Quality of Life Clinical Trial
Official title:
Assessment of Sleep Quality and Mental Health After Using Meditation: a Randomized Controlled Trial
Verified date | May 2023 |
Source | Federal University of Minas Gerais |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 174 |
Est. completion date | March 2024 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Minas Gerais | Belo Horizonte | Minas Gerais |
Lead Sponsor | Collaborator |
---|---|
Federal University of Minas Gerais | Harvard Medical School (HMS and HSDM) |
Brazil,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Sleep Efficiency Change | Sleep efficiency is calculated as the number of hours asleep divided by the number of hours in bed with the intention to sleep. Sleep efficiency will be calculated from online sleep diaries that will be completed by participants in this study at baseline (T1), immediately after after 8 weeks of intervention (T2), 1 month (T3) and 3 months (T4) after intervention. Sleep efficiency is calculated using sleep parameters extracted from these diaries as sleep onset latency (SOL), total sleep time (TST), total wake time (TWT), Wake After Sleep Onset (WASO). | Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4) | |
Secondary | Self-Reported Quality of Life Change | Self-reported quality of life will be measured at baseline (T1), immediately after after 8 weeks of intervention (T2), 1 month (T3) and 3 months (T4) after intervention using the Quality of Life - Brief Mode of World Health Organization (WHOQOL-Bref), a short 26-question version validated questionnaire. The WHOQOL-Bref provides a quality of life measure with four domain scores. Each item is weighted on a 0-5 interval scale. The WHOQOL-BREF score is then calculated according to the method described by the WHO, by totaling the 4 domain scores (physical health; psychological health; social relationships; and environment). The calculation method of the scores in a certain domain is: (summation of the scores in each domain) x 4 / (number of items in a category). The adjusted scores of each domain are as low as 4 points and as high as 20 points. The overall score ranges from 16 to 80, where higher scores denote a higher life quality. | Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4) | |
Secondary | Depression Anxiety Stress Scale (DASS)-21 Change | Change in Depression, Anxiety, and Stress will be measured using the Depression, Anxiety and Stress Scales short form (DASS-21). Each of the 21 items has a minimum value of 0 and a maximum value of 3, and summed to yield independent depression, anxiety, and stress scores. Higher scores indicate severe psychological distress. | Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4) | |
Secondary | Duke University Religion Index (DUREL) Change | The Duke University Religion Index (DUREL) is a five-item measure of religious involvement. The instrument assesses the three major dimensions of religiosity that were identified during a consensus meeting sponsored by the National Institute on Aging (organizational religious activity, non-organizational religious activity, and intrinsic religiosity). The DUREL measures each of these dimensions by a separate "subscale". The DUREL has been used in many published studies conducted throughout the world and is available in many validated different languages questionnaires. | Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4) | |
Secondary | Insomnia Severity Index (ISI) Change | Insomnia Severity Index (ISI) will be used to assess insomnia-related complaints. It is a short and easy self-applied scale with 7 items scored from 0 to 4, with a total score varying from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia involvement. Patients are considered to be with no symptoms of insomnia if the ISI score is lower then 8. 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. | Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4) | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) Change | The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire that assesses sleep quality and disturbances over a 1-month period. Sleep quality will be measured by the Pittsburgh Sleep Quality Index. The PSQI has seven components, with a global PSQI score > 5 is indicative of poor sleep quality. | Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4) | |
Secondary | The Perceived Stress Scale (PSS) Change | The Perceived Stress Scale (PSS) is a five-point Likert-type scale and consists of 14 items. Participants rate each item on a scale ranging from "Never (0)" to "Very often (4)". Seven of the items with positive statements are scored in reverse. As the scores obtained from the scale increase, the perceived stress level of the person increases. PSS-14 scores range from 0 to 56, with 0-35 point range indicating normal stress level, 35-56 point range indicating that the individual is under stress. | Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4) | |
Secondary | Functional Assessment of Chronic Illness Therapy (FACIT-Sp-12) Change | The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp-12) will be used to assess spiritual well-being and comprises 12 items, each rated on a 5-point scale by the respondent. The first eight items constitute the meaning/peace factor, and the last four items constituted the faith factor. The FACIT-SP-12 questionnaire assesses a sense of meaning, peace, and comfort and strength derived from faith. The FACIT-SP-12 has a 5-point Likert-type scale format. Total scores range from 0 to 48 with higher scores indicating higher levels of spiritual well-being. | Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4) | |
Secondary | Daily spiritual experiences scale (DSES) Change | The Daily spiritual experiences scale (DSES) will be used to assess ordinary experiences of connection with the transcendent in daily life. It includes constructs such as awe, gratitude, mercy, sense of connection with the transcendent and compassionate love. It also includes measures of awareness of discernment/inspiration and a sense of deep inner peace. The DSES is a 16-item self-report measure questionnaire, and higher scores are associated with higher life satisfaction and self-reported good health. The first 15 items are arranged on a Likert-type scale, with scores ranging from 1 (many times a day) to 6 (never or almost never). The item 16 is answered on a 4-point scale (from 1 = not at all to 4 = as close as possible). The score of item 16 is inverted to maintain the same direction as the other items. The total score is obtained by adding the scores of the 16 items, ranging from 16 to 94. Lower scores reflect a higher frequency of spiritual experiences | Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4) | |
Secondary | Five Facet Mindfulness Questionnaire (FFMQ-BR) Change | The Five Facet Mindfulness Questionnaire (FFMQ-BR) will be used to assess the characteristics of mindfulness. The FFMQ-BR is subdivided into five main evaluation factors (observation, description, non-judgment, non-reactivity and conscientious acting) evaluated in the situations addressed in each item, and each item is rated by the participant using a scale ranging from 1 to 5 points, where 1 represents "never or almost never" and 5 represents "always or almost always". The total score of the questionnaire will be calculated and this score will be compared before and after all intervention to assess whether the participants' level of attention has increased. | Baseline (T1), after 8 weeks of intervention (T2), 4 weeks after the end of the intervention (T3), and 12 weeks after the end of the intervention (T4) |
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