- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05261568
The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in İndividuals With Epilepsy
The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in Individuals With Epilepsy
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Giresun, Turkey, 28100
- Giresun Training and Research Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- be over the age of 18
- Having been diagnosed with epilepsy for at least 6 months
- Individuals with an average score of 4.1 or higher on the fatigue severity scale
- Individuals with a Pittsburg Sleep Quality Index total score above 5
- Being able to use mobile phone (IOS-Android)
- Being able to speak Turkish
- Up to 6 months before the study, techniques such as meditation, hypnosis, yoga not benefited,
- Having a neurological, systemic and psychiatric disease other than epilepsy not to be.
Exclusion Criteria:
- Not using a mobile phone,
- Up to 6 months before the study, techniques such as meditation, hypnosis, yoga to have benefited,
- Having a neurological, systemic and psychiatric disease other than epilepsy be.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
The first application is carried out by a researcher close to the polyclinic with care and demonstration. The application will be suggested by hanging it from side to side in sitting position. They will be informed about the same application conditions in their own practice at home. The program, which will last for 6 weeks, will continue from the home environment after a video surveillance observed by the beneficiary. Periods of entry and exit times thanks to the mobile program. It will be done over the phone by the people who will come for 6 weeks. history book, lack of tools, etc. a website will be searched. Adhering to application products through study. A total of 42 sessions for 6 weeks, 7 days a week. About 30min. It is used to benefit from training to benefit from sustained progression. Apart from that, he can enjoy wearing it by dressing casually and casually. |
Progressive relaxation exercise will be done for 6 weeks by watching the animation video in the mobile application program.
|
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No Intervention: control gruop
The control group did not receive any intervention other than their own treatment during the study. will not be applied. Progressive relaxation exercise application to the individuals included in the control group personal information form, Pittsburgh sleep quality index, fatigue severity scale will be applied as test-post-test. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fatigue severity scale
Time Frame: An average of 1 year
|
finished
|
An average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pittsburg sleep quality scale
Time Frame: An average of 1 year
|
finished
|
An average of 1 year
|
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
- AtaturkUnıversıty Nusing
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.
Clinical Trials on Epilepsy
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UCB PharmaCompletedEpilepsy, Tonic-clonic
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