NCT05261568

Brief Summary

Aim: It was conducted to determine the effect of web-based animation supported progressive relaxation exercise on fatigue and sleep quality in individuals with epilepsy. Material and Methods: As a randomized controlled study with a pretest- posttest model, it was conducted with individuals with epilepsy who applied to Giresun University Faculty of Medicine Neurology Outpatient Clinic between February and December 2022.The sample of the study was determined as 60 epilepsy patients, 30 of which were in the control-30 experimental group, using power analysis. The data were collected by face-to-face interview technique using Personal Information Form, Pittsburg Sleep Quality Index, Fatigue Severity Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

January 14, 2022

Last Update Submit

February 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • fatigue severity scale

    finished

    An average of 1 year

Secondary Outcomes (1)

  • pittsburg sleep quality scale

    An average of 1 year

Study Arms (2)

experimental group

EXPERIMENTAL

The first application is carried out by a researcher close to the polyclinic with care and demonstration. The application will be suggested by hanging it from side to side in sitting position. They will be informed about the same application conditions in their own practice at home. The program, which will last for 6 weeks, will continue from the home environment after a video surveillance observed by the beneficiary. Periods of entry and exit times thanks to the mobile program. It will be done over the phone by the people who will come for 6 weeks. history book, lack of tools, etc. a website will be searched. Adhering to application products through study. A total of 42 sessions for 6 weeks, 7 days a week. About 30min. It is used to benefit from training to benefit from sustained progression. Apart from that, he can enjoy wearing it by dressing casually and casually.

Behavioral: PROGRESSIVE RELAXATION EXERCISE

control gruop

NO INTERVENTION

The control group did not receive any intervention other than their own treatment during the study. will not be applied. Progressive relaxation exercise application to the individuals included in the control group personal information form, Pittsburgh sleep quality index, fatigue severity scale will be applied as test-post-test.

Interventions

Progressive relaxation exercise will be done for 6 weeks by watching the animation video in the mobile application program.

experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be over the age of 18
  • Having been diagnosed with epilepsy for at least 6 months
  • Individuals with an average score of 4.1 or higher on the fatigue severity scale
  • Individuals with a Pittsburg Sleep Quality Index total score above 5
  • Being able to use mobile phone (IOS-Android)
  • Being able to speak Turkish
  • Up to 6 months before the study, techniques such as meditation, hypnosis, yoga not benefited,
  • Having a neurological, systemic and psychiatric disease other than epilepsy not to be.

You may not qualify if:

  • Not using a mobile phone,
  • Up to 6 months before the study, techniques such as meditation, hypnosis, yoga to have benefited,
  • Having a neurological, systemic and psychiatric disease other than epilepsy be.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giresun Training and Research Hospital

Giresun, 28100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

EpilepsyFatigue

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nuray DAYAPOĞLU

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2022

First Posted

March 2, 2022

Study Start

September 10, 2021

Primary Completion

December 22, 2022

Study Completion

December 22, 2022

Last Updated

February 17, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations