About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Approximately 150 parents of children aged 6-15 years with spastic diplegic cerebral palsy will be included. Parents will be classified into two groups according to their children's existing night orthosis use. Parental sleep quality, caregiver burden, parenting stress, and self-efficacy will be compared between groups.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Pittsburgh Sleep Quality Index (PSQI)
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
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)
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
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.
Sponsors and contacts
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