Empowered Relief for Severe Pain After Cesarean Delivery During the Inpatient Period

NCT07832240 | Not Yet Recruiting

• 3 other identifiers: 88454R90HD118650K24DA053564
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot feasibility study will evaluate the feasibility and acceptability of delivering Empowered Relief (ER), a single-session pain management intervention, to postpartum patients experiencing severe pain following cesarean delivery during the inpatient period. Participants will be enrolled during their inpatient postpartum hospitalization and randomized 1:1 to receive either ER in addition to standard postpartum care or standard postpartum care alone. Participants will be followed for 12 weeks postpartum.

Conditions

Severe Pain; Cesarean Section Complications; Postpartum; Chronic Pain; Acute Postoperative Pain

Keywords

Empowered Relief; Cesarean Delivery; Postpartum Pain; Acute Postoperative Pain; Pain Management; Inpatient Postpartum Care; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• Proportion of enrolled participants randomized to the ER intervention who complete the 120-minute ER session during the inpatient postpartum period

  The proportion of participants randomized to the ER intervention arm who complete the 120-minute Empowered Relief (ER) session during the inpatient postpartum period. The proportion will be calculated as the number of participants who complete the ER session divided by the total number of participants randomized to the ER intervention arm.

  Day 1 ± 5 days, during the inpatient postpartum period

Secondary Outcomes (10)

• Proportion of screened patients who are eligible for the study

  At screening

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

  Baseline (Day 1)

• Proportion of recruited patients randomized to the ER intervention arm who register for the ER session

  Day 1 ± 5 days, during the inpatient postpartum period

• Proportion of recruited patients randomized to the ER intervention arm who attend the ER session

  Day 1 ± 5 days, during the inpatient postpartum period

• Treatment Appraisal score (intervention arm)

  Immediately post-intervention or within a defined short window after ER (Day 1 ± 7)

Study Arms (2)

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

Standard Postpartum Care

NO INTERVENTION

Participants randomized to the control group will receive standard postpartum care alone.

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), provided the participant is clinically able to complete the study intervention and procedures.
• Currently hospitalized during the postpartum period following cesarean delivery.
• Severe pain, defined as at least 2 pain scores \>6/10 on the numeric rating scale (NRS), following cesarean delivery.
• 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.
• Medical or clinical instability that, in the judgment of the treating or research team, would preclude safe participation in the study procedures and/or intervention.
• Chronic pain prior to pregnancy.
• Cognitive impairment or psychological factors that would preclude comprehension of study material or full participation.
• Unable or unwilling to provide informed consent.

Sponsors & Collaborators

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

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Pain; Chronic Pain; Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Guillermina Ferrea, MD, MSc

CONTACT

(650) 457-7704; gferrea@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because the behavioral intervention cannot be masked, the study is open-label. All outcomes are participant-reported.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Perioperative and Pain Medicine (Obstetrics)

Model Details: Participants will be randomized 1:1 to either Empowered Relief plus standard postpartum care or standard postpartum care alone.

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 21, 2026
• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): April 9, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)