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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: At baseline (single assessment)
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
时间窗: At baseline (single assessment)
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)
时间窗: At baseline (single assessment).
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
时间窗: At baseline (single assessment)
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
次要结局
未报告次要终点
研究者
Süleyman Korkusuz
Assist. Prof. Dr
Atılım University