The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in İndividuals With Epilepsy

February 14, 2023 updated by: Neşe İŞCAN AYYILDIZ, Ataturk University

The Effect of Progressive Relaxation Exercises on Fatigue and Sleep Quality in Individuals With Epilepsy

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Giresun, Turkey, 28100
        • Giresun Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2021

Primary Completion (Actual)

December 22, 2022

Study Completion (Actual)

December 22, 2022

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

February 20, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • AtaturkUnıversıty Nusing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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