The RELAX TO SLEEP Study: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Total nocturnal sleep at hospital
研究概览
简要总结
Sleep is a biological process essential for health. Being hospitalized can exacerbate common sleep difficulties in children. Factors that contribute to sleep disturbances during hospitalization include environmental, physiological, and psychological factors. Although sleep interventions exist for healthy children in the community, interventions aimed at hospitalized children need to be developed and piloted with rigorous evaluative methods. The primary purpose of this study is to examine the feasibility and acceptability of the RELAX TO SLEEP program on hospitalized children. Although this study is a pilot study, comparisons will be made to examine sleep outcomes between the intervention group and the control group including: total nocturnal (19h30-07h29), number of nighttime awakenings, longest stretch of nocturnal sleep, and total daytime (07h30-19h29) sleep. Other comparisons include anxiety levels and the development of post-hospital maladaptive behaviours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 4 and
- •Children expected to stay for 3 nights.
- •Children must have a parent present that plans to stay overnight with the child and must understand English (parent must read English).
- •Child must be in a single private room.
排除标准
- •Children who are receiving palliative care only during their hospital admission.
- •Children diagnosed with a sleep disorder or a clinical anxiety disorder.
- •Children with limited or abnormal movements of both upper and lower extremities (e.g. paralysis, brain injury, cerebral palsy, use of drugs to induce paralysis, musculoskeletal impairments, use of restraints, under heavy sedation), thereby impairing sleep wake activity recording and the inability to use the relaxation breathing exercise.
- •Children who are too acutely ill to participate in the study.
- •Children who have major cognitive impairments that may impact their ability to understand and carry out the intervention.
- •Children who are heavily sedated or receiving benzodiazepines or chloral hydrate.
研究组 & 干预措施
Experimental group (RELAX TO SLEEP program)
干预措施: Relax To Sleep Program (Behavioral)
Control group (Usual Care)
结局指标
主要结局
Total nocturnal sleep at hospital
时间窗: total measured over 3 days and 3 nights
Nocturnal sleep in hospital as well as other sleep outcomes will be objectively measured using actigraphy.
次要结局
- Anxiety(Baseline, Day 5)
- Post-hospital maladaptive behaviours(Follow-up (5-7 days post discharge))
研究者
Robyn Stremler
Nursing Research Associate
The Hospital for Sick Children