The purpose of this study is to evaluate the efficacy and acceptability of the French-Canadian version of ER compared to standard care in reducing postoperative pain and improving recovery outcomes at 6-week and 3-month follow-ups after elective orthopedic surgery.
The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness and acceptability of two postoperative pain management approaches following elective orthopedic surgery: 1. Empowered Relief (ER): A single-session, 2-hour intervention based on cognitive behavioral therapy (CBT) principles, designed to teach patients pain self-management strategies. 2. Standard Care: Usual postoperative care without additional psychological intervention. The investigators aim to determine which approach is more effective and acceptable for patients in managing postoperative pain. Ultimately, this research aims to provide a low-cost, low-risk, widely accessible, and feasible intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
134
ER is rooted in cognitive behavioral theory and incorporates pain education, self-regulatory skills and mindfulness principle
CIUSSSE de l'Estrie CHUS
Sherbrooke, Quebec, Canada
RECRUITINGPain Intensity and Interference
The Brief Pain Inventory-short form measures both the intensity of pain and the interference of pain in various aspects of the patient's life. Patients rate their pain at its "worst," "least," "average," and "now" (current pain) over the past 24 hours. Ratings are provided on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine." Patients also assess how pain has interfered with seven aspects of their daily life: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Time frame: 6-weeks post-surgery
Pain Intensity and Interference
The Brief Pain Inventory-short form measures both the intensity of pain and the interference of pain in various aspects of the patient's life. Patients rate their pain at its "worst," "least," "average," and "now" (current pain) over the past 24 hours. Ratings are provided on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine." Patients also assess how pain has interfered with seven aspects of their daily life: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Time frame: 3-months post-surgery
Treatment Acceptability
Acceptability of the ER session will be assessed with the Acceptability Home-based questionnaire, a 8-item measure with a total score ranging from 0-48 with higher scores indicative of more acceptability.
Time frame: Less than 7 days Post ER session
Pain Catastrophizing Scale
Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.
Time frame: 6-weeks post-surgery
Pain Catastrophizing Scale
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Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.
Time frame: 3-months post-surgery
Pain Self-Efficacy Questionnaire (PSEQ)
The 10 item Pain Self-Efficacy Questionnaire (PSEQ) assesses self-efficacy using à 0 = "Not confident at all" to 6= "Completely confident" scale. Higher scores suggest a greater self-efficacy.
Time frame: 6-weeks post-surgery
Pain Self-Efficacy Questionnaire (PSEQ)
The 10 item Pain Self-Efficacy Questionnaire (PSEQ) assesses self-efficacy using à 0 = "Not confident at all" to 6= "Completely confident" scale. Higher scores suggest a greater self-efficacy.
Time frame: 3-months post-surgery
General Self-Efficacy - Short Form 4a
Compare treatment groups for self-efficacy using the PROMIS 4-item PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate higher levels of Self-Efficacy - Lower scores indicate lower levels of Self-Efficacy.
Time frame: 6-weeks post-surgery
General Self-Efficacy - Short Form 4a
Compare treatment groups for self-efficacy using the PROMIS 4-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate higher levels of Self-Efficacy - Lower scores indicate lower levels of Self-Efficacy.
Time frame: 3-months post-surgery
PROMIS Short Form v1.0 - Depression - 8a
Compare treatment groups for depression using the PROMIS 8-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate higher levels of Depression - Lower scores indicate lower levels of Depression.
Time frame: 6-weeks post-surgery
PROMIS Short Form v1.0 - Depression - 8a
Compare treatment groups for depression using the PROMIS 8-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate higher levels of Depression - Lower scores indicate lower levels of Depression.
Time frame: 3-months post-surgery
PROMIS Short Form v1.0 - Anxiety - 8a
Compare treatment groups for anxiety using the PROMIS 8-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate higher levels of Anxiety- Lower scores indicate lower levels of Anxiety.
Time frame: 6-weeks post-surgery
PROMIS Short Form v1.0 - Anxiety - 8a
Compare treatment groups for anxiety using the PROMIS 8-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate higher levels of Anxiety- Lower scores indicate lower levels of Anxiety.
Time frame: 3-months post-surgery
PROMIS Short Form v1.0 - Sleep Disturbance 4a
Compare treatment groups for sleep disturbance using the PROMIS 4-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate higher levels of Sleep disturbance - Lower scores indicate lower levels of Sleep disturbance.
Time frame: 6-weeks post-surgery
PROMIS Short Form v1.0 - Sleep Disturbance 4a
Compare treatment groups for sleep disturbance using the PROMIS 4-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate higher levels of Sleep disturbance - Lower scores indicate lower levels of Sleep disturbance.
Time frame: 3-months post-surgery
PROMIS Short Form v2.0 - Social Isolation 4a
Compare treatment groups for social isolation using the PROMIS 4-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate higher levels of Social isolation - Lower scores indicate lower levels of Social isolation.
Time frame: 6-weeks post-surgery
PROMIS Short Form v2.0 - Social Isolation 4a
Compare treatment groups for social isolation using the PROMIS 4-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate higher levels of Social isolation - Lower scores indicate lower levels of Social isolation.
Time frame: 3-months post-surgery
PROMIS Short Form v1.0 - Fatigue 4a
Compare treatment groups for fatigue using the PROMIS 4-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate higher levels of Fatigue - Lower scores indicate lower levels of Fatigue.
Time frame: 6-weeks post-surgery
PROMIS Short Form v1.0 - Fatigue 4a
Compare treatment groups for fatigue using the PROMIS 4-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate higher levels of Fatigue - Lower scores indicate lower levels of Fatigue.
Time frame: 3-months post-surgery
Short Assessment of Patient Satisfaction (SAPS)
The Short Assessment of Patient Satisfaction (SAPS) assesses patients' satisfaction regarding their health care with 7 items using a 4 likert scale from "very satisfied" to "very unsatisfied"
Time frame: 3-months post-surgery