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Enrolling by Invitation

NCT Number: NCT07090018

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

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.

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Key information

Conditions

Chronic Pain Cesarean Section Complications Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • <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.

Treatment and study plan

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.

Other names: 1-Session Pain Relief Skills Intervention

Primary outcomes

  1. Percentage of participants registering for Empowered Relief session

    Time frame: Baseline (up to 1 week)

  2. Percentage of participants attending Empowered Relief session

    Time frame: Treatment (up to 2 weeks)

  3. Participant Satisfaction Scale Score

    Time frame: 1 - 2 weeks Post treatment

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

  4. Participant Treatment Skills Use Scale Score

    Time frame: 4 - 6 weeks Post Treatment

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

Secondary outcomes

  1. Change from baseline in PROMIS Pain Interference 8a scale score

    Time frame: Baseline, Week 6

    Participants complete Patient Reported Outcomes Measurement Outcomes System (PROMIS) Pain Interference 8a questionnaire, an 8-item scale assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days.

    (Score range 8 - 40, higher scores represent a greater degree of pain interference).

  2. Change from baseline in PROMIS Pain Intensity 3a scale score

    Time frame: Baseline, Week 6

    Participants complete PROMIS Pain Intensity 3a questionnaire, a 3-item scale assessing average pain intensity for the past 7 days.

    (Score range 3 - 15, higher score represents a greater degree of pain intensity)

  3. Change from baseline in Pain Catastrophizing Scale Score

    Time frame: Baseline, Week 6

    Participants complete Pain Catastrophizing questionnaire, a 13-item scale assessing an individual's pain experience

    (Score range 0 - 52, higher score represents a greater degree of pain catastrophizing)

  4. Change from baseline in PEG scale score (composite)

    Time frame: From enrollment to the end of study completion at 6 weeks

    Participants complete thrice weekly Pain, Enjoyment, General Activity Scale (PEG) questionnaire, a 3-item scale assessing pain interference and intensity via SMS.

    (Score range 0 - 30, higher score represents a greater degree of pain intensity/interference)

  5. Change from baseline in PEG scale score (pain interference)

    Time frame: From enrollment to the end of study completion at 6 weeks

    Participants complete thrice weekly PEG questionnaire, to assess pain interference via SMS.

    (Score range 0 - 20, higher score represents a greater degree of interference)

  6. Change from baseline in PEG scale score (pain intensity)

    Time frame: From enrollment to the end of study completion at 6 weeks

    Participants complete thrice weekly PEG questionnaire to assess pain intensity, via SMS.

    (Score range 0 - 10, higher score represents a greater degree of pain intensity)

  7. Response rate to individual items of the PEG scale score via SMS

    Time frame: From enrollment to the end of study completion at 6 weeks

    Participant percentage responding to items of the thrice weekly PEG questionnaire, a 3-item scale assessing pain interference and intensity via SMS.

    (Score range 0 - 3; higher scores indicate higher response rate)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

A Pilot Feasibility Trial for an Intervention to Reduce Chronic Pain Following Cesarean Delivery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2025
Registry last updated
Nov 20, 2025

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.

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