Empowered Relief for Chronic Pain After Cesarean Delivery

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

PS

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

Any postpartum woman who has had a cesarean delivery in the Stanford Healthcare system with a viable birth
English fluency
Ability to adhere to and complete study protocols
See 3 more

Exclusion Criteria

Chronic pain prior to pregnancy
Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend a 2-hour Empowered Relief session at the beginning of the study period

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks
Thrice weekly assessments via SMS

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: 1-Session pain relief skills session (Empowered Relief)Experimental Treatment1 Intervention
Group II: Control arm: Postpartum Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

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 DeliveryThe 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 ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40068160
Zoom-Delivered Empowered Relief for Chronic Pain - PubMedEmpowered 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 MedicineThis 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 ...
Comparing 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?
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38288134/
a comparison of outcomes at 6-month Follow-up for ... - PubMedResults: 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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