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

March 6, 2026 updated by: Pervez Sultan, Stanford University

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of participants attending Empowered Relief session
Time Frame: Treatment (up to 2 weeks)
Treatment (up to 2 weeks)
Percentage of participants registering for Empowered Relief session
Time Frame: Baseline (up to 2 weeks)
Baseline (up to 2 weeks)
Empowered Relief: Participant Satisfaction Scale Score
Time Frame: 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).
1 - 2 weeks Post treatment
Empowered Relief: Participant Treatment Skills Use Scale Score
Time Frame: 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).
Week 3, Week 8, Week 14
Percentage of participants watching educational content
Time Frame: Treatment (up to 2 weeks), Week 3
Treatment (up to 2 weeks), Week 3
Educational content: Participant Satisfaction Scale Score
Time Frame: 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.
1 - 2 weeks Post treatment, Week 3, Week 8, Week 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in PROMIS Pain Interference 8a scale score
Time Frame: 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).
Baseline, Week 3, Week 8, Week 14
Change from baseline in PROMIS Pain Intensity 3a scale score
Time Frame: 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)
Baseline, Week 3, Week 8, Week 14
Change from baseline in Pain Catastrophizing Scale Score
Time Frame: 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)
Baseline, Week 3, Week 8, Week 14
Change from baseline in Pain Interference Scale Score via SMS
Time Frame: 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)
Baseline through end of study (up to 14 weeks)
Response rate to Pain Interference scale score via SMS
Time Frame: 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.
Baseline through end of study (up to 14 weeks)
Change from baseline in PROMIS Sleep Disturbance 8a scale score
Time Frame: 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).
Baseline, Week 3, Week 8, Week 14
Change from baseline in STanford Obstetric Recovery checKlist (STORK) scale score
Time Frame: 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)
Baseline, Week 2, Week 3, Week 8, Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pervez Sultan, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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