Sleep, Pain and Health-related Quality of Life in Chronic Pain Patients. Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 554
- 试验地点
- 2
- 主要终点
- Health-related Quality of Life (HrQoL) questionnaire (15D)
研究概览
简要总结
The interventional study will have two main aims. First, to compare two interventions aiming to improve sleep in chronic pain patients. And secondly, to study the associations of sleep, mood, chronic pain and quality of life. Half of participants will go through iCBT intervention for insomnia and the other half will receive sleep hygiene education. Additionally, the study will gather information which patients will benefit/will not benefit the tertiary pain clinic treatment when the outcome variable is the Health-related Quality of Life (HrQoL).
详细描述
Sleep disturbances associates closely with chronic pain. It now seems that sleep problems usually precede and maintain persistent pain. Anxiety and worry frequently precede and associate with disturbed sleep and chronic pain. Depression is usually a consequence of chronic pain. Pain and depression disturb sleep further. These elements form a vicious circle where poor sleep is a critical driver.
Previous studies have shown that sleep disturbances are a major contributor to the poor health-related quality of life (HRQoL) of patients with chronic pain.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fluency in Finnish
排除标准
- •severe psychiatric conditions (e.g. scizopherenia)
结局指标
主要结局
Health-related Quality of Life (HrQoL) questionnaire (15D)
时间窗: Change from Baseline HrQoL at 12 months
15-item questionnaire of HrQoL, ranging from 15 to 75 smaller value indicates better HrQoL
次要结局
- Pain related catastrophizing (PCS)(Change from Baseline pain related catatsrophizing at 12 months)
- Stress and worrying tendency(Change from Baseline stress and worrying tendency at 12 months)
- Insomnia Severity Index (ISI)(Change from Baseline symptoms of insomnia at 12 months)
- Mood -BDI-II and STAI-Y(Change from Baseline mood at 12 months)
- Brief Pain Inventory (BPI)(Change from Baseline pain intensity and interference at 12 months)
研究者
Reetta Sipilä
PhD
Helsinki University Central Hospital