Empowered Relief for Postoperative Pain

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Overseen ByGuillermina Ferrea, MD, MSc
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 explores a new method to manage severe pain for women who have just undergone a cesarean delivery. The study tests "Empowered Relief," a single-session pain management class that includes techniques like relaxation and deep breathing, alongside regular postpartum care. Women who have had a cesarean section at Stanford Healthcare and experience severe pain during their hospital stay might be suitable candidates. The researchers aim to assess the effectiveness of this approach and whether participants find it helpful. Participants will be monitored for 12 weeks after delivery. As an unphased trial, this study offers participants the chance to contribute to innovative pain management research that could benefit future mothers.

What prior data suggests that the Empowered Relief intervention is safe for postpartum patients?

Research has shown that the "Empowered Relief" program is generally easy for participants to handle. One study found that a single 2-hour class teaching pain relief skills was as effective as an 8-session cognitive-behavioral therapy (CBT) program for managing pain. This indicates that the program is not only effective but also manageable for patients.

Reports of negative effects from the "Empowered Relief" program were minimal, suggesting it is safe for most people. The program focuses on teaching about pain and skills like relaxation and deep breathing, which are safe and non-invasive. Overall, evidence supports that "Empowered Relief" is a safe and effective way to manage pain without significant risk.12345

Why are researchers excited about this trial?

Empowered Relief is unique because it combines cognitive-behavioral pain management techniques with relaxation resources to address postoperative pain. Unlike traditional pain management options that rely heavily on medications like opioids or NSAIDs, Empowered Relief provides patients with skills such as deep breathing, reframing, and the development of a personalized pain management plan. Researchers are excited about this approach because it empowers individuals to manage their pain with fewer medications, potentially reducing the risk of side effects and dependency associated with long-term drug use. Additionally, the inclusion of digital tools like a smartphone relaxation app makes it accessible and easy to integrate into everyday life.

What evidence suggests that Empowered Relief is effective for managing postoperative pain?

Research has shown that programs like Empowered Relief can help manage pain after surgery. In this trial, participants will receive a single 120-minute Empowered Relief session in addition to standard postpartum care. Studies have found that learning about pain and using techniques to change thoughts about it can reduce pain and lessen the need for painkillers. Empowered Relief includes methods like relaxation and deep breathing, which are known to help with pain. Evidence also suggests these methods can foster positive beliefs about pain and lower the chance of short-term pain becoming long-term. Although specific data on Empowered Relief for pain after childbirth is limited, research supports its techniques in similar situations.678910

Are You a Good Fit for This Trial?

This trial is for women who have just had a cesarean section and are experiencing severe pain while still in the hospital after delivery. Participants must be able to take part during their postpartum hospital stay.

Inclusion Criteria

Complete informed consent
Viable birth (singleton or multiple gestation)
Postpartum woman who delivered by cesarean within the Stanford Healthcare system
See 7 more

Exclusion Criteria

Medical or clinical instability precluding safe participation in study procedures or intervention
I do not have cognitive or psychological issues that prevent me from understanding or participating.
I am under 18 years old.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

At screening

Inpatient Intervention

Participants receive a single 120-minute Empowered Relief session during the inpatient postpartum period

Day 1 ± 5 days
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up assessments at 3, 6, and 12 weeks postpartum

12 weeks
3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Empowered Relief

Trial Overview

The study is testing whether a single-session pain management class called Empowered Relief, given alongside usual care, helps with severe pain after C-section compared to usual care alone. Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Empowered ReliefExperimental Treatment1 Intervention
Group II: Standard Postpartum 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+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

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

Collaborator

Trials
2,103
Recruited
2,760,000+

Citations

Empowered Relief and Exercise Rehabilitation for People ...

The daily outcome measures represent four predefined domains: pain-related beliefs, expected pain responses to exercise, actual pain responses ...

Chronic pain after cesarean delivery: What do we know ...

Large cohort studies show that 70-80% of women experience moderate to severe pain in the first 48 hours, and up to 15% report pain that interferes with ...

Web-Based Nursing Intervention for Self-Management of Pain ...

We developed a Web-based nursing intervention to influence patient's involvement in postoperative pain management. The intervention (SOULAGE- ...

Perioperative Behavioral Interventions for Pain Relief | PDF

This scoping review examines the efficacy of perioperative behavioral interventions for pain relief and opioid reduction after surgery.

Enhanced Pain Education for Post-Surgery Pain in Children

The study compares standard post-surgery pain management to the same care plus extra education on what kind of pain to expect and how it will be managed. The ...

Post-Operative Pain after Caesarean Delivery

Response rate was 86.2%. (46.1%) reported severe pain. Mean pain intensity in the first 24 hours after surgery was 7±2 out of 10 on the VAS. ...

a-multimodal-analgesic-pathway-improves-postpartum- ...

Results: Prior to analgesia protocol implementation, pain management scores were below the desired benchmark of 78%. Post-implementation, ...

“Empowered Relief” Program Equips Patients With ...

Findings from our study suggest that a one-time 2-hour pain relief skills class (“Empowered Relief”) was non-inferior to 8-session CBT for ...

Are NSAIDs (Single Dose) Effective at Reducing Perineal ...

RESULTS: · More women on single dose NSAID compared to placebo achieved adequate pain relief at four hours (risk ratio 1.91, 95% CI 1.64 to 2.23; ...