Empowered Relief: A One-Time Session to Help Postpartum Women Manage Ongoing Pain After Cesarean Delivery

NCT07090018 | Enrolling By Invitation

• 2 other identifiers: 804751R90HD118650
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Cesarean Section Complications

Outcome Measures

Primary Outcomes (4)

• Percentage of participants registering for Empowered Relief session

  Baseline (up to 1 week)

• Percentage of participants attending Empowered Relief session

  Treatment (up to 2 weeks)

• Participant Satisfaction Scale Score

  Participant satisfaction will be measured using a 7 item questionnaire (scale ranges from 0 - 42, higher ratings represent greater satisfaction with the treatment).

  1 - 2 weeks Post treatment

• Participant Treatment Skills Use Scale Score

  Participant treatment skills use will be measured with a 5 items questionnaire (scale ranges from 0 - 25, higher ratings represent increased time using treatment).

  4 - 6 weeks Post Treatment

Secondary Outcomes (7)

• Change from baseline in PROMIS Pain Interference 8a scale score

  Baseline, Week 6

• Change from baseline in PROMIS Pain Intensity 3a scale score

  Baseline, Week 6

• Change from baseline in Pain Catastrophizing Scale Score

  Baseline, Week 6

• Change from baseline in PEG scale score (composite)

  From enrollment to the end of study completion at 6 weeks

• Change from baseline in PEG scale score (pain interference)

  From enrollment to the end of study completion at 6 weeks

Study Arms (2)

1-Session pain relief skills session (Empowered Relief)

EXPERIMENTAL

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

Behavioral: Empowered Relief

Control arm: Postpartum Standard of Care

NO INTERVENTION

Participants will follow their current standard of care.

Interventions

Empowered Relief BEHAVIORAL

The participants will attend a pain relief skills intervention (Empowered Relief). The two-hour session is delivered by a certified instructor and includes pain neuroscience education, 3 core pain management skills, experiential exercises, completion of a personalized plan for empowered relief. Participants download a binaural relaxation audio file for daily use.

Also known as: 1-Session Pain Relief Skills Intervention

1-Session pain relief skills session (Empowered Relief)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females 18 years of age or older
• Any postpartum woman who has had a cesarean delivery in the Stanford Healthcare system with a viable birth
• has moderate/severe pain, scoring ≥ 4/10 on the numerical/visual analog scale that continues at 6 weeks postpartum
• English fluency
• Ability to adhere to and complete study protocols
• Access to smart device for zoom / video meetings

You may not qualify if:

• \<18yrs
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Ciechanowicz S, Joy RR, Kasmirski J, Blake L, Carvalho B, Sultan P. Incidence, Severity, and Interference of Chronic Postsurgical Pain After Cesarean Delivery: A Systematic Review and Meta-analysis. J Clin Anesth. 2025 Jun;104:111832. doi: 10.1016/j.jclinane.2025.111832. Epub 2025 Apr 24.

  PMID: 40279839 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pervez Sultan, MBChB, FRCA, MD(Res)

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 29, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Wish whom? Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For what types of analysis? For individual participant data meta-analysis By what mechanism will data be made available? Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be provided).

Locations

US (1)