The Impact of Sleep Disordered Breathing on Parental Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- A change in the PAR-ENT-QoL questionnaire score
研究概览
简要总结
In this prospective case-control study the investigators will enrolled parents of 45 children younger than five years of age who were planned to undergo adenotonsillectomy due to an obstructive airway indication in an academic medical center. A group of parents to healthy children will comprise the control group.
详细描述
Parents of children with any chronic illness may experience increased anxiety and reduced health-related quality of life (QoL).
In this study, the investigators will analyze QoL parameters among parents of obstructive sleep disordered breathing (OSDB) children before and after surgical treatment.
In this prospective case-control study the investigators will enrolled parents of 45 children younger than five years of age who are planned to undergo adenotonsillectomy due to an obstructive airway indication in an academic medical center. A group of parents to healthy children will comprisedthe control group.
The investigators will translate and validate the PAR-ENT-QoL questionnaire through forward-backward translation method.
Main outcome measure: The questionnaire was tested for reliability, consistency, reproducibility, responsiveness, and for its clinical use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents of children younger than five years old who suffered from OSDB and underwent tonsillectomy or tonsillotomy with or without adenoidectomy
排除标准
- •We excluded parents of children who required immediate surgery or had any other chronic diseases (such as ADHD, asthma, allergic rhinitis or severe medical or mental impairments).
结局指标
主要结局
A change in the PAR-ENT-QoL questionnaire score
时间窗: Change from PAR-ENT-QoL questionnaire score, 1-3 weeks before surgery to 3-9 weeks after surgery
translated and validated the PAR-ENT-QoL questionnaire through forward-backward translation method.
次要结局
未报告次要终点
研究者
Ronen Ohad
Director Head and Neck Surgery Unit
Western Galilee Hospital-Nahariya