Department of Surgical Sciences, Uppsala University
Uppsala, Uppland, 75185, Sweden
Location status: Recruiting
Location contact
Andrea Niklasson, M.D.
CONTACT
Martin F Bjurström, Associate Professor
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06145516
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Uppsala, Uppland, 75185, Sweden
Location status: Recruiting
Andrea Niklasson, M.D.
CONTACT
Martin F Bjurström, Associate Professor
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hybrid CBT-I (self-guided digital format focusing on sleep restriction therapy and stimulus control + telehealth video-consultations with psychologist)
Self-guided digital sleep education (sleep hygiene, sleep physiology, sleep disturbances etc) + telehealth video-consultations with research nurse
Time frame: First 7 postoperative days
Average pain intensity (NRS 0 - 10) over the past 24 h rated each morning, averaged over 7 days
Time frame: Up to 2 weeks postoperative
insomnia severity index, Pittsburgh sleep quality index, actigraphic sleep continuity measures (sleep onset latency, total sleep time, wakefulness after sleep onset, sleep efficiency)
Time frame: Postoperative day (POD) 1 and POD1-7
Oral morphine mg equivalents (OMEQs)
Time frame: First 7 postoperative days
Quality of recovery (QoR) 15 score
Time frame: Up to 12 months postoperative
insomnia severity index
Time frame: Up to 6 months postoperative
actigraphic sleep efficiency [SE]
Time frame: 6 months postoperative
Average pain intensity (NRS 0 - 10) over the past 24 h rated each morning, averaged over 7 days
Time frame: Up to 12 months postoperative
BPI pain severity and pain interference score, QoR-15 pain score, WOMAC OA pain score
Time frame: Up to 6 months postoperative
Pressure pain threshold, temporal summation, conditioned pain modulation, cold pressor test
Time frame: Up to 6 months postoperative
Digital cognitive testing (Mindmore platform) incl. memory, attention and processing speed, executive functions
Time frame: Up to 6 months postoperative
Generalized anxiety disorder 7 (GAD-7) score
Time frame: Up to 6 months postoperative
Patient health questionnaire 9 (PHQ-9) score
Time frame: Up to 6 months postoperative
EuroQol 5 dimension 5 level (EQ-5D-5L), RAND-36
Time frame: Up to 6 months postoperative
EQ-5D-5L, RAND-36
Time frame: Up to 12 months postoperative
WOMAC OA
Time frame: Up to 6 months postoperative
International physical activity questionnaire short form (IPAQ-sf)
Time frame: Up to 6 months postoperative
Pain catastrophizing scale (PCS)
Time frame: Up to 6 months postoperative
Tampa scale of kinesiophobia (TSK)
Time frame: Up to 6 months postoperative
Pain sensitivity questionnaire (PSQ)
Time frame: Up to 6 months postoperative
Sum of widespread pain index + symptom severity scale (ACR 2016)
Time frame: Up to 6 months postoperative
Chronic pain acceptance questionnaire (CPAQ-8)
Time frame: Up to 6 months postoperative
Inflammatory mediators, monoamine metabolites, coagulation system etc
Contact information is provided by the study sponsor or research team.
Uppsala University
Other
Preoperative Sleep-promotion to Achieve Improved Postoperative Pain Control and Recovery: a Randomized, Controlled Trial
Acronym: PROSAP-A
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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