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

NCT ID: NCT07090018

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-25

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Chronic Pain Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1-Session pain relief skills session (Empowered Relief)

Participants will attend an Empowered Relief session at the beginning of the study period.

Empowered Relief is a 2-hour one session pain relief skills intervention that is delivered to patients by a certified instructor using a standardized treatment manual and slide deck. Content includes completion of a pain survey, pain neuroscience education, information on pain and stress responses, experiential exercises, information on three core pain management skills, completion of a personalized plan for empowered relief, and receipt of a binaural app for daily use.

Standard of care will be maintained for all participants, and supplemented with Empowered Relief. Pain management is not a factor for inclusion/exclusion criteria and patients will continue their pain management as prescribed and directed by their provider

Group Type EXPERIMENTAL

Empowered Relief

Intervention Type 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.

Control arm: Postpartum Standard of Care

Participants will follow their current standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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1-Session Pain Relief Skills Intervention

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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PSultan

Professor of Anesthesiology, Perioperative and Pain Medicine (Obstetrics)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pervez Sultan, MBChB, FRCA, MD(Res)

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 40279839 (View on PubMed)

Other Identifiers

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1R90HD118650

Identifier Type: NIH

Identifier Source: secondary_id

View Link

80475

Identifier Type: -

Identifier Source: org_study_id

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