Sleep and caregiver burden in children with cerebral palsy
Evaluation of Sleep Quality and Caregiver Burden in Children With Cerebral Palsy
Istanbul Physical Medicine Rehabilitation Training and Research Hospital · NCT07168577
This project will see if sleep problems in children with cerebral palsy and their caregivers are linked and how caregiver burden relates to sleep quality.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Istanbul Physical Medicine Rehabilitation Training and Research Hospital (other gov) |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07168577 on ClinicalTrials.gov |
What this trial studies
This single-center, cross-sectional observational study in Istanbul will recruit at least 100 child–caregiver pairs (children aged 2–18 years with confirmed cerebral palsy and their primary caregivers) from outpatient Physical Medicine and Rehabilitation clinics. Child sleep will be measured using the Children's Sleep Habits Questionnaire (CSHQ) and functional status classified with GMFCS, MACS, and Communication Function tools, while caregiver sleep, burden, and psychological health will be measured with instruments including the Pittsburgh Sleep Quality Index (PSQI) and the Zarit Burden Interview (ZBI). Data collection is questionnaire- and record-based with no interventions, and analyses will examine associations between child sleep quality, functional level, caregiver sleep, caregiver burden, anxiety, and depression. The aim is to identify interrelated risk factors to inform targeted support and future interventions for families of children with cerebral palsy.
Who should consider this trial
Good fit: Children aged 2–18 years with a confirmed diagnosis of cerebral palsy and their primary caregivers (aged 18 or older) who can read and write Turkish and agree to participate are the ideal candidates.
Not a fit: Children with severe comorbid neurological or metabolic disease, caregivers with severe psychiatric disorders or cognitive impairment, or anyone unable to complete the required questionnaires are unlikely to benefit from the study findings.
Why it matters
Potential benefit: If successful, the results could help clinicians identify families at high risk of poor sleep and caregiver strain so they can offer targeted support and interventions.
How similar studies have performed: Prior research has documented high rates of sleep problems in children with cerebral palsy and links between poor child sleep and caregiver stress, but comprehensive combined assessments of child sleep, functional status, caregiver sleep, burden, and psychological health are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Istanbul
- Istanbul Physical Medicine and Rehabilitation Training and research Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Selim Sezikli, MD — Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
- Study coordinator: Selim Sezikli, MD
- Email: selimsezikli@hotmail.com
- Phone: +90 506 510 18 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy, Sleep Disorders in Children, Caregiver Burden, Sleep Quality, Anxiety and Depression, Zarit Burden Interview, Children's Sleep Habits Questionnaire, Cerebral palsy