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临床试验/NCT05127499
NCT05127499已完成不适用

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

Ataturk University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Pittsburgh Sleep Quality Index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Those who have communication problems
  • Those with psychiatric problems

结局指标

主要结局

Pittsburgh Sleep Quality Index

时间窗: 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)

Beck Depression Scale

时间窗: 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

Quality of Life in Epilepsy-31

时间窗: 4 week

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

gülcan bahcecioğlu

Ataturk University

Ataturk University

研究点 (1)

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