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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empowered Relief (ER) consists of a single-session, 2-hour group class..
- Who it may be relevant to
- Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Behavioral Empowered Relief (ER) consists of a single-session, 2-hour group class.
ER is rooted in cognitive behavioral theory and incorporates pain education, self-regulatory skills and mindfulness principle
Primary outcome measures
- Pain Intensity and Interference [Time frame: 6-weeks post-surgery]
- Pain Intensity and Interference [Time frame: 3-months post-surgery]
- Treatment Acceptability [Time frame: Less than 7 days Post ER session]
Secondary outcome measures (12)
- Pain Catastrophizing Scale [Time frame: 6-weeks post-surgery]
- Pain Catastrophizing Scale [Time frame: 3-months post-surgery]
- Pain Self-Efficacy Questionnaire (PSEQ) [Time frame: 6-weeks post-surgery]
- Pain Self-Efficacy Questionnaire (PSEQ) [Time frame: 3-months post-surgery]
- General Self-Efficacy - Short Form 4a [Time frame: 6-weeks post-surgery]
- General Self-Efficacy - Short Form 4a [Time frame: 3-months post-surgery]
- PROMIS Short Form v1.0 - Depression - 8a [Time frame: 6-weeks post-surgery]
- PROMIS Short Form v1.0 - Depression - 8a [Time frame: 3-months post-surgery]
- PROMIS Short Form v1.0 - Anxiety - 8a [Time frame: 6-weeks post-surgery]
- PROMIS Short Form v1.0 - Anxiety - 8a [Time frame: 3-months post-surgery]
- PROMIS Short Form v1.0 - Sleep Disturbance 4a [Time frame: 6-weeks post-surgery]
- PROMIS Short Form v1.0 - Sleep Disturbance 4a [Time frame: 3-months post-surgery]
Eligibility criteria
Inclusion criteria
- 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+
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Canada · 1 center
- CIUSSSE de l'Estrie CHUS — Sherbrooke
Identifiers
NCT: NCT07392099 · CÉRCIUSSSEstrieCHUS_2025-5666