- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05127499
The Effect of Progressive Relaxation Exercises Applied to Patients With Epilepsy
The Effect of Progressive Relaxation Exercises Applied to Patients With Epilepsy on Depression, Sleep and Quality of Life
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.
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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Elazığ, Turkey
- Fırat Üniversitesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Experimental:
will do progressive relaxation exercises
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progressive relaxation exercises will do
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No Intervention: No Intervention
won't do progressive relaxation exercises
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pittsburgh Sleep Quality Index
Time Frame: 4 week
|
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)
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4 week
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Beck Depression Scale
Time Frame: 4 week
|
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
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4 week
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Quality of Life in Epilepsy-31
Time Frame: 4 week
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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.
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4 week
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gülcan Bahçecioğlu Turan, PhD, Firat University
Publications and helpful links
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
- E-97132852-050.01.04-87886
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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