Back to resultsThe Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in İndividuals With Epilepsy
Primary Purpose
Epilepsy, Sleep, Fatigue
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PROGRESSIVE RELAXATION EXERCISE
Sponsored by
About this trial
This is an interventional supportive care trial for Epilepsy
Eligibility Criteria
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.
Sites / Locations
- Giresun Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental group
control gruop
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
fatigue severity scale
finished
Secondary Outcome Measures
pittsburg sleep quality scale
finished
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05261568
Brief Title
The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in İndividuals With Epilepsy
Official Title
The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in Individuals With Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim: It was conducted to determine the effect of web-based animation supported progressive relaxation exercise on fatigue and sleep quality in individuals with epilepsy. Material and Methods: As a randomized controlled study with a pretest- posttest model, it was conducted with individuals with epilepsy who applied to Giresun University Faculty of Medicine Neurology Outpatient Clinic between February and December 2022.The sample of the study was determined as 60 epilepsy patients, 30 of which were in the control-30 experimental group, using power analysis. The data were collected by face-to-face interview technique using Personal Information Form, Pittsburg Sleep Quality Index, Fatigue Severity Scale.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Sleep, Fatigue
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
control gruop
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PROGRESSIVE RELAXATION EXERCISE
Intervention Description
Progressive relaxation exercise will be done for 6 weeks by watching the animation video in the mobile application program.
Primary Outcome Measure Information:
Title
fatigue severity scale
Description
finished
Time Frame
An average of 1 year
Secondary Outcome Measure Information:
Title
pittsburg sleep quality scale
Description
finished
Time Frame
An average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuray DAYAPOĞLU
Organizational Affiliation
Ataturk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Giresun Training and Research Hospital
City
Giresun
ZIP/Postal Code
28100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in İndividuals With Epilepsy
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