The Effect of Progressive Relaxation Exercises Applied to Patients With Epilepsy

Epilepsy Clinical Trial

Official title:

The Effect of Progressive Relaxation Exercises Applied to Patients With Epilepsy on Depression, Sleep and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05127499
• Other study ID #: E-97132852-050.01.04-87886
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: July 2022
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• progressive relaxation exercises
progressive relaxation exercises will do

Locations

Country	Name	City	State
Turkey	Firat Üniversitesi	Elazig

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Quality of Life in Epilepsy-31	Its validity and reliability have been verified by Mollaoglu 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

External Links

•   Controlled Examination of Effects of Progressive Relaxation Training on Seizure Reduction