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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.
Although preoperative sleep disturbance is associated with poorer acute postoperative pain control, as well as development of chronic postsurgical pain, only very limited attempts have been made to target preoperative sleep to achieve improved postoperative outcomes. This study addresses two chronic pain populations, TKA and THA patients, that suffer severely due to both sleep disturbance and painful symptoms. Patients who meet eligibility criteria, including insomnia severity index score >10 and confirmed DSM-V criteria for persistent insomnia disorder, will be randomized to a brief, hybrid version of CBT-I or sleep education therapy over a 4-week period, before surgery. The CBT-I will focus on the two components which have shown the highest efficacy for sleep improvement, sleep restriction therapy and stimulus control. The CBT-I treatment will be administered in self-guided digital format with addition of telehealth video-consultations with a psychologist one time per week. The sleep education therapy will also be provided in a hybrid format, including digital sessions and video-consultations with a research nurse. There will also be a booster session 1-2 weeks postoperative for both interventions. Participants will be carefully evaluated during on-site visits two times preoperative, pre- and post-intervention, and one time 6 months postoperative. During on-site visits, participants will complete multiple questionnaires (covering pain, pain catastrophizing, mental health, physical function, activity etc), undergo digital cognitive testing, quantitative sensory testing (QST, to determine pain detection thresholds to different stimuli, assess temporal summation, pain inhibitory capacity), provide blood samples, and initiate actigraphy (objective assessment of sleep continuity measures). In addition to the on-site visits, participants will complete questionnaires remotely 3 and 12 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive behavioral therapy for insomnia (CBT-I) | Experimental | The CBT-I treatment will be administered in self-guided digital format over 4 weeks with addition of telehealth video-consultations with a psychologist one time per week. The CBT-I will focus on sleep restriction therapy and stimulus control, which have shown the highest efficacy for sleep improvement among components typically incorporated. A booster session will be provided 1-2 weeks postoperative. |
|
| Sleep education therapy (SET) | Active Comparator | The sleep education therapy will be administered in self-guided digital format over 4 weeks with addition of telehealth video-consultations with a research nurse one time per week. The SET will focus on sleep physiology, different sleep disturbances and sleep hygiene measures. A booster session will be provided 1-2 weeks postoperative. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral therapy for insomnia (CBT-I) | Behavioral | Hybrid CBT-I (self-guided digital format focusing on sleep restriction therapy and stimulus control + telehealth video-consultations with psychologist) |
| Measure | Description | Time Frame |
|---|---|---|
| Acute postoperative pain intensity | Average pain intensity (NRS 0 - 10) over the past 24 h rated each morning, averaged over 7 days | First 7 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Up to 2 weeks postoperative |
| Acute postoperative opioid consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity | International physical activity questionnaire short form (IPAQ-sf) | Up to 6 months postoperative |
| Change in pain catastrophizing | Pain catastrophizing scale (PCS) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin F Bjurström, MD, PhD | Contact | +46739512728 | martin.flores.bjurstrom@uu.se |
| Name | Affiliation | Role |
|---|---|---|
| Martin F Bjurström, MD, PhD | Uppsala University / Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgical Sciences, Uppsala University | Recruiting | Uppsala | Uppland | 75185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40738630 | Derived | Bjurstrom MF, Bothelius K, Maathz P, Jernelov S, Kraepelien M, Rosenstrom AHC, Niklasson A, Smith MT, Olmstead R, Irwin MR, Finan PH, Kosek E. Randomised, controlled clinical trial evaluating the effects of preoperative insomnia treatment on postoperative pain control and recovery: a protocol for the Promoting Sleep to Alleviate Pain-Arthroplasty (PROSAP-A) trial. BMJ Open. 2025 Jul 30;15(7):e099785. doi: 10.1136/bmjopen-2025-099785. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010003 | Osteoarthritis |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Sleep education therapy (SET) | Behavioral | Self-guided digital sleep education (sleep hygiene, sleep physiology, sleep disturbances etc) + telehealth video-consultations with research nurse |
|
Oral morphine mg equivalents (OMEQs) |
| Postoperative day (POD) 1 and POD1-7 |
| Recovery in the acute postoperative phase | Quality of recovery (QoR) 15 score | First 7 postoperative days |
| Long-term postoperative sleep quality | insomnia severity index | Up to 12 months postoperative |
| Postoperative objective sleep continuity | actigraphic sleep efficiency [SE] | Up to 6 months postoperative |
| Pain intensity 6 months postoperative | Average pain intensity (NRS 0 - 10) over the past 24 h rated each morning, averaged over 7 days | 6 months postoperative |
| Change in pain measures from baseline | BPI pain severity and pain interference score, QoR-15 pain score, WOMAC OA pain score | Up to 12 months postoperative |
| Changes in quantitative sensory testing (QST) measures of pain | Pressure pain threshold, temporal summation, conditioned pain modulation, cold pressor test | Up to 6 months postoperative |
| Change in cognitive function | Digital cognitive testing (Mindmore platform) incl. memory, attention and processing speed, executive functions | Up to 6 months postoperative |
| Change in anxiety from baseline | Generalized anxiety disorder 7 (GAD-7) score | Up to 6 months postoperative |
| Change in depression from baseline | Patient health questionnaire 9 (PHQ-9) score | Up to 6 months postoperative |
| Change in quality of life | EuroQol 5 dimension 5 level (EQ-5D-5L), RAND-36 | Up to 6 months postoperative |
| Change in health-related function | EQ-5D-5L, RAND-36 | Up to 6 months postoperative |
| Change in osteoarthritis-related symptoms | WOMAC OA | Up to 12 months postoperative |
| Up to 6 months postoperative |
| Change in kinesiophobia | Tampa scale of kinesiophobia (TSK) | Up to 6 months postoperative |
| Change in subjective pain sensitivity | Pain sensitivity questionnaire (PSQ) | Up to 6 months postoperative |
| Fibromyalgia severity score | Sum of widespread pain index + symptom severity scale (ACR 2016) | Up to 6 months postoperative |
| Pain-related acceptance | Chronic pain acceptance questionnaire (CPAQ-8) | Up to 6 months postoperative |
| Changes in blood biomarkers | Inflammatory mediators, monoamine metabolites, coagulation system etc | Up to 6 months postoperative |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |