An observational study in Cerebral Palsy, Sleep Disorders and Caregiver Burden, sponsored by Atılım University. Not yet recruiting at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Atılım University · Observational
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.
Children with spastic diplegic cerebral palsy may experience sleep disturbances that can affect their parents' sleep quality and caregiving responsibilities. Night orthoses are commonly used in the management of cerebral palsy; however, their relationship with parental sleep quality and psychosocial outcomes remains unclear.
This observational, comparative study will include approximately 150 parents of children with spastic diplegic cerebral palsy. Participants will be divided into two groups: parents of children who use night orthoses and parents of children who do not use night orthoses.
Parental sleep quality, caregiver burden, stress, and self-efficacy will be assessed using standardized questionnaires. The outcomes will be compared between the two groups to examine potential associations with night orthosis use.
The findings may contribute to a better understanding of the relationship between night orthosis use and parental well-being and may help inform family-centered rehabilitation approaches.
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.
Providing informed consent to participate in the study.
Exclusion Criteria:
Parent-related criteria:
Child-related criteria:
Parents of children with spastic diplegic cerebral palsy who regularly use night orthoses. Parental sleep quality, caregiver burden, perceived stress, and self-efficacy will be assessed.
Parents of children with spastic diplegic cerebral palsy who do not use night orthoses. Parental sleep quality, caregiver burden, perceived stress, and self-efficacy will be assessed.
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.
Time frame: At baseline (single assessment)
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.
Time frame: At baseline (single assessment)
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.
Time frame: At baseline (single assessment).
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
Time frame: At baseline (single assessment)
Plan to share: No
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Atılım University