Understanding the Pain-Sleep Relationship in Adolescents With Pediatric Rheumatic Disease Using 'Better Nights, Better Days for Youth': A Mixed-Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 43
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
Overall, our understanding of how pain and sleep are experienced and how they can be treated in teenagers with rheumatic diseases is limited. This two-phased study aims to deepen our understanding of pain and sleep in this population using 'Better Nights, Better Days for Youth' (BNBD-Youth). 'BNBD-Youth' is a self-guided web-based sleep program for teenagers with sleep problems that uses educational and behavioural strategies, such as understanding sleep processes and changing unhelpful thoughts about sleep, to help improve sleep experiences. In Phase One, participants will use daily diaries to record their sleep and pain, and then use 'BNBDYouth' for five weeks to test whether it improves these outcomes. Then, in Phase Two, these participants will take part in an interview to further describe their experiences using 'BNBD-Youth' and their pain and sleep.
详细描述
Across two phases, this research will use an explanatory sequential mixed methods design involving (1) a single-arm trial of Better Nights, Better Days for Youth (BNBD-Youth) with 30 adolescents, aged 12-18, with a chronic pediatric rheumatic disease to characterize the correlational pain-sleep relationship and to estimate the preliminary effectiveness of the web-based sleep program on sleep and pain outcomes. These quantitative findings will guide the selection of participants, and the interview questions asked in the (2) subsequent qualitative study involving individual, semi-structured interviews with 10-26 quantitative participants to further contextualize the pain-sleep relationship using the personal pain and sleep experiences reported by participants. The quantitative and qualitative datasets will be analyzed separately and then merged during the interpretation phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent,
- •Can speak, read, and write in English,
- •Are an adolescent between the ages of 12 and 18 years,
- •Have a confirmed diagnosis of a chronic pediatric rheumatic disease,
- •Report at least a one-month history of dissatisfactory sleep quantity or quality with difficulty initiating sleep, difficulty maintaining sleep, or early-morning awakenings with an inability to return to sleep experienced at least three nights a week,
- •Report a minimum of mild pain (i.e., at least 1/10 pain on a numeric rating scale) at least once in the past week, and
- •Have access to the Internet and an email account.
排除标准
- •Have a hearing, visual, or cognitive impairment that would prevent the completion of outcome measures, as indicated by the healthcare team,
- •Have a sleep disorder that requires medical or surgical intervention,
- •Are currently receiving sleep-related psychosocial care, or
- •Have used 'Better Nights, Better Days for Youth' before.
研究组 & 干预措施
Intervention Arm
干预措施: Better Nights, Better Days for Youth (Behavioral)
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: Baseline and immediately post-intervention (5 weeks post intervention-start)
The Insomnia Severity Index (ISI) is a 7-item, validated self-report questionnaire that assesses the nature, severity, and impact of sleep over the past 2 weeks, with a total score ranging from 0-28. It has an acceptable internal consistency (Cronbach's α = 0.74) and is selected as Phase One's primary outcome because it is: 1. Frequently used in sleep research with older children, 2. Brief and easy to complete, and 3. Sensitive to perceived sleep impact after treatment.
次要结局
- PROMIS Pediatric Pain Interference - Short Form 8a(Baseline and immediately post-intervention (5 weeks post intervention-start))
- Pain Symptom Tracker(Baseline and immediately post-intervention (5 weeks post intervention-start))
- Sleep Diary(Baseline and immediately post-intervention (5 weeks post intervention-start))
- Actigraphy(Baseline and immediately post-intervention (5 weeks post intervention-start))
研究者
Jennifer Stinson
Senior Scientist, Child Health Evaluative Sciences
The Hospital for Sick Children