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Studies

Interventional Recruiting

NCT06145516 on ClinicalTrials.gov

Promoting Sleep to Alleviate Pain - Arthroplasty

Official title: Preoperative Sleep-promotion to Achieve Improved Postoperative Pain Control and Recovery: a Randomized, Controlled Trial

  • Sponsor: Uppsala University
  • Enrollment: 100 (Estimated)
  • Study start: 2025-09-01 (Actual)
  • Primary completion: 2029-12-01 (Estimated)
  • Study completion: 2030-12-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Double (Investigator, Outcomes Assessor)
  • PrimaryPurpose: Prevention

Brief 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.

Conditions

  • Osteoarthritis, Knee
  • Osteoarthritis, Hip
  • Insomnia
  • Surgery
  • Pain, Postoperative
  • Postoperative Complications

Intervention / Treatment

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

Primary Outcome Measures

  • Acute postoperative pain intensity (First 7 postoperative days)
    Average pain intensity (NRS 0 - 10) over the past 24 h rated each morning, averaged over 7 days

Countries

Sweden

Locations and Investigators

  • Department of Surgical Sciences, Uppsala University, Uppsala, Sweden (Recruiting)
    • Andrea Niklasson, M.D.
    • Martin F Bjurström, Associate Professor (Principal Investigator)

Study Officials