- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06300814
The Effect of Exercise and Music on Sleep, Quality of Life and Emotional State in Children With Epilepsy
The Effect of Progressive Relaxation Exercise and Music Recital on Sleep, Quality of Life and Emotional State in Children With Epilepsy
This study was planned as a randomized controlled experimental study with a pretest-posttest design to determine the effect of parental supervision and video-guided progressive relaxation exercise (PRE) and music recital on sleep, quality of life and emotional states in children with epilepsy aged 9-16 years. The main questions it aims to answer are as follows:
According to the evaluation of children with epilepsy, does the progressive relaxation exercise applied to children have an effect on sleep, quality of life and emotional states? According to the evaluation of children with epilepsy, does music recital applied to children have an effect on sleep quality of life and emotional states? The study consisted of 45 children (15 children in the progressive relaxation exercise group, 15 children in the music recital group and 15 children in the control group). Ethics committee approval, permission from the institutions and informed consent of the children were obtained for the conduct of the study. A value of p<0.05 was considered statistically significant in data analysis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emre Usta
- Phone Number: 05377171571
- Email: usta_emre_1907@hotmail.com
Study Contact Backup
- Name: Emine Erdem
- Email: emine@erciyes.edu.tr
Study Locations
-
-
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Kayseri, Turkey
- Recruiting
- Erciyes University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between the ages of 9-16,
- Does not have a chronic or genetic disease other than epilepsy,
- No mental, visual or hearing impairment,
- Having a mother who is at least a primary school graduate,
- Both he and his mother are open to communication and cooperation,
- Children who both themselves and their mothers volunteer to participate in the research and give verbal and written consent.
Exclusion Criteria:
- Not between the ages of 9-16,
- Having a chronic or genetic disease other than epilepsy,
- Mentally, visually or hearing impaired,
- Mothers who are not primary school graduates,
- Both he and his mother are not open to communication and cooperation,
- Neither they nor their mothers volunteered to participate in the research,
- Children and mothers without smart phones
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Progressive relaxation exercise group
15 children aged 9-16 years who met the inclusion and exclusion criteria.
|
A video containing the progressive relaxation exercise was sent to the phones of the mothers of children diagnosed with epilepsy in the intervention group to whom progressive relaxation exercise would be applied, and the children applied progressive relaxation exercise (15 minutes of progressive relaxation exercise before bedtime for a total of 4 weeks, 5 days a week).
|
Experimental: Music recital group
15 children aged 9-16 years who met the inclusion and exclusion criteria.
|
The link of the music recital (link) was sent to the phones of the mothers of children diagnosed with epilepsy in the intervention group, where the music concert will be applied, and the children listened to it (music concert was applied for 15 minutes before going to bed, 5 days a week for a total of 4 weeks).
|
No Intervention: Control group
15 children aged 9-16 years who met the inclusion and exclusion criteria.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Children's Sleep Habits Questionnaire (CSHQ)
Time Frame: Average 30 days: pre-intervention measurement (Time 1), 4 weeks intervention, immediately after the intervention measurement (Time 2)
|
CSHQ, which consists of 8 subscales (resistance to going to bed, difficulty sleeping, total sleep time, sleep anxiety, frequent waking up at night, sleepiness during the day, breathing-related sleep problems and parasomnia) and 33 items, is scored 1-3 points (1 = rarely….
3 = It is generally evaluated as).
|
Average 30 days: pre-intervention measurement (Time 1), 4 weeks intervention, immediately after the intervention measurement (Time 2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Pediatric Quality of Life Inventory (PedsQL)
Time Frame: Average 30 days: pre-intervention measurement (Time 1), 4 weeks intervention, immediately after the intervention measurement (Time 2)
|
Scale; It consists of 23 items in total: physical health = 8, emotional functionality = 5, social functionality = 5, school functionality = 5 items.
The same items are available in all child and parent forms created according to age groups.
When answering the scale, a score of 0-4 was determined for each question (0 = never… 4 = almost always).
|
Average 30 days: pre-intervention measurement (Time 1), 4 weeks intervention, immediately after the intervention measurement (Time 2)
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The Me and My School Questionnaire (M&MS)
Time Frame: Average 30 days: pre-intervention measurement (Time 1), 4 weeks intervention, immediately after the intervention measurement (Time 2)
|
It consists of a total of 16 items: emotional difficulties = 10, behavioral problems = 6 items.
Each item in the scale; It evaluates to never = 0, sometimes = 1, always = 2. High scores on each subscale indicate the likelihood of mental health problems
|
Average 30 days: pre-intervention measurement (Time 1), 4 weeks intervention, immediately after the intervention measurement (Time 2)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emre Usta, TC Erciyes University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERU-HEM-EU-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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