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临床试验/NCT06478628
NCT06478628Enrolling By Invitation不适用

Insomnia in Patients Participating in Interdisciplinary Pain Rehabilitation

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
1,500
试验地点
1
主要终点
Insomnia

研究概览

简要总结

The main purpose of this project is to conduct a prospective cohort study in order to better understand the importance of insomnia symptoms in patients referred to interdisciplinary rehabilitation due to chronic pain. Moreover, this project will also raise awareness on how insomnia symptoms, alone, and in interplay with factors such as function, psychological distress, physical activity, and fatigue impact on patient's prognosis and work ability. Our aim is that this knowledge can be used to design new interventions and improve rehabilitation programs for this patient group.

详细描述

Insomnia is a vast problem among patients with chronic musculoskeletal pain. Despite the close relation between pain and sleep, sleep quality has received little attention in rehabilitation programs for patients with pain. So far, there is a lack of studies investigating the association between insomnia and chronic pain in patients referred to interdisciplinary rehabilitation. Identifying subgroups of the population with higher burden of poor sleep will aid clinicians to tailor treatment and prevention strategies. Moreover, knowledge on how insomnia symptoms fluctuate throughout the rehabilitation program and how insomnia symptoms interact with factors such as mental distress, physical activity, and fatigue impact on patient's recovery (e.g., the prognosis of pain, quality of life, and work participation) can be used to develop and implement more successful rehabilitation programs.

This is a cohort study primarily designed to address sleep problems in patients referred for pain rehabilitation by using questionnaire data from the rehabilitation centers linked to registry data. This study will constitute both a cross-sectional survey among patients referred to rehabilitation before they participate in rehabilitation. In addition to questionnaires, administrative data and clinical data, these data will be linked to national health registries on prescriptions, health care use and sickness absence. Potential participants are patients referred to rehabilitation at five different Unicare rehabilitation centers in Norway (Unicare Helsefort, Unicare Coperio, Unicare Hokksund, Unicare Friskvern and Unicare Jeløy) due to long-term pain complaints.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Take part in rehabilitation for long-term pain complaints at one of the five centers
  • Consented to research

排除标准

  • 未提供

结局指标

主要结局

Insomnia

时间窗: Baseline

Measured by Insomnia severity index (ISI)

Pain intensity

时间窗: Baseline

Measured by visual analogue scale (0 to 100 scale)

次要结局

  • Symptoms of anxiety and depression(Baseline)
  • Function(Baseline)
  • Health care use(Up to five years before rehabilitation and one year after rehabilitation)
  • Workability(Baseline)
  • Prescriptions(Up to five years before rehabilitation and one year after rehabilitation)
  • Sickness absence(Up to five years before rehabilitation and one year after rehabilitation)
  • Fatigue(Baseline)
  • Health-related quality of life(Baseline)
  • Physical activity(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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