The Effect of Progressive Relaxation Exercises Applied to Patients With Epilepsy
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 3, 2021
CompletedFirst Posted
Study publicly available on registry
November 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2022
CompletedJuly 19, 2022
July 1, 2022
6 months
November 3, 2021
July 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
4 week
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
4 week
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.
4 week
Study Arms (2)
Experimental:
EXPERIMENTALwill do progressive relaxation exercises
No Intervention
NO INTERVENTIONwon't do progressive relaxation exercises
Interventions
Eligibility Criteria
You may qualify if:
- ≤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
You may not qualify if:
- Those who have communication problems
- Those with psychiatric problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fırat Üniversitesi
Elâzığ, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gülcan Bahcecioglu Turan, PhD
Firat University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ataturk University
Study Record Dates
First Submitted
November 3, 2021
First Posted
November 19, 2021
Study Start
November 1, 2021
Primary Completion
April 15, 2022
Study Completion
April 15, 2022
Last Updated
July 19, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share