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Cesarean Section ComplicationsNCT07192718

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

A study testing Empowered Relief and Education in people with Cesarean Section Complications and Postpartum Care, run by Stanford University at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Empowered Relief and Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
2 Dec 2025to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • <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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Stanford University

    Palo Alto, California, 94304

Other trials in United States

About this study

Official title: 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.

Read the detailed description

study design was amended

Being tested
Empowered Relief, Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empowered ReliefBehavioural

    Also called 1-Session Pain Relief Skills Intervention

    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.

  • EducationOther

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

Study groups in NCT07192718
Study groupRoleWhat they receive
1-Session pain relief skills session (Empowered Relief) and EducationExperimentalParticipants 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.
Receives: Behavioral: Empowered Relief; Other: Education
Standard of CareNo interventionParticipants will follow their current standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants registering for Empowered Relief session

    Measured: Baseline (up to 4 weeks)

  2. Percentage of participants attending Empowered Relief session

    Measured: Treatment (up to 4 weeks)

  3. 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).

    Measured: Week 1- 4 Post treatment

  4. 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).

    Measured: Week 5, Week 10, Week 16

  5. Percentage of participants watching educational content

    Measured: Treatment (up to 4 weeks)

  6. Percentage of participants watching educational content post delivery

    Measured: Week 5 - 16

  7. 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.

    Measured: Week 1- 4 Post treatment, Week 5, Week 10, Week 16

Secondary outcomes (7)

  1. 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).

    Measured: Baseline, Week 5, Week 10, Week 16

  2. 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)

    Measured: Baseline, Week 5, Week 10, Week 16

  3. 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)

    Measured: Baseline, Week 5, Week 10, Week 16

  4. 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).

    Measured: Baseline, Week 5, Week 10, Week 16

  5. 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)

    Measured: Baseline through end of study (up to 16 weeks)

  6. 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.

    Measured: Baseline through end of study (up to 16 weeks)

  7. 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)

    Measured: Week 5, Week 10, Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2025
  2. Study start2 Dec 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07192718
Sponsor's protocol ID
80489
Other IDs
5R90HD118650
Status last verified
Nov 2025
First submitted
17 Sep 2025
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

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.

    PubMed 40279839

  • 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.

    PubMed 40244582

Questions about this trial

What is this clinical trial studying?

A study testing Empowered Relief and Education in people with Cesarean Section Complications and Postpartum Care, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants registering for Empowered Relief session (time frame: Baseline (up to 4 weeks)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07192718, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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