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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Comparison of Sleep Quality, Caregiver Burden, Stress, and Self-Efficacy Between Parents of Children With Spastic Diplegic Cerebral Palsy Who Use and Do Not Use Night Orthoses

Conditions

Cerebral Palsy, Sleep Disorders, Caregiver Burden

Keywords

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

Medical subject headings

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: 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.

   Measured: 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.

   Measured: 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.

   Measured: At baseline (single assessment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted29 Sep 2026
2. Study start1 Nov 2026 (estimated)
3. Primary completion20 Dec 2026 (estimated)
4. Study completion1 Jan 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (2)Papers the sponsor has linked to this study.
• Other trials for Cerebral PalsyStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.