Epilepsy in ChildrenNCT06300814
The Effect of Exercise and Music on Sleep, Quality of Life and Emotional State in Children With Epilepsy
A study testing Progressive relaxation exercise group and Music recital group in people with Epilepsy in Children, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 16 years
- Conditions the study is for
- Epilepsy in Children
- What is being tested?
- Progressive relaxation exercise group and Music recital group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 26 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
This randomized controlled experimental study will be conducted to evaluate the effect of progressive relaxation exercise and music recital before going to sleep on sleep, quality of life and emotional state in children with epilepsy. The study will be conducted with children aged 9-16 years and their mothers hospitalized in a tertiary care hospital. Children in the progressive relaxation exercise (n=15), music recital (n=15) and control (n=15) groups will be selected similarly in terms of age, gender, educational status, duration of diagnosis and number. The data of the study will be collected with the Quality of Life Scale in Children Parent Form (QoLQS-PPP), Pediatric Symptom Checklist-17 (PSCL-17), Child Sleep Habits Questionnaire (CSHQ) to be administered to mothers and the Quality of Life Scale in Children Child and Adolescent Form (QoLQ-C), Me and My Emotions in Children and Adolescents Scale (MEAS), and Sleep Deprivation Scale for Children and Adolescents (PSSAD) to be administered to children. Children in the PRE group will be asked to do PRE before going to sleep five days a week (4 weeks) with a PRE video for a total of 15 minutes each session. Children in the music group will be asked to listen to the selected music before going to sleep five days a week (4 weeks) for a total of 15 minutes each session. These scales will be applied to the children before the interventions (Time 1). After the interventions were performed five days a week (4 weeks) for a total of 15 minutes each session before going to sleep, the same scales will be applied again (Time 2) and the results of the study will be compared. Children in the control group will receive standard treatment. In the evaluation of the data showing normal distribution; Student t (between 2 groups) and One Way ANOVA (more than 2 groups) tests will be used to test whether there is a difference between two independent groups; Paired-samples t test will be used to test whether there is a difference between the measurements before and after the intervention. In the evaluation of non-normally distributed data; Mann-Whitney U (between 2 groups) and Kruskal-Wallis Analysis of Variance (more than 2 groups) tests will be used to test whether there is a difference between two independent groups; Wilcoxon Paired-Samples Test will be used to test whether there is a difference between pre and post intervention measurements. A value of p<0.05 was considered statistically significant in data analysis.
- Conditions
- Epilepsy in Children
- Being tested
- Progressive relaxation exercise group, Music recital group
- Keywords
- Exercise, Music, Sleep, Quality of life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive relaxation exercise groupOther
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).
Music recital groupOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Progressive relaxation exercise group | Experimental | 15 children aged 9-16 years who met the inclusion and exclusion criteria. Receives: Other: Progressive relaxation exercise group |
| Music recital group | Experimental | 15 children aged 9-16 years who met the inclusion and exclusion criteria. Receives: Other: Music recital group |
| Control group | No intervention | 15 children aged 9-16 years who met the inclusion and exclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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).
Measured: 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)
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
Measured: Average 30 days: pre-intervention measurement (Time 1), 4 weeks intervention, immediately after the intervention measurement (Time 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2024
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy in ChildrenStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Usta, TC Erciyes University
- Investigators
- Emre Usta, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300814
- Sponsor's protocol ID
- ERU-HEM-EU-01
- Status last verified
- Aug 2025
- First submitted
- 1 Mar 2024
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercise and Music Recital on Sleep, Quality of Life and Emotional State in Children With Epilepsy
- ClinicalTrials.gov ID
- NCT06300814
- Acronym / sponsor ID
- ERU-HEM-EU-01
- Conditions
- Epilepsy in Children
- Keywords
- Exercise, Music, Sleep, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized controlled experimental study will be conducted to evaluate the effect of progressive relaxation exercise and music recital before going to sleep on sleep, quality of life and emotional state in children with epilepsy. The study will be conducted with children aged 9-16 years and their mothers hospitalized in a tertiary care hospital. Children in the progressive relaxation exercise (n=15), music recital (n=15) and control (n=15) groups will be selected similarly in terms of age, gender, educational status, duration of diagnosis and number. The data of the study will be collected with the Quality of Life Scale in Children Parent Form (QoLQS-PPP), Pediatric Symptom Checklist-17 (PSCL-17), Child Sleep Habits Questionnaire (CSHQ) to be administered to mothers and the Quality of Life Scale in Children Child and Adolescent Form (QoLQ-C), Me and My Emotions in Children and Adolescents Scale (MEAS), and Sleep Deprivation Scale for Children and Adolescents (PSSAD) to be administered to children. Children in the PRE group will be asked to do PRE before going to sleep five days a week (4 weeks) with a PRE video for a total of 15 minutes each session. Children in the music group will be asked to listen to the selected music before going to sleep five days a week (4 weeks) for a total of 15 minutes each session. These scales will be applied to the children before the interventions (Time 1). After the interventions were performed five days a week (4 weeks) for a total of 15 minutes each session before going to sleep, the same scales will be applied again (Time 2) and the results of the study will be compared. Children in the control group will receive standard treatment. In the evaluation of the data showing normal distribution; Student t (between 2 groups) and One Way ANOVA (more than 2 groups) tests will be used to test whether there is a difference between two independent groups; Paired-samples t test will be used to test whether there is a difference between the measurements before and after the intervention. In the evaluation of non-normally distributed data; Mann-Whitney U (between 2 groups) and Kruskal-Wallis Analysis of Variance (more than 2 groups) tests will be used to test whether there is a difference between two independent groups; Wilcoxon Paired-Samples Test will be used to test whether there is a difference between pre and post intervention measurements. A value of p<0.05 was considered statistically significant in data analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Progressive relaxation exercise group | Experimental | Other: Progressive relaxation exercise group15 children aged 9-16 years who met the inclusion and exclusion criteria. |
| Music recital group | Experimental | Other: Music recital group15 children aged 9-16 years who met the inclusion and exclusion criteria. |
| Control group | No intervention | –15 children aged 9-16 years who met the inclusion and exclusion criteria. |
Who may qualify
- Ages
- 9 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive relaxation exercise groupA 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). | Other | Progressive relaxation exercise group |
| Music recital groupThe 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). | Other | Music recital group |
Primary outcome
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).
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emre Usta principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive relaxation exercise group and Music recital group in people with Epilepsy in Children, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.