Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300814
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-01
Brief Title:
The Effect of Exercise and Music on Sleep Quality of Life and Emotional State in Children With Epilepsy
Sponsor:
TC Erciyes University
Organization:
TC Erciyes University
Study Overview
Official Title:
The Effect of Progressive Relaxation Exercise and Music Recital on Sleep Quality of Life and Emotional State in Children With Epilepsy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 p005 was considered statistically significant in data analysis
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 p005 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 n15 music recital n15 and control n15 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 p005 was considered statistically significant in data analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None