The Effect of Exercise and Music on Sleep, Quality of Life and Emotional State in Children With Epilepsy

NCT06300814 | Completed

• 1 other identifier: ERU-HEM-EU-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy in Children

Keywords

Exercise; Music; Sleep; Quality of life

Outcome Measures

Primary Outcomes (1)

• The Children's Sleep Habits Questionnaire (CSHQ)

  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 Outcomes (2)

• The Pediatric Quality of Life Inventory (PedsQL)

  Average 30 days: pre-intervention measurement (Time 1), 4 weeks intervention, immediately after the intervention measurement (Time 2)

• The Me and My School Questionnaire (M&MS)

  Average 30 days: pre-intervention measurement (Time 1), 4 weeks intervention, immediately after the intervention measurement (Time 2)

Study Arms (3)

Progressive relaxation exercise group

EXPERIMENTAL

15 children aged 9-16 years who met the inclusion and exclusion criteria.

Other: Progressive relaxation exercise group

Music recital group

EXPERIMENTAL

15 children aged 9-16 years who met the inclusion and exclusion criteria.

Other: Music recital group

Control group

NO INTERVENTION

15 children aged 9-16 years who met the inclusion and exclusion criteria.

Interventions

Progressive relaxation exercise group OTHER

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).

Progressive relaxation exercise group

Music recital group OTHER

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).

Music recital group

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Emre Usta

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 8, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2024
• Study Completion: March 26, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)