Empowered Relief for Chronic Pain After Cesarean Delivery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a special session called Empowered Relief to determine its effectiveness in reducing chronic pain 12 weeks after a cesarean delivery. The session consists of a one-time, two-hour class that teaches pain relief skills, offers pain education, and provides a personalized plan and app for daily use. Participants will continue their usual postpartum care. Women experiencing moderate to severe pain six weeks after a C-section and who are part of the Stanford Healthcare system may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to access innovative pain relief strategies and contribute to valuable research.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team for guidance.
What prior data suggests that the Empowered Relief session is safe for postpartum women?
Research has shown that Empowered Relief is generally easy to handle. Studies comparing it to cognitive behavioral therapy (CBT) have found Empowered Relief to be equally safe. Both treatments proved more effective than regular health education in reducing pain. Participants reported no major side effects from Empowered Relief, suggesting it is a safe method for managing pain, despite not being a traditional medication.12345
Why are researchers excited about this trial?
Empowered Relief is unique because it offers a non-pharmaceutical approach to managing chronic pain after a cesarean delivery. Unlike standard treatments that often rely on medications like opioids or non-steroidal anti-inflammatory drugs (NSAIDs), Empowered Relief is a single, 2-hour session that teaches participants pain management skills and provides them with tools like a binaural app for daily use. Researchers are excited about this approach because it empowers patients to manage their pain through education and personalized strategies, potentially reducing the reliance on medication and minimizing side effects.
What evidence suggests that the Empowered Relief session is effective for chronic pain after cesarean delivery?
This trial will compare the effectiveness of Empowered Relief, a 2-hour, one-time class, with standard postpartum care for managing chronic pain after cesarean delivery. Studies have shown that Empowered Relief can improve chronic pain and enhance quality of life. In one study, adults who attended this class reported noticeable improvements in their pain. The class teaches pain management through education, exercises, and personalized plans. Participants also receive a special app for daily stress and pain management. Overall, research suggests that Empowered Relief could effectively reduce chronic pain, especially for those recovering from a cesarean delivery.16789
Who Is on the Research Team?
Pervez Sultan, MBChB, FRCA, MD(Res)
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for postpartum women who had a cesarean delivery at Stanford Healthcare, are fluent in English, over 18 years old, and have ongoing moderate/severe pain (≥4/10) at 6 weeks postpartum. They must be able to follow the study plan and join video meetings using a smart device. Women with chronic pain before pregnancy or cognitive impairments that affect comprehension or participation are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants attend a 2-hour Empowered Relief session at the beginning of the study period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Empowered Relief
Trial Overview
The trial studies 'Empowered Relief,' a one-time session designed to teach pain relief skills to manage chronic pain after cesarean delivery. The effect of this intervention on reducing chronic pain will be evaluated at 12 weeks post-delivery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will attend an Empowered Relief session at the beginning of the study period. Empowered Relief is a 2-hour one session pain relief skills intervention that is delivered to patients by a certified instructor using a standardized treatment manual and slide deck. Content includes completion of a pain survey, pain neuroscience education, information on pain and stress responses, experiential exercises, information on three core pain management skills, completion of a personalized plan for empowered relief, and receipt of a binaural app for daily use. Standard of care will be maintained for all participants, and supplemented with Empowered Relief. Pain management is not a factor for inclusion/exclusion criteria and patients will continue their pain management as prescribed and directed by their provider
Participants will follow their current standard of care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
Efficacy of a Single-Session “Empowered Relief” Zoom- ...
Among adults with chronic pain, this single-session, Zoom-delivered, skills-based pain class resulted in clinically significant improvement across a range of ...
Empowered Relief for Chronic Pain After Cesarean Delivery
The purpose of this study is to study the effect of a pain relief skills session (Empowered Relief) on chronic pain incidence at 12 weeks post cesarean delivery ...
Zoom-Delivered Empowered Relief for Chronic Pain - PubMed
Empowered Relief (ER), a 2-hour, single-session pain relief skills class, can improve pain and quality of life among patients with chronic pain ...
Research | Pain Relief Innovations Lab | Stanford Medicine
This NIH-funded study is a 3-arm randomized controlled study that is testing the comparative efficacy of (1) "Empowered Relief," (2) 8-week cognitive behavioral ...
5.
pcori.org
pcori.org/research-results/2021/comparing-effectiveness-two-online-programs-treating-chronic-painComparing the Effectiveness of Two Online Programs for ...
The project compares the effectiveness of two different online programs for treating chronic pain. Who will this research inform?
a comparison of outcomes at 6-month Follow-up for ... - PubMed
Results: Empowered Relief remained non-inferior to CBT on most outcomes, whereas both ER and CBT remained superior to HE on most outcomes.
The effectiveness and safety of complementary health ...
Two trials of massage found a reduction in pain following caesarean birth within the first 24 h post birth (MD -2.64, 95–2.82 to -2.46, 184 women, I2 0%), and ...
Pain Relief Skills + Education for Cesarean Section ...
The purpose of this study is to study the effect of a pain relief skills session (Empowered Relief) and educational content on global postpartum recovery at 12 ...
Patient and Provider Perspectives on Cesarean Delivery ...
Neuraxial anesthesia is considered the gold standard for cesarean delivery, because it provides more effective postoperative pain relief than general anesthesia ...
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