Promoting Sleep to Alleviate Pain - Arthroplasty
Preoperative Sleep-promotion to Achieve Improved Postoperative Pain Control and Recovery: a Randomized, Controlled Trial
Uppsala University
100 participants
Sep 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria5
- 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)
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Interventions
Hybrid CBT-I (self-guided digital format focusing on sleep restriction therapy and stimulus control + telehealth video-consultations with psychologist)
Self-guided digital sleep education (sleep hygiene, sleep physiology, sleep disturbances etc) + telehealth video-consultations with research nurse
Locations(1)
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NCT06145516