Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07799883

Reducing 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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Chronic Pain Agnosia Cesarean Section Complications Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postpartum Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Palo Alto, California, 94304, United States

Location contact

Pervez Sultan, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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).

Primary outcomes

  1. Proportion of enrolled patients that complete the Empowered Relief session

    Time frame: From baseline to the Empowered Relief session, up to 2 weeks

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Participant Treatment Satisfaction Scale score

    Time frame: Immediately after the Empowered Relief session

    Treatment satisfaction assessed using the 7-item Participant Treatment Satisfaction Scale. Total scores range from 0 to 42, with higher scores indicating greater satisfaction with the intervention.

  6. Qualitative feedback regarding the peripartum Empowered Relief intervention

    Time frame: Immediately after the Empowered Relief session

    Participant feedback regarding the Empowered Relief intervention collected through free-text responses.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.