NCT05127499

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

November 3, 2021

Last Update Submit

July 18, 2022

Conditions

Keywords

Epilepsydepressionprogressive relaxation exercisessleep quality of life

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:

EXPERIMENTAL

will do progressive relaxation exercises

Other: progressive relaxation exercises

No Intervention

NO INTERVENTION

won't do progressive relaxation exercises

Interventions

progressive relaxation exercises will do

Experimental:

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

Location

Related Links

MeSH Terms

Conditions

EpilepsyDepression

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Gülcan Bahcecioglu Turan, PhD

    Firat University

    STUDY CHAIR

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

Locations