Reducing Chronic Pain Following Cesarean Delivery

NCT07799883 | Not Yet Recruiting

• 3 other identifiers: 84718R90HD118650K24DA053564
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will evaluate the feasibility and acceptability of delivering Empowered Relief (ER), a single-session pain relief skills class, to postpartum women with ongoing pain and/or pain interference following cesarean delivery. Participants will receive ER in addition to standard postpartum care and will be followed through 12 weeks postpartum.

Conditions

Chronic Pain; Cesarean Section Complications; Postpartum

Keywords

Empowered Relief; Postpartum Pain; Cesarean Section; Caesarean Section; Cesarean Delivery; Pain Interference; Pain Management; Chronic Pain; Chronic Postsurgical Pain; Postpartum

Outcome Measures

Primary Outcomes (1)

• Proportion of enrolled patients that complete the Empowered Relief session

  The proportion of enrolled patients that complete the single 120-minute Empowered Relief session.

  Within 2 weeks of enrollment

Secondary Outcomes (10)

• Proportion of screened patients who are eligible for the study

  During screening, at approximately 6 weeks postpartum

• Proportion of eligible patients that consent to study from those approached

  During screening and enrollment, at approximately 6 weeks postpartum

• Proportion of recruited patients who register for the Empowered Relief session

  Within 1 week of enrollment

• Proportion of recruited patients who attend the Empowered Relief session

  Within 2 weeks of baseline

• Treatment Appraisal score

  Immediately after the Empowered Relief session, up to 2 weeks post-treatment

Study Arms (1)

Empowered Relief

EXPERIMENTAL

Participants will receive a single 120-minute Empowered Relief session in addition to standard postpartum care. The session includes pain education and cognitive-behavioral pain management skills, including relaxation, deep breathing, reframing, and development of a personalized plan. Participants will also receive access to a smartphone relaxation resource (Calm Tool app, or a relaxation audio file if the app cannot be downloaded).

Behavioral: Empowered Relief

Interventions

Empowered Relief BEHAVIORAL

A single 120-minute pain relief skills class delivered by trained, certified instructors via Zoom or in person. The session includes pain education, cognitive behavioral skills including relaxation, deep breathing, and reframing, and completion of a personalized plan. Following the session, participants receive access to the Calm Tool smartphone relaxation app (or a binaural relaxation audio file if the app cannot be downloaded).

Empowered Relief

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Complete informed consent.
• Age 18 years or above.
• Postpartum woman who delivered by cesarean within the Stanford Healthcare system.
• Viable birth (singleton or multiple gestation).
• All maternal demographics and complications are eligible: parity, medical conditions (e.g., pre-eclampsia, gestational diabetes), and post-surgical complications (e.g., hysterectomy, ICU admission, extended hospital stay).
• All neonatal complications are eligible (e.g., NICU admission, extended hospital stay)
• Attend the 6-week postpartum clinic visit.
• Any pain intensity (numeric rating scale \[NRS\] \>0/10) and/or pain interference (PROMIS pain interference 8a score \>8) at 6 weeks postpartum.
• English fluency, with ability to read and write.
• Ability to adhere to and complete study procedures.
• Access to a smart device if attending ER session via Zoom.

You may not qualify if:

• Age under 18 years.
• Cognitive impairment or psychological factors that would preclude comprehension of study material or full participation.
• Unable or unwilling to provide informed consent.
• Chronic pain prior to pregnancy.

Sponsors & Collaborators

• Stanford University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Stanford Medicine Children's Health - Specialty Services, Welch Road

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Jethwa A, Nguyen N, Michel G, Simons LE, Rabbitts J, Panelli DM, Darnall BD, Sultan P. Use of a single pain coping skills session (Empowered Relief) for outpatient postpartum pain following cesarean delivery: a pilot feasibility study. Int J Obstet Anesth. 2026 Aug;67:105190. doi: 10.1016/j.ijoa.2026.105190. Epub 2026 Apr 28.

  PMID: 42349309 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Perioperative and Pain Medicine (Obstetrics)

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 14, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)