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

NCT07846917 | Not Yet Recruiting

• 1 other identifier: E-59394181-100-137245
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy; Sleep Disorders; Caregiver Burden

Keywords

Spastic Diplegic Cerebral Palsy; Night Orthosis; Sleep Quality; Caregiver Burden; Parental Stress; Parental Self-Efficacy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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

  At baseline (single assessment)

Study Arms (2)

Parents of Children Using Night Orthoses

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 Not Using Night Orthoses

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atılım University: lead

Study Sites (1)

Atılım University

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• Lang CP, Boucaut A, Guppy M, Johnston LM. Children with cerebral palsy: A cross-sectional study of their sleep and their caregiver's sleep quality, psychological health and well-being. Child Care Health Dev. 2021 Nov;47(6):859-868. doi: 10.1111/cch.12897. Epub 2021 Jul 26.

  PMID: 34265112 BACKGROUND

• Mol EM, Monbaliu E, Ven M, Vergote M, Prinzie P. The use of night orthoses in cerebral palsy treatment: sleep disturbance in children and parental burden or not? Res Dev Disabil. 2012 Mar-Apr;33(2):341-9. doi: 10.1016/j.ridd.2011.10.026. Epub 2011 Nov 25.

  PMID: 22119679 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Sleep Wake Disorders; Caregiver Burden; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Süleyman Korkusuz, PhD

  Atılım University

  PRINCIPAL INVESTIGATOR

• Büşra Seçkinoğulları Korkusuz

  Ankara University

  STUDY CHAIR

Central Study Contacts

Süleyman Korkusuz, PhD

CONTACT

+905388675480; suleyman.korkusuz@atilim.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)