RecruitingNot ApplicableNCT06145516

Promoting Sleep to Alleviate Pain - Arthroplasty

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


Sponsor

Uppsala University

Enrollment

100 participants

Start Date

Sep 1, 2025

Study Type

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Cognitive behavioral therapy for insomnia (CBT-I) and a behavioral approach called Sleep education therapy (SET) for people with insomnia, osteoarthritis, hip, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 100 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive behavioral therapy for insomnia (CBT-I)

Hybrid CBT-I (self-guided digital format focusing on sleep restriction therapy and stimulus control + telehealth video-consultations with psychologist)

BEHAVIORALSleep education therapy (SET)

Self-guided digital sleep education (sleep hygiene, sleep physiology, sleep disturbances etc) + telehealth video-consultations with research nurse


Locations(1)

Department of Surgical Sciences, Uppsala University

Uppsala, Uppland, Sweden

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NCT06145516


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