Clinical Trials in Turkey / NCT07846917
Starting soon
Observational
Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use
NCT07846917 · tracked via the Priya Life Science Turkey tracker
Condition(s) studied
Cerebral PalsySleep DisordersCaregiver Burden
Study 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
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.
Primary outcome measure(s)
- Pittsburgh Sleep Quality Index (PSQI) — At baseline (single assessment)
Parental sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire evaluating sleep quality over the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A score greater than 5 indicates poor sleep quality. - Zarit Burden Interview — At baseline (single assessment)
Caregiver burden will be assessed using the Zarit Burden Interview (ZBI), a 22-item self-report questionnaire evaluating the physical, emotional, social, and economic burden of caregiving. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 88. Higher scores indicate greater caregiver burden. - Parenting Stress Index-Short Form (PSI-SF) — At baseline (single assessment).
Parenting stress will be assessed using the Parenting Stress Index-Short Form (PSI-SF), a 36-item questionnaire comprising three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Total scores range from 36 to 180, with higher scores indicating greater parenting stress. - Parental Self-Efficacy Scale — At baseline (single assessment)
Parental self-efficacy will be assessed using the 17-item Parental Self-Efficacy Scale. The Turkish version will be used to evaluate parents' perceived confidence in their parenting abilities. Each item is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree), yielding a total score ranging from 17 to 119. Higher scores indicate greater parental self-efficacy and therefore a better outcome.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Atılım University | Ankara | Turkey (Türkiye) |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07846917 on ClinicalTrials.gov ↗ ← All trials in Turkey