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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Department of Surgical Sciences, Uppsala University
RECRUITING
Uppsala
Contact Information
Primary
Martin F Bjurström, MD, PhD
martin.flores.bjurstrom@uu.se
+46739512728
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2030-12
Participants
Target number of participants: 100
Treatments
Experimental: 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.
Active_comparator: 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.
Sponsors
Leads: Uppsala University

This content was sourced from clinicaltrials.gov

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