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Promoting Sleep to Alleviate Pain - Arthroplasty

RecruitingNAAges 18 Years - 100 YearsAllUppsala University
NCT06145516 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Cognitive behavioral therapy for insomnia (CBT-I)
  • Sleep education therapy (SET)
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Where

1 site
Department of Surgical Sciences, Uppsala University
Uppsala, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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