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NCT07846917
Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use
Conditions: Cerebral Palsy, Sleep Disorders, Caregiver Burden
Sex: All
Healthy volunteers: No
Enrollment: 150
Sponsor: Atılım University
Location: Atılım University Ankara
Summary
This observational study aims to compare sleep quality, caregiver burden, stress, and self-efficacy between parents of children with spastic diplegic cerebral palsy who use night orthoses and those who do not. Approximately 150 parents will be included and divided into two groups according to their children's night orthosis use. The study will investigate whether night orthosis use is associated with differences in parental sleep quality, caregiver burden, stress, and self-efficacy.
Eligibility Criteria
Inclusion Criteria:
* Being the parent of a child aged 6-15 years diagnosed with spastic diplegic cerebral palsy.
* Being the child's primary caregiver.
* Having provided active care for at least 6 months.
* Being literate.
Providing informed consent to participate in the study.
Exclusion Criteria:
Parent-related criteria:
* Having a diagnosed severe psychiatric disorder.
* Regular use of medications affecting sleep patterns (e.g., sedatives).
* Having a severe chronic disease (e.g., advanced cardiac or renal disease).
* Having experienced a major acute stressor (e.g., bereavement or trauma) within the previous month.
* Having a primary neurological disorder directly affecting sleep.
Child-related criteria:
* Having undergone orthopedic surgery within the previous 3 months.
* Having received botulinum toxin injections within the previous 3 months.
* Having severe epilepsy or a history of uncontrolled seizures.
Source: ClinicalTrials.gov (NCT07846917). StuddyBuddy aggregates publicly available trial information.