Comparison of the Efficacy of an Empowered Relief Single-Session Versus Standard Care for Reducing Postoperative Pain Following Elective Orthopedic Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Pain Intensity and Interference
研究概览
简要总结
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.
详细描述
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:
- Empowered Relief (ER): A single-session, 2-hour intervention based on cognitive behavioral therapy (CBT) principles, designed to teach patients pain self-management strategies.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain >4/10 for >3 months related to the surgical indication
- •French fluency
- •Ability to adhere to and complete study protocol
- •Males and females, 18+
排除标准
- •Participated in another project that may cause bias in the study results
- •Pain related to cancer
- •Cognitive impairment, non-French speaking, or factors that would preclude comprehension of material or full participation in ER
- •Previous participation in ER
研究组 & 干预措施
Empowered Relief (ER)
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
干预措施: Empowered Relief (ER) consists of a single-session, 2-hour group class. (Behavioral)
Waitlist Control (WLC)
Participants randomized to the waitlist control arm will be instructed to continue with their usual medical care.
结局指标
主要结局
Pain Intensity and Interference
时间窗: 6-weeks post-surgery
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.
Pain Intensity and Interference
时间窗: 3-months post-surgery
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.
Treatment Acceptability
时间窗: Less than 7 days Post ER session
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.
次要结局
- Pain Catastrophizing Scale(6-weeks post-surgery)
- Pain Catastrophizing Scale(3-months post-surgery)
- Pain Self-Efficacy Questionnaire (PSEQ)(6-weeks post-surgery)
- Pain Self-Efficacy Questionnaire (PSEQ)(3-months post-surgery)
- General Self-Efficacy - Short Form 4a(6-weeks post-surgery)
- General Self-Efficacy - Short Form 4a(3-months post-surgery)
- PROMIS Short Form v1.0 - Depression - 8a(6-weeks post-surgery)
- PROMIS Short Form v1.0 - Depression - 8a(3-months post-surgery)
- PROMIS Short Form v1.0 - Anxiety - 8a(6-weeks post-surgery)
- PROMIS Short Form v1.0 - Anxiety - 8a(3-months post-surgery)
- PROMIS Short Form v1.0 - Sleep Disturbance 4a(6-weeks post-surgery)
- PROMIS Short Form v1.0 - Sleep Disturbance 4a(3-months post-surgery)
- PROMIS Short Form v2.0 - Social Isolation 4a(6-weeks post-surgery)
- PROMIS Short Form v2.0 - Social Isolation 4a(3-months post-surgery)
- PROMIS Short Form v1.0 - Fatigue 4a(6-weeks post-surgery)
- PROMIS Short Form v1.0 - Fatigue 4a(3-months post-surgery)
- Short Assessment of Patient Satisfaction (SAPS)(3-months post-surgery)
研究者
Junie Carrière
Assistant Professor
Université de Sherbrooke