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临床试验/NCT07168577
NCT07168577已完成不适用

Evaluation of Sleep Quality and Caregiver Burden in Children With Cerebral Palsy

Selim Sezikli2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
2
主要终点
Child Sleep Quality Assessed by Children's Sleep Habits Questionnaire (CSHQ)

研究概览

简要总结

Cerebral palsy (CP) is a lifelong condition that affects movement and posture in children, often requiring continuous care from family members. Children with CP frequently experience sleep problems due to spasticity, pain, seizures, or behavioral difficulties. Poor sleep can negatively affect the child's health and development, as well as increase the physical and emotional burden on their caregivers.

This study aims to evaluate the sleep quality of children with CP and their primary caregivers, and to examine the relationship between caregiver burden and these sleep-related factors. The study will include children aged 2 to 18 years with a diagnosis of CP and their primary caregivers (parents or legal guardians).

Children's sleep patterns will be assessed using the Children's Sleep Habits Questionnaire (CSHQ). Their functional levels will be classified using the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), and Communication Function Classification System (CFCS). Caregivers' sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI), caregiver burden with the Zarit Burden Interview (ZBI), and psychological status with the Hospital Anxiety and Depression Scale (HADS).

By identifying how sleep problems are linked with caregiver burden and psychological health, this study may provide valuable insights for developing supportive intervention programs for both children with CP and their families.

详细描述

Cerebral palsy (CP) is the most common cause of motor disability in childhood and often requires long-term daily care provided by family members. Sleep disorders are highly prevalent in children with CP compared with typically developing peers and are frequently associated with spasticity, seizures, pain, and behavioral issues. Poor sleep may further compromise the child's functional capacity and quality of life. At the same time, caregivers of children with CP often face increased physical and psychological demands, including high levels of stress, anxiety, and depression, which may be exacerbated by poor sleep quality and increased caregiving burden.

Although prior studies have investigated these factors separately, there is limited research examining the combined relationship between child sleep quality, functional status, caregiver sleep quality, caregiver burden, and psychological health. A comprehensive evaluation of these interrelated aspects may help in identifying high-risk groups and developing supportive interventions for both children and caregivers.

This single-center, observational, cross-sectional study will be conducted in the outpatient Physical Medicine and Rehabilitation clinics of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. The study will recruit at least 100 child-caregiver pairs. Children aged 2-18 years with a confirmed diagnosis of CP and their primary caregivers (aged ≥18 years) will be included. Sampling will be based on convenience and voluntary participation.

Data collection will include standardized questionnaires and clinical classifications. For children, sleep quality will be assessed using the Children's Sleep Habits Questionnaire (CSHQ), while functional levels will be determined by the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), and Communication Function Classification System (CFCS). Spasticity will be evaluated with the Modified Ashworth Scale. For caregivers, sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), caregiver burden with the Zarit Burden Interview (ZBI), and psychological status with the Hospital Anxiety and Depression Scale (HADS).

All assessments will be performed by trained researchers through face-to-face interviews following standardized protocols. Data will be analyzed using descriptive statistics, correlation tests, and multivariable regression analyses to explore the associations between child sleep quality, caregiver sleep quality, caregiver burden, and psychological outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Children aged 2-18 years with a confirmed diagnosis of cerebral palsy
  • •Primary caregiver (≥18 years, parent or legal guardian) responsible for the child's daily care
  • •Ability to read and write in Turkish
  • •Sufficient cognitive capacity to complete questionnaires and participate in interviews
  • •Voluntary agreement of both the child's caregiver and participant to join the study

排除标准

  • •Presence of severe comorbid neurological or metabolic disease in the child
  • •Caregiver with a history of severe psychiatric disorder or cognitive impairment
  • •Communication problems that prevent completion of questionnaires
  • •Hospitalization within the last 3 months due to acute medical condition
  • •Withdrawal of consent or incomplete questionnaires during the study

研究组 & 干预措施

Children With Cerebral Palsy and Primary Caregivers

This cohort includes children aged 2-18 years with a confirmed diagnosis of cerebral palsy and their primary caregivers (parents or legal guardians aged ≥18 years). All participants will undergo standardized clinical and questionnaire-based assessments. For children, sleep quality will be evaluated with the Children's Sleep Habits Questionnaire (CSHQ), and functional status will be classified using GMFCS, MACS, and CFCS, while spasticity will be assessed with the Modified Ashworth Scale. For caregivers, sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI), caregiver burden with the Zarit Burden Interview (ZBI), and psychological status with the Hospital Anxiety and Depression Scale (HADS). No experimental intervention will be applied; the study is observational and cross-sectional.

结局指标

主要结局

Child Sleep Quality Assessed by Children's Sleep Habits Questionnaire (CSHQ)

时间窗: Day 1 (single assessment at baseline)

Sleep quality of children with cerebral palsy will be assessed using the parent-reported Children's Sleep Habits Questionnaire (CSHQ), a validated scale measuring common sleep behaviors and problems in children.

Caregiver Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)

时间窗: Day 1 (single assessment at baseline)

Sleep quality of caregivers will be measured using the Pittsburgh Sleep Quality Index (PSQI), which evaluates sleep patterns and disturbances over the previous month.

Caregiver Burden Assessed by Zarit Burden Interview (ZBI)

时间窗: Day 1 (single assessment at baseline)

Caregiver burden will be assessed using the Zarit Burden Interview (ZBI), a validated questionnaire evaluating the impact of caregiving on emotional, physical, and social well-being.

Child Sleep Quality Assessed by Children's Sleep Habits Questionnaire (CSHQ)

时间窗: Day 1 (single assessment at baseline)

Sleep quality of children with cerebral palsy will be assessed using the parent-reported Children's Sleep Habits Questionnaire (CSHQ), a validated scale measuring common sleep behaviors and problems in children.

Caregiver Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)

时间窗: Day 1 (single assessment at baseline)

Sleep quality of caregivers will be measured using the Pittsburgh Sleep Quality Index (PSQI), which evaluates sleep patterns and disturbances over the previous month.

Caregiver Burden Assessed by Zarit Burden Interview (ZBI)

时间窗: Day 1 (single assessment at baseline)

Caregiver burden will be assessed using the Zarit Burden Interview (ZBI), a validated questionnaire evaluating the impact of caregiving on emotional, physical, and social well-being.

次要结局

  • Child Functional Level Assessed by Gross Motor Function Classification System (GMFCS)(Day 1 (single assessment at baseline))
  • Caregiver Psychological Status Assessed by Hospital Anxiety and Depression Scale (HADS)(Day 1 (single assessment at baseline))
  • Child Functional Level Assessed by Gross Motor Function Classification System (GMFCS)(Day 1 (single assessment at baseline))
  • Caregiver Psychological Status Assessed by Hospital Anxiety and Depression Scale (HADS)(Day 1 (single assessment at baseline))
  • Manual Ability Assessed by Manual Ability Classification System (MACS)(Day 1 (single assessment at baseline))
  • Communication Function Assessed by Communication Function Classification System (CFCS)(Day 1 (single assessment at baseline))
  • Spasticity Assessed by Modified Ashworth Scale (MAS)(Day 1 (single assessment at baseline))

研究者

发起方
Selim Sezikli
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Selim Sezikli

Medical Doctor, Specialist in Physical Medicine and Rehabilitation

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

研究点 (2)

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