Improving sleep to reduce pain after joint surgery
Preoperative Sleep-promotion to Achieve Improved Postoperative Pain Control and Recovery: a Randomized, Controlled Trial
NA · Uppsala University · NCT06145516
This study is testing if helping people with insomnia sleep better before knee or hip surgery can reduce their pain after the operation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Uppsala University (other) |
| Locations | 1 site (Uppsala, Uppland) |
| Trial ID | NCT06145516 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of preoperative sleep promotion on pain control in patients undergoing total knee or hip arthroplasty. Participants with significant insomnia will be randomized to receive either cognitive behavioral therapy for insomnia (CBT-I) or sleep education therapy over a four-week period before their surgery. The study aims to evaluate both acute and long-term postoperative outcomes, including pain management, sleep quality, mental health, and cognitive function. Participants will be monitored through questionnaires and on-site visits at various stages of the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with significant insomnia symptoms who are scheduled for total knee or hip arthroplasty.
Not a fit: Patients with uncontrolled medical disorders, severe psychiatric conditions, or primary sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and recovery for patients undergoing joint replacement surgeries.
How similar studies have performed: While there is limited research specifically targeting preoperative sleep for postoperative outcomes, similar approaches in managing insomnia have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Uppsala, Uppland
- Department of Surgical Sciences, Uppsala University — Uppsala, Uppland, Sweden (RECRUITING)
Study contacts
- Principal investigator: Martin F Bjurström, MD, PhD — Uppsala University / Uppsala University Hospital
- Study coordinator: Martin F Bjurström, MD, PhD
- Email: martin.flores.bjurstrom@uu.se
- Phone: +46739512728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoarthritis, Knee, Osteoarthritis, Hip, Insomnia, Surgery, Pain, Postoperative, Postoperative Complications, osteoarthritis, total knee arthroplasty