Reducing Chronic Pain Following Cesarean Delivery

September 4, 2026 updated by: Pervez Sultan, Stanford University

A Pilot Feasibility Study of an Intervention to Reduce Chronic Pain Following Cesarean Delivery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford Medicine Children's Health - Specialty Services, Welch Road
        • Principal Investigator:
          • Pervez Sultan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Complete informed consent.
  2. Age 18 years or above.
  3. Postpartum woman who delivered by cesarean within the Stanford Healthcare system.
  4. Viable birth (singleton or multiple gestation).
  5. 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).
  6. All neonatal complications are eligible (e.g., NICU admission, extended hospital stay)
  7. Attend the 6-week postpartum clinic visit.
  8. Any pain intensity (numeric rating scale [NRS] >0/10) and/or pain interference (PROMIS pain interference 8a score >8) at 6 weeks postpartum.
  9. English fluency, with ability to read and write.
  10. Ability to adhere to and complete study procedures.
  11. Access to a smart device if attending ER session via Zoom.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Empowered Relief
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of enrolled patients that complete the Empowered Relief session
Time Frame: Within 2 weeks of enrollment
The proportion of enrolled patients that complete the single 120-minute Empowered Relief session.
Within 2 weeks of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of screened patients who are eligible for the study
Time Frame: During screening, at approximately 6 weeks postpartum
The proportion of screened patients that meet the study eligibility criteria.
During screening, at approximately 6 weeks postpartum
Proportion of eligible patients that consent to study from those approached
Time Frame: During screening and enrollment, at approximately 6 weeks postpartum
The proportion of eligible patients who provide informed consent and enroll in the study.
During screening and enrollment, at approximately 6 weeks postpartum
Proportion of recruited patients who register for the Empowered Relief session
Time Frame: Within 1 week of enrollment
The 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
Time Frame: Within 2 weeks of baseline
The proportion of recruited patients who attend an Empowered Relief session.
Within 2 weeks of baseline
Participant Treatment Skills Use Scale score
Time Frame: Weekly from completion of the Empowered Relief session through 12 weeks postpartum
Use of skills learned during the Empowered Relief intervention assessed using the 5-item Participant Treatment Skills Use Scale. Total scores range from 0 to 25, with higher scores indicating greater use of treatment skills.
Weekly from completion of the Empowered Relief session through 12 weeks postpartum
Adherence to Study Procedures: completion rate of scheduled surveys
Time Frame: From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
The percentage of scheduled study surveys completed by enrolled participants.
From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
Adherence to study procedures: completion rate of scheduled PEG assessments
Time Frame: From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
The percentage of scheduled Pain, Enjoyment, General Activity (PEG) assessments completed by enrolled participants.
From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
Adherence to study procedures: proportion of participants retained through end-of-study follow-up
Time Frame: From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
The proportion of enrolled participants who remain in the study through the end-of-study follow-up assessment.
From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
Treatment Appraisal score
Time Frame: Immediately after the Empowered Relief session, up to 2 weeks post-treatment
Treatment satisfaction assessed using the 7-item treatment appraisal questionnaire. Range 0-42, higher = greater satisfaction with the intervention
Immediately after the Empowered Relief session, up to 2 weeks post-treatment
Qualitative feedback regarding the Empowered Relief intervention
Time Frame: Immediately after the Empowered Relief session, up to 2 weeks post-treatment
Participant feedback regarding the Empowered Relief intervention, provided through optional free-text responses included in the Treatment Appraisal Questionnaire.
Immediately after the Empowered Relief session, up to 2 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute on Drug Abuse (NIDA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 5, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

March 14, 2027

Study Registration Dates

First Submitted

August 28, 2026

First Submitted That Met QC Criteria

August 28, 2026

First Posted (Actual)

September 2, 2026

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 4, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 84718
  • K24DA053564 (U.S. NIH Grant/Contract)
  • R90HD118650 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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