Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy in Parents of Children With Spastic Diplegic Cerebral Palsy: A Comparison by Night Orthosis Use

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAtılım University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 2 trial groups
Group A: Parents of Children Using Night Orthoses
Group B: Parents of Children Not Using Night Orthoses

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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).
4

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.

Time frame
At baseline (single assessment)

Secondary outcomes

Other outcomes

Sponsors and contacts

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