Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05812443
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-10
First Post:
2023-03-17
Brief Title:
Assessment of Sleep Quality and Mental Health After Using Meditation
Sponsor:
Federal University of Minas Gerais
Organization:
Federal University of Minas Gerais
Study Overview
Official Title:
Assessment of Sleep Quality and Mental Health After Using Meditation a Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None