Feasibility, Acceptability, and Effectiveness of a Sleep Hygiene and Relaxation Intervention to Improve Sleep and Fatigue for Children Receiving Maintenance Chemotherapy for Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility and acceptability of intervention (The Evaluation of Sleep Tips form)
研究概览
简要总结
This pilot randomized controlled trial examined the feasibility, acceptability and effectiveness of an intervention to improve sleep quality and decrease fatigue levels in children with a diagnosis of ALL, during maintenance treatment. Families were randomized to usual care or the intervention. The intervention included a sleep hygiene and relaxation education session with a nurse practitioner, literature for home, two story books, and a follow-up phone call. Self-reported measures were used in addition to actigraphy to measure children's quality and quantity of sleep.
详细描述
Sleep is an essential restorative function that promotes both physical and cognitive health. Previous studies have demonstrated that children on Acute Lymphoblastic Leukemia (ALL) maintenance therapy have problematic sleep patterns and experience fatigue. This pilot randomized controlled trial examined the feasibility, acceptability and effectiveness of an intervention to improve sleep quality and decrease fatigue levels in children aged 4-10, with a diagnosis of ALL, during maintenance treatment. Families were randomized to usual care or the intervention. The intervention included a sleep hygiene and relaxation education session with a nurse practitioner, literature for home, two story books, and a follow-up phone call. Self-reported measures were used in addition to actigraphy to measure children's quality and quantity of sleep. Sleep tips were evaluated by intervention group families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Child aged 4-10 with a diagnosis of precursor acute B lymphoblastic leukemia (B ALL) in maintenance phase of therapy beyond 3rd course (protocol AALL0331)
- •Child and parent able to understand and read English
- •Child is within one year of age-appropriate grade in school
排除标准
- •Child who is receiving palliative care
- •Child with diagnosis of depression
- •Child who has been prescribed medications for insomnia
- •Child who has a physician-diagnosed sleep disorder (e.g. narcolepsy, restless legs syndrome)
- •Child who has received radiation therapy
- •Child has potential sleep disordered breathing (measured by Children's Sleep Habits Questionnaire)
研究组 & 干预措施
Usual care
Sleep Hygiene and Relaxation Education
干预措施: Sleep Hygiene and Relaxation Education (Behavioral)
结局指标
主要结局
Feasibility and acceptability of intervention (The Evaluation of Sleep Tips form)
时间窗: Weeks 1-4, post-intervention
The Evaluation of Sleep Tips form will use open-ended questions to ask parents about factors that promoted or prevented implementing the sleep hygiene and relaxation interventions, and which components of the intervention they implemented and in what frequency.
次要结局
- Nocturnal sleep (minutes)(Five consecutive nights on two occasions)
研究者
Sue Zupanec
Nurse Practitioner
The Hospital for Sick Children