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| Name | Class |
|---|---|
| Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empowered Relief (ER) | Experimental | Behavioral: Empowered Relief A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.The ER session will be done between 4 to 8 weeks before the surgery. All treatment sessions will be conducted in person, in a meeting room of the CIUSSS de l'Estrie-CHUS |
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| Waitlist Control (WLC) | No Intervention | Participants randomized to the waitlist control arm will be instructed to continue with their usual medical care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empowered Relief (ER) consists of a single-session, 2-hour group class. | Behavioral | ER is rooted in cognitive behavioral theory and incorporates pain education, self-regulatory skills and mindfulness principle |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Less than 7 days Post ER session |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-weeks post-surgery |
| Pain Catastrophizing Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Pain medication | Pain medication use will be assessed using a self-report medication questionnaire asking participants which medications they have used to relieve pain in the past 2 weeks. Medication categories include: Acetaminophen, Non-steroidal anti-inflammatory drugs (NSAIDs), Muscle relaxants, Opioid/narcotic analgesics, Neuropathic pain medications (e.g., gabapentin, pregabalin), Antidepressants used for pain, Cannabis and Other (specified by participant). For each category, participants indicate frequency of use: As needed (occasionally), Regularly, Used previously but stopped. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIUSSSE de l'Estrie CHUS | Recruiting | Sherbrooke | Quebec | J1H 5N4 | Canada |
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Clinical trial randomizing to one of two groups: (1) standard care; and (2) single-session pain relief skills intervention for chronic pain (Empowered Relief)
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Participants and research staff will know arm assignment. Co-investigators, project statisticians, and the protocol director at each study site will remain blinded until final assessment.
Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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" | 3-months post-surgery |
| Baseline |
| Pain medication | Pain medication use will be assessed using a self-report medication questionnaire asking participants which medications they have used to relieve pain in the past 2 weeks. Medication categories include: Acetaminophen, Non-steroidal anti-inflammatory drugs (NSAIDs), Muscle relaxants, Opioid/narcotic analgesics, Neuropathic pain medications (e.g., gabapentin, pregabalin), Antidepressants used for pain, Cannabis and Other (specified by participant). For each category, participants indicate frequency of use: As needed (occasionally), Regularly, Used previously but stopped. | 6-weeks post-surgery |
| Pain medication | Pain medication use will be assessed using a self-report medication questionnaire asking participants which medications they have used to relieve pain in the past 2 weeks. Medication categories include: Acetaminophen, Non-steroidal anti-inflammatory drugs (NSAIDs), Muscle relaxants, Opioid/narcotic analgesics, Neuropathic pain medications (e.g., gabapentin, pregabalin), Antidepressants used for pain, Cannabis and Other (specified by participant). For each category, participants indicate frequency of use: As needed (occasionally), Regularly, Used previously but stopped. | 3-months post-surgery |
| Pain management method | Use of non-pharmacological pain management approaches will be assessed using a self-report questionnaire asking participants which non-medication resources they consulted or used to relieve pain during the past month. Categories include: Physiotherapy, Occupational therapy, Massage therapy, Psychology services, Self-care strategies (e.g., ice, heat, self-massage), and Other (specified by participant). Participants will indicate frequency of use for each category: 1-2 times, 3-10 times, More than 10 times. | 6-weeks post-surgery |
| Pain management method | Use of non-pharmacological pain management approaches will be assessed using a self-report questionnaire asking participants which non-medication resources they consulted or used to relieve pain during the past month. Categories include: Physiotherapy, Occupational therapy, Massage therapy, Psychology services, Self-care strategies (e.g., ice, heat, self-massage), and Other (specified by participant). Participants will indicate frequency of use for each category: 1-2 times, 3-10 times, More than 10 times. | 3-months post-surgery |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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