Sleep Quality and Caregiver Burden in Children With Cerebral Palsy

NCT07168577 | Recruiting

• 1 other identifier: CP-2025-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Zarit Burden Interview (ZBI); Children's Sleep Habits Questionnaire (CSHQ); Cerebral palsy; Sleep quality; Pittsburgh Sleep Quality Index (PSQI); Sleep disorders; Caregiver burden; Caregiver sleep quality

Outcome Measures

Primary Outcomes (3)

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

  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.

  Day 1 (single assessment at baseline)

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

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

  Day 1 (single assessment at baseline)

• Caregiver Burden Assessed by Zarit Burden Interview (ZBI)

  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.

  Day 1 (single assessment at baseline)

Secondary Outcomes (5)

• Child Functional Level Assessed by Gross Motor Function Classification System (GMFCS)

  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)

• Caregiver Psychological Status Assessed by Hospital Anxiety and Depression Scale (HADS)

  Day 1 (single assessment at baseline)

Study Arms (1)

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.

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of children aged 2-18 years diagnosed with cerebral palsy and their primary caregivers (parents or legal guardians aged ≥18 years). Participants will be recruited from the outpatient clinics of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Selim Sezikli: lead

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Caregiver Burden; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Depression; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Selim Sezikli, MD

  Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selim Sezikli, MD

CONTACT

+90 506 510 18 33; selimsezikli@hotmail.com

Cansın Medin Ceylan, Assoc. Prof.

CONTACT

+90 531 575 95 39; cansinmedin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor, Specialist in Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 11, 2025
• Study Start: September 8, 2025
• Primary Completion: March 8, 2026
• Study Completion: March 8, 2026
• Last Updated: February 24, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data and supporting documents (study protocol, SAP, ICF) will be available beginning 6 months after study completion (September 2026) and will remain available for 2 years (until March 2028).
• Access Criteria: Qualified researchers who have obtained approval from an independent ethics committee and signed a data use agreement will be able to access the de-identified individual participant data (IPD) and supporting information (study protocol, statistical analysis plan, informed consent form). Data will include demographic characteristics, child sleep quality (CSHQ), functional classification (GMFCS, MACS, CFCS), spasticity (MAS), caregiver sleep quality (PSQI), caregiver burden (ZBI), and psychological status (HADS). All data will be provided in anonymized form to protect confidentiality. Access requests should be submitted to the principal investigator, and approved researchers will receive data electronically.

Locations

TU (1)