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

A Pilot Feasibility Trial for a Comprehensive Multimodal Intervention to Assess Global Recovery Following Cesarean Delivery

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cesarean Section Complications; Postpartum Care
• Intervention / Treatment: Behavioral: Empowered Relief; Other: Education

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1-Session pain relief skills session (Empowered Relief) and Education; Participants will view educational content online on postpartum care and attend a 2 hour Empowered Relief session at the beginning of the study period. Standard of care will be maintained for all participants, and supplemented with Educational content and Empowered Relief.	Behavioral: Empowered Relief; 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; Other: Education; Educational content: Participants view videos online focusing on specific areas of postpartum recovery (Sleep, Mental Health, Physical Therapy, Obstetric care).
No Intervention: Standard of Care; Participants will follow their current standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants attending Empowered Relief session		Treatment (up to 2 weeks)
Percentage of participants registering for Empowered Relief session		Baseline (up to 2 weeks)
Empowered Relief: Participant Satisfaction Scale Score	Participant satisfaction will be measured using a 7 item questionnaire (scale ranges from 0 - 42, higher ratings represent greater satisfaction with the treatment).	1 - 2 weeks Post treatment
Empowered Relief: Participant Treatment Skills Use Scale Score	Participant treatment skills use will be measured with a 5 items questionnaire (scale ranges from 0 - 25, higher ratings represent increased time using treatment).	Week 3, Week 8, Week 14
Percentage of participants watching educational content		Treatment (up to 2 weeks), Week 3
Educational content: Participant Satisfaction Scale Score	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.	1 - 2 weeks Post treatment, Week 3, Week 8, Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in PROMIS Pain Interference 8a scale score	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).	Baseline, Week 3, Week 8, Week 14
Change from baseline in PROMIS Pain Intensity 3a scale score	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)	Baseline, Week 3, Week 8, Week 14
Change from baseline in Pain Catastrophizing Scale Score	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)	Baseline, Week 3, Week 8, Week 14
Change from baseline in Pain Interference Scale Score via SMS	Participants complete twice weekly questionnaire to assess pain interference via SMS. (Score range 0 - 10, higher score represents a greater degree of interference)	Baseline through end of study (up to 14 weeks)
Response rate to Pain Interference scale score via SMS	This outcome determines the percentage of participants responding to the twice weekly pain interference scale score via SMS text.	Baseline through end of study (up to 14 weeks)
Change from baseline in PROMIS Sleep Disturbance 8a scale score	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).	Baseline, Week 3, Week 8, Week 14
Change from baseline in STanford Obstetric Recovery checKlist (STORK) scale score	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)	Baseline, Week 2, Week 3, Week 8, Week 14

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Pervez Sultan, Stanford University

Publications and helpful links

General Publications

• Ciechanowicz S, Joy RR, Kasmirski J, Blake L, Carvalho B, Sultan P. Incidence, Severity, and Interference of Chronic Postsurgical Pain After Cesarean Delivery: A Systematic Review and Meta-analysis. J Clin Anesth. 2025 Jun;104:111832. doi: 10.1016/j.jclinane.2025.111832. Epub 2025 Apr 24.
• Sultan P, Pandal P, Murthy A, Guo N, Farber MK, Toledo P, Higgins N, Fiore JF Jr, Domingue BW, Khorasani E, Jensen SE, Lyell DJ, Carvalho B; Stanford Obstetric Recovery Checklist (STORK) Investigators. Development and Validation of the Stanford Obstetric Recovery Checklist (STORK): A Delphi Consensus and Multicenter Clinical Validation Study. JAMA Netw Open. 2025 Apr 1;8(4):e255713. doi: 10.1001/jamanetworkopen.2025.5713.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 17, 2025
• First Submitted That Met QC Criteria: September 17, 2025
• First Posted (Actual): September 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: 80489; 5R90HD118650 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Wish whom? Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For what types of analysis? For individual participant data meta-analysis By what mechanism will data be made available? Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be provided).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No