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The Effect of Progressive Relaxation Exercises Applied to Patients With Epilepsy

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
progressive relaxation exercises
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring Epilepsy, depression, progressive relaxation exercises, sleep quality of life

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 55 ≤age ≥18
  • Ability to communicate adequately
  • Not having a diagnosed psychiatric disorder,
  • Those who are determined by the physician that they do not have a physical disability in exercising
  • Volunteering to participate in the research
  • Individuals who have the ability to use technological tools
  • A score of >5 on the Pittsburgh Sleep Quality Scale
  • Having a score of >9 on the Beck Depression Scale

Exclusion Criteria:

  • Those who have communication problems
  • Those with psychiatric problems

Sites / Locations

  • Fırat Üniversitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental:

No Intervention

Arm Description

will do progressive relaxation exercises

won't do progressive relaxation exercises

Outcomes

Primary Outcome Measures

Pittsburgh Sleep Quality Index
Pitssburg Sleep Quality Index, Buysse et al. It is a scale that gives a quantitative measure of sleep quality for the purpose of defining good and bad sleep. It includes a total of 24 questions. 19 of these questions are self-evaluation questions, five of which are answered by the spouse or a roommate. When calculating the index score, questions answered by the individual's spouse or roommate are not included in the calculation.The scale total score clearly distinguishes good sleepers (Scale total score ≤5) from poor sleepers (Scale >5)
Beck Depression Scale
It is a self-assessment type scale developed by Beck et al. (1961) to measure the level of depression symptoms and change in severity in the adult age group. The Turkish validity and reliability study was performed by Hisli (1988). It consists of 21 items that measure the symptoms in the vegetative, emotional, cognitive and motivational areas of depression.Minimal depression 0-9, Mild depression 10-16, Moderate depression 17-29, Severe depression 30-63
Quality of Life in Epilepsy-31
Its validity and reliability have been verified by Mollaoğlu et al.. Only epilepsy-related issues are questioned in the scale. It consists of 7 sub-dimensions. These sub-dimensions are; seizure anxiety (5 items), emotional well-being (5 items), energy/fatigue (4 items), social function (5 items), cognitive function (6 items), effects of drugs (3 items), total quality of life (2 items) and an additional item evaluating the total health status. The scale is scored between 0-100. A high score reflects a high quality of life.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2021
Last Updated
July 18, 2022
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05127499
Brief Title
The Effect of Progressive Relaxation Exercises Applied to Patients With Epilepsy
Official Title
The Effect of Progressive Relaxation Exercises Applied to Patients With Epilepsy on Depression, Sleep and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
April 15, 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
No

5. Study Description

Brief Summary
Epilepsy; It is a disease characterized by sudden, repetitive, epileptic seizures that are not triggered by an identifiable event and occur as a result of abnormal and excessive electrical discharge in cortical neurons from ancient times to the present. It is known that epilepsy has important social and psychological effects. Seizure recurrence and fear of social exclusion are life-threatening factors for epilepsy patients. These difficulties negatively affect the quality of life of patients by causing high levels of anxiety, depression, sleep disorders and low self-esteem. Many positive effects of progressive relaxation exercises on anxiety, depression, sleep and quality of life have been observed. The aim of this study is to examine the effects of progressive relaxation exercises applied to epilepsy patients on depression, sleep and quality of life. This study, which was planned as an experimental study with a pretest-posttest control group, will be carried out by randomly dividing 60 patients diagnosed with epilepsy, who applied to the Neurology Outpatient Clinic and Clinic of Fırat University Hospital, between September 2021 and June 2022, into 2 groups as intervention and control groups. Written consent will be obtained from the patients who agreed to participate in the study at the beginning of the study, and the study will begin. Before any intervention is made in the intervention group and control group, a pre-test will be performed using the Patient Information Form, Beck Depression Scale, Pitssburg Sleep Quality Index, and Quality of Life Scale (QOLIE 31) to evaluate depression, sleep and quality of life of these patients. The intervention group will be given progressive relaxation exercises 3 times a week for 4 weeks and the control group will not make any interventions. With the posttest, both the intervention and control groups will be filled with the Patient Information FormBeck Depression Scale, Pitssburg Sleep Quality and Quality of Life Scale (QOLIE 31) and depression, sleep and quality of life will be evaluated. Finally, it will be checked whether there is a significant difference between the pretest and the posttest.
Detailed Description
epilepsy ; It is a condition characterized by sudden, repetitive, epileptic seizures that are not triggered by an identifiable event, resulting from abnormal and excessive electrical discharge in cortical neurons from ancient times to the present. In other words, epilepsy is one of the most common and chronic serious neurological diseases that require significant behavioral and psychosocial adjustments, for which a high quality of life is aimed by keeping seizures under control. In the study conducted by Rousseau et al. on 8 epileptic subjects, it was observed that the progressive relaxation exercises they applied decreased the frequency of seizures and increased the sense of well-being. It was found that it caused significant decreases in the level of depression. There is no study in the literature examining the Effect of Progressive Relaxation Exercises Applied to Epilepsy Patients on Depression, Sleep and Quality of Life. For this reason, it was aimed to examine the effects of progressive relaxation exercises applied to epilepsy patients on depression, sleep and quality of life by conducting an experimental study with a pretest-posttest control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, depression, progressive relaxation exercises, sleep quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental:
Arm Type
Experimental
Arm Description
will do progressive relaxation exercises
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
won't do progressive relaxation exercises
Intervention Type
Other
Intervention Name(s)
progressive relaxation exercises
Intervention Description
progressive relaxation exercises will do
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
Pitssburg Sleep Quality Index, Buysse et al. It is a scale that gives a quantitative measure of sleep quality for the purpose of defining good and bad sleep. It includes a total of 24 questions. 19 of these questions are self-evaluation questions, five of which are answered by the spouse or a roommate. When calculating the index score, questions answered by the individual's spouse or roommate are not included in the calculation.The scale total score clearly distinguishes good sleepers (Scale total score ≤5) from poor sleepers (Scale >5)
Time Frame
4 week
Title
Beck Depression Scale
Description
It is a self-assessment type scale developed by Beck et al. (1961) to measure the level of depression symptoms and change in severity in the adult age group. The Turkish validity and reliability study was performed by Hisli (1988). It consists of 21 items that measure the symptoms in the vegetative, emotional, cognitive and motivational areas of depression.Minimal depression 0-9, Mild depression 10-16, Moderate depression 17-29, Severe depression 30-63
Time Frame
4 week
Title
Quality of Life in Epilepsy-31
Description
Its validity and reliability have been verified by Mollaoğlu et al.. Only epilepsy-related issues are questioned in the scale. It consists of 7 sub-dimensions. These sub-dimensions are; seizure anxiety (5 items), emotional well-being (5 items), energy/fatigue (4 items), social function (5 items), cognitive function (6 items), effects of drugs (3 items), total quality of life (2 items) and an additional item evaluating the total health status. The scale is scored between 0-100. A high score reflects a high quality of life.
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 55 ≤age ≥18 Ability to communicate adequately Not having a diagnosed psychiatric disorder, Those who are determined by the physician that they do not have a physical disability in exercising Volunteering to participate in the research Individuals who have the ability to use technological tools A score of >5 on the Pittsburgh Sleep Quality Scale Having a score of >9 on the Beck Depression Scale Exclusion Criteria: Those who have communication problems Those with psychiatric problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülcan Bahcecioglu Turan, PhD
Organizational Affiliation
Firat University
Official's Role
Study Chair
Facility Information:
Facility Name
Fırat Üniversitesi
City
Elazığ
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/1628583/
Description
Controlled Examination of Effects of Progressive Relaxation Training on Seizure Reduction

Learn more about this trial

The Effect of Progressive Relaxation Exercises Applied to Patients With Epilepsy

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