The Effect of Progressive Relaxation Exercise and Music Recital on Sleep, Quality of Life and Emotional State in Children With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- The Children's Sleep Habits Questionnaire (CSHQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 9 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Progressive relaxation exercise group
15 children aged 9-16 years who met the inclusion and exclusion criteria.
干预措施: Progressive relaxation exercise group (Other)
Control group
15 children aged 9-16 years who met the inclusion and exclusion criteria.
Music recital group
15 children aged 9-16 years who met the inclusion and exclusion criteria.
干预措施: Music recital group (Other)
结局指标
主要结局
The Children's Sleep Habits Questionnaire (CSHQ)
时间窗: 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).
次要结局
- 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))
- 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))
研究者
Emre Usta
Research Assistant
TC Erciyes University