Preoperative Sleep-promotion to Achieve Improved Postoperative Pain Control and Recovery: a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Acute postoperative pain intensity
研究概览
简要总结
PROSAP-A is a perioperative randomized, controlled trial with a 12-month follow-up period after total knee arthroplasty (TKA) or total hip arthroplasty (THA), aiming to investigate both acute and long-term postoperative effects of preoperative sleep-promotion. Participants with clinically significant insomnia symptoms will be randomized to a brief, hybrid version of cognitive behavioral therapy for insomnia (CBT-I) or sleep education therapy, administered over a 4-week period, prior to surgery. The primary objective is to evaluate effects of preoperative sleep-promotion on acute postoperative pain control. Secondary objectives include evaluation of postoperative sleep, recovery, mental health, cognitive function and alterations in blood biomarkers.
详细描述
Although preoperative sleep disturbance is associated with poorer acute postoperative pain control, as well as development of chronic postsurgical pain, only very limited attempts have been made to target preoperative sleep to achieve improved postoperative outcomes. This study addresses two chronic pain populations, TKA and THA patients, that suffer severely due to both sleep disturbance and painful symptoms. Patients who meet eligibility criteria, including insomnia severity index score >10 and confirmed DSM-V criteria for persistent insomnia disorder, will be randomized to a brief, hybrid version of CBT-I or sleep education therapy over a 4-week period, before surgery. The CBT-I will focus on the two components which have shown the highest efficacy for sleep improvement, sleep restriction therapy and stimulus control. The CBT-I treatment will be administered in self-guided digital format with addition of telehealth video-consultations with a psychologist one time per week. The sleep education therapy will also be provided in a hybrid format, including digital sessions and video-consultations with a research nurse. There will also be a booster session 1-2 weeks postoperative for both interventions. Participants will be carefully evaluated during on-site visits two times preoperative, pre- and post-intervention, and one time 6 months postoperative. During on-site visits, participants will complete multiple questionnaires (covering pain, pain catastrophizing, mental health, physical function, activity etc), undergo digital cognitive testing, quantitative sensory testing (QST, to determine pain detection thresholds to different stimuli, assess temporal summation, pain inhibitory capacity), provide blood samples, and initiate actigraphy (objective assessment of sleep continuity measures). In addition to the on-site visits, participants will complete questionnaires remotely 3 and 12 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years
- •insomnia severity index score >10
- •fulfill DSM-V criteria for persistent insomnia disorder
- •average pain numerical rating scale (NRS) score ≥4 (scale 0 - 10) and/or movement-related pain NRS score ≥4 after 5 minutes walking
- •scheduled to undergo primary (first-time, i.e., not revision surgery) TKA or THA due to osteoarthritis
排除标准
- •uncontrolled medical disorders
- •nightshift work
- •ongoing major depressive disorder, bipolar disorder, psychotic disorder, substance dependence
- •current history or high likelihood of primary sleep disorders (other than insomnia), including obstructive sleep apnea syndrome, narcolepsy, nocturnal myoclonus
- •severely impaired vision (precluding ability to take part of study interventions)
研究组 & 干预措施
Cognitive behavioral therapy for insomnia (CBT-I)
The CBT-I treatment will be administered in self-guided digital format over 4 weeks with addition of telehealth video-consultations with a psychologist one time per week. The CBT-I will focus on sleep restriction therapy and stimulus control, which have shown the highest efficacy for sleep improvement among components typically incorporated. A booster session will be provided 1-2 weeks postoperative.
干预措施: Cognitive behavioral therapy for insomnia (CBT-I) (Behavioral)
Sleep education therapy (SET)
The sleep education therapy will be administered in self-guided digital format over 4 weeks with addition of telehealth video-consultations with a research nurse one time per week. The SET will focus on sleep physiology, different sleep disturbances and sleep hygiene measures. A booster session will be provided 1-2 weeks postoperative.
干预措施: Sleep education therapy (SET) (Behavioral)
结局指标
主要结局
Acute postoperative pain intensity
时间窗: First 7 postoperative days
Average pain intensity (NRS 0 - 10) over the past 24 h rated each morning, averaged over 7 days
Acute postoperative pain intensity
时间窗: First 7 postoperative days
Average pain intensity (NRS 0 - 10) over the past 24 h rated each morning, averaged over 7 days
次要结局
- Change in osteoarthritis-related symptoms(Up to 12 months postoperative)
- Pre- and acute postoperative change in sleep measures from baseline(Up to 2 weeks postoperative)
- Acute postoperative opioid consumption(Postoperative day (POD) 1 and POD1-7)
- Recovery in the acute postoperative phase(First 7 postoperative days)
- Long-term postoperative sleep quality(Up to 12 months postoperative)
- Postoperative objective sleep continuity(Up to 6 months postoperative)
- Pain intensity 6 months postoperative(6 months postoperative)
- Change in pain measures from baseline(Up to 12 months postoperative)
- Changes in quantitative sensory testing (QST) measures of pain(Up to 6 months postoperative)
- Change in cognitive function(Up to 6 months postoperative)
- Change in anxiety from baseline(Up to 6 months postoperative)
- Change in depression from baseline(Up to 6 months postoperative)
- Change in quality of life(Up to 6 months postoperative)
- Change in health-related function(Up to 6 months postoperative)
- Pre- and acute postoperative change in sleep measures from baseline(Up to 2 weeks postoperative)
- Acute postoperative opioid consumption(Postoperative day (POD) 1 and POD1-7)
- Postoperative objective sleep continuity(Up to 6 months postoperative)
- Recovery in the acute postoperative phase(First 7 postoperative days)
- Changes in quantitative sensory testing (QST) measures of pain(Up to 6 months postoperative)
- Change in cognitive function(Up to 6 months postoperative)
- Change in anxiety from baseline(Up to 6 months postoperative)
- Change in depression from baseline(Up to 6 months postoperative)
- Change in quality of life(Up to 6 months postoperative)
- Change in health-related function(Up to 6 months postoperative)
- Change in osteoarthritis-related symptoms(Up to 12 months postoperative)
- Long-term postoperative sleep quality(Up to 12 months postoperative)
- Pain intensity 6 months postoperative(6 months postoperative)
- Change in pain measures from baseline(Up to 12 months postoperative)