- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05276635
Sleep Disorder Manage in Emotional Freedom Techniques vs Sleep Hygiene Education Group Therapy
Effectiveness of Emotional Freedom Techniques vs Sleep Hygiene Education Group Therapy (SHE) in Management of Sleep Disorders Among Elderly
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Mersa Matruh, Egypt, 51511
- Faculty of Nursing, Matrouh University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients suffering insomnia sleep problem
- Age equal or more than 60 years
Exclusion Criteria:
- Those having major physical or psychiatric ailments or being on medication affecting their sleep were excluded
- These involved those history of epilepsy, seizures, or dementia, current alcohol or substance abuse/dependence (must have >90 days of sobriety), night shift workers, as well as those unable to complete the study questionnaires and psychological tests.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Control (EFT)
had a form of Emotional Freedom Techniques (EFT) adapted for use with insomnia (EFT-I)
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30 participants had a form of Emotional Freedom Techniques (EFT) adapted for use with insomnia (EFT-I).
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ACTIVE_COMPARATOR: Sleep Hygiene Education (SHE) intervention group
received a Sleep Hygiene Education (SHE) intervention
|
Patients were randomized into two equal groups of 30 participants each.
One group received a Sleep Hygiene Education (SHE) intervention
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
poor quality sleep (PSQI)
Time Frame: The tool filling can be completed in 5-10 minutes
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The tool consists of 19 items from which seven components covering different aspects of sleep are computed to produce one composite global score.
These are sleep latency asking about how long it takes to fall asleep, sleep duration, habitual sleep efficiency measuring the percentage of sleep time of total bedtime, sleep disturbances, use of sleeping medication, daytime dysfunction, in addition to overall subjective sleep quality.
Each item is weighted on a 0-3 interval scale, with a higher score indicating worse quality.
The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
For categorical analysis, the total score in dichotomized into good sleep quality (total score <=5), and poor sleep quality (total score >5) [15].
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The tool filling can be completed in 5-10 minutes
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Geriatric Depression Scale (GDS-15)
Time Frame: The tool filling can be completed in 5-10 minutes
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The Geriatric Depression Scale 15-item version.
It also helps in the assessment of the severity of these symptoms and in treatment follow-up.
we applied the modifed 15-question shorter version as proposed by Sheikh and Yesavage 1986, and its validity was put in evidence.
The tool has 15 items such as: "Are you basically satisfied with your life?", "Do you often get bored?","
Do you feel happy most of the time?", "Do you think that most people are better off than you are?".
The response to each item is either Yes or No.
These are scored 1 and zero respectively.
The scoring was reversed for positive items so that a higher score indicates more severe depression.
The scores of the items are summed-up giving a total score ranging from 0 to 15.
For categorical analysis, the total score in dichotomized into: no depression (total score <=5), and depression (total score >5).
The validated Arabic version of this tool was used in the present study.
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The tool filling can be completed in 5-10 minutes
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Satisfaction with Life (SWL) scale
Time Frame: The tool filling can be completed in 5-10 minutes
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The third tool was the Satisfaction with Life (SWL) scale. This tool was developed by Diener et al. [23], to assess a person's to overall subjective feeling of satisfaction with his/her life. The tool consists of five items such as "In most ways my life is close to my ideal", "If I could live my life over, I would change almost nothing." The responses are on a 7-point Likert type scale ranging from "strongly disagree' to "strongly agree." These are scored from one to seven. The scores of the items are summed-up giving a total score ranging from 5 to 35. For categorical analysis, the total score in dichotomized into: dissatisfied (total score 5-20), and satisfied (total score 21-35). Research demonstrated high tool validity and reliability [24, 25]. Arabic version of this tool was used in the present study. The validity of this Scale according to Cronbach's alpha was 0.87 |
The tool filling can be completed in 5-10 minutes
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Pilot study
Time Frame: two months
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A pilot study was conducted on six patients representing 10% of computed sample size to test the clarity of the data collection form and the feasibility of the research process.
Needed modifications were carried out based on the results of the pilot study, and the tool was finalized accordingly.
The patients involved in the pilot were excluded from the study to avoid contamination of the study sample.
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two months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0305317/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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