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.
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
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
Parallel
Cognitive behavioral therapy for insomnia (CBT-I)
BehavioralHybrid CBT-I (self-guided digital format focusing on sleep restriction therapy and stimulus control + telehealth video-consultations with psychologist)
Sleep education therapy (SET)
BehavioralSelf-guided digital sleep education (sleep hygiene, sleep physiology, sleep disturbances etc) + telehealth video-consultations with research nurse
Acute postoperative pain intensity
Average pain intensity (NRS 0 - 10) over the past 24 h rated each morning, averaged over 7 days
Pre- and acute postoperative change in sleep measures from baseline
insomnia severity index, Pittsburgh sleep quality index, actigraphic sleep continuity measures (sleep onset latency, total sleep time, wakefulness after sleep onset, sleep efficiency)
Acute postoperative opioid consumption
Oral morphine mg equivalents (OMEQs)
Recovery in the acute postoperative phase
Quality of recovery (QoR) 15 score
Long-term postoperative sleep quality
insomnia severity index
Change in physical activity
International physical activity questionnaire short form (IPAQ-sf)
Change in pain catastrophizing
Pain catastrophizing scale (PCS)
Change in kinesiophobia
Tampa scale of kinesiophobia (TSK)
Change in subjective pain sensitivity
Pain sensitivity questionnaire (PSQ)
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