Promoting Sleep to Alleviate Pain - Arthroplasty

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

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* severely impaired vision (precluding ability to take part of study interventions)

Conditions7

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