Using Empowered Relief and Education To Help Postpartum Women Recover After Cesarean Delivery

Not Applicable

Not yet recruiting

• Conditions: Cesarean Section Complications; Postpartum Care

• Registration Number: NCT07192718
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this study is to study the effect of a pain relief skills session (Empowered Relief) and educational content on global postpartum recovery at 12 weeks post cesarean delivery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-25
• Last Update Posted: 2025-09-25
• 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 woman scheduled for a cesarean delivery in the Stanford Healthcare system with a viable birth
• 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 2 weeks)
Percentage of participants attending Empowered Relief session	Treatment (up to 2 weeks)
Empowered Relief: 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).
Empowered Relief: Participant Treatment Skills Use Scale Score	Week 3, Week 8, Week 14	Participant treatment skills use will be measured with a 5 items questionnaire (scale ranges from 0 - 25, higher ratings represent increased time using treatment).
Percentage of participants watching educational content	Treatment (up to 2 weeks), Week 3
Educational content: Participant Satisfaction Scale Score	1 - 2 weeks Post treatment, Week 3, Week 8, Week 14	Participant satisfaction will be measured using a 7 item questionnaire with three scored items: overall usefulness (0-6), the usefulness rating of each module (0-6), and frequency of use (0-3). The composite score ranges from 0-15, with higher scores indicating greater satisfaction and use. Additional checklist and free-text items capture engagement but are not included in the score.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in PROMIS Pain Interference 8a scale score	Baseline, Week 3, Week 8, Week 14	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 3, Week 8, Week 14	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 3, Week 8, Week 14	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 Pain Interference Scale Score via SMS	Baseline through end of study (up to 14 weeks)	Participants complete twice weekly questionnaire to assess pain interference via SMS. (Score range 0 - 10, higher score represents a greater degree of interference)
Response rate to Pain Interference scale score via SMS	Baseline through end of study (up to 14 weeks)	This outcome determines the percentage of participants responding to the twice weekly pain interference scale score via SMS text.
Change from baseline in PROMIS Sleep Disturbance 8a scale score	Baseline, Week 3, Week 8, Week 14	Participants complete Patient Reported Outcomes Measurement Outcomes System (PROMIS) Sleep Disturbance 8a questionnaire, an 8-item scale assessing self-reported perceptions of sleep quality, sleep depth, restoration, perceived difficulties and concerns with getting to sleep/staying asleep, as well as perceptions of the adequacy and satisfaction with sleep over the past 7 days. (Score range 8 - 40, higher scores represent a greater degree of sleep disturbance).
Change from baseline in STanford Obstetric Recovery checKlist (STORK) scale score	Baseline, Week 2, Week 3, Week 8, Week 14	Participants complete the STORK questionnaire, a 47-item scale assessing postpartum recovery over the past 7 days. (Score range 0 - 188, higher score represents a greater degree of recovery)

Trial Locations

Locations (1)

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