Sleep Quality and Caregiver Burden in Children With Cerebral Palsy

NCT ID: NCT07168577

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-08
• Study Completion Date: 2026-03-08

Brief Summary

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.

Detailed Description

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.

Conditions

Cerebral Palsy; Sleep Disorders in Children; Caregiver Burden; Sleep Quality; Anxiety and Depression (Caregivers)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Selim Sezikli

OTHER_GOV

Sponsor Role: lead

Responsible Party

Selim Sezikli

Medical Doctor, Specialist in Physical Medicine and Rehabilitation

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Selim Sezikli, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Locations

Istanbul Physical Medicine and Rehabilitation Training and research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Selim Sezikli, MD

Role: CONTACT

selimsezikli@hotmail.com

+90 506 510 18 33

Cansın Medin Ceylan, Assoc. Prof.

Role: CONTACT

cansinmedin@gmail.com

+90 531 575 95 39

Facility Contacts

Selim Sezikli, MD

Role: primary

selimsezikli@hotmail.com

+902124965000

Cansın Medin Ceylan, Assoc. Prof.

Role: backup

cansinmedin@hotmail.com

+90 531 575 95 39

Other Identifiers

CP-2025-01

Identifier Type: -

Identifier Source: org_study_id