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

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain; Cesarean Section Complications

• Registration Number: NCT07090018
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	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).
Participant Treatment Skills Use Scale Score	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 Outcome Measures

Name	Time	Method
Change from baseline in PROMIS Pain Interference 8a scale score	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).
Change from baseline in PROMIS Pain Intensity 3a scale score	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)
Change from baseline in Pain Catastrophizing Scale Score	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)
Change from baseline in PEG scale score (composite)	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)
Change from baseline in PEG scale score (pain interference)	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)
Change from baseline in PEG scale score (pain intensity)	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)
Response rate to individual items of the PEG scale score via SMS	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)

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States