Promoting Sleep to Alleviate Pain - Arthroplasty

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUppsala University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators