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

NCT07192718 | Enrolling By Invitation

• 2 other identifiers: 804895R90HD118650
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications; Postpartum Care

Outcome Measures

Primary Outcomes (6)

• 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

  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 Outcomes (7)

• Change from baseline in PROMIS Pain Interference 8a scale score

  Baseline, Week 3, Week 8, Week 14

• Change from baseline in PROMIS Pain Intensity 3a scale score

  Baseline, Week 3, Week 8, Week 14

• Change from baseline in Pain Catastrophizing Scale Score

  Baseline, Week 3, Week 8, Week 14

• Change from baseline in Pain Interference Scale Score via SMS

  Baseline through end of study (up to 14 weeks)

• Response rate to Pain Interference scale score via SMS

  Baseline through end of study (up to 14 weeks)

Study Arms (2)

1-Session pain relief skills session (Empowered Relief) and Education

EXPERIMENTAL

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; Other: Education

Standard of Care

NO INTERVENTION

Participants will follow their current standard of care.

Interventions

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.

Also known as: 1-Session Pain Relief Skills Intervention

1-Session pain relief skills session (Empowered Relief) and Education

Education OTHER

Educational content: Participants view videos online focusing on specific areas of postpartum recovery (Sleep, Mental Health, Physical Therapy, Obstetric care).

1-Session pain relief skills session (Empowered Relief) and Education

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Stanford University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (2)

• 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.

  PMID: 40279839 BACKGROUND

• 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.

  PMID: 40244582 BACKGROUND

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Pervez Sultan

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Perioperative and Pain Medicine (Obstetrics)

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• 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).

Locations

US (1)