10.1016/j.yebeh.2017.10.008. Epub 2017 Nov 22.

Reference Type BACKGROUND
PMID: 29175219 (View on PubMed)

Related Links

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https://doi.org/10.1590/S0080-62342012000700015

Cultural adaptation and validation of the Underwood's Daily Spiritual Experience Scale - Brazilian version

Other Identifiers

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CAAE: 60582522.5.0000.5149

Identifier Type: -

Identifier Source: org_study_id

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