ClinicalTrials.gg
RecruitingNCT07799883Updated Oct 28, 2026

Reducing Chronic Pain Following Cesarean Delivery

An interventional study of Empowered Relief in Chronic Pain, Cesarean Section Complications and Postpartum, sponsored by Stanford University. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Updated Oct 28, 2026Now RecruitingStart date moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

This pilot study will evaluate the feasibility and acceptability of delivering Empowered Relief (ER), a single-session pain relief skills class, to postpartum women with ongoing pain and/or pain interference following cesarean delivery. Participants will receive ER in addition to standard postpartum care and will be followed through 12 weeks postpartum.

02

Conditions studied

  • Chronic Pain
  • Cesarean Section Complications
  • Postpartum

Keywords

  • Empowered Relief
  • Postpartum Pain
  • Cesarean Section
  • Caesarean Section
  • Cesarean Delivery
  • Pain Interference
  • Pain Management
  • Chronic Pain
  • Chronic Postsurgical Pain
  • Postpartum
03

In context

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Complete .
  2. Age 18 years or above.
  3. Postpartum woman who delivered by cesarean within the Stanford Healthcare system.
  4. Viable birth (singleton or multiple gestation).
  5. All maternal demographics and complications are eligible: parity, medical conditions (e.g., pre-eclampsia, gestational diabetes), and post-surgical complications (e.g., hysterectomy, ICU admission, extended hospital stay).
  6. All neonatal complications are eligible (e.g., NICU admission, extended hospital stay)
  7. Attend the 6-week postpartum clinic visit.
  8. Any pain intensity (numeric rating scale [NRS] >0/10) and/or pain interference (PROMIS pain interference 8a score >8) at 6 weeks postpartum.
  9. English fluency, with ability to read and write.
  10. Ability to adhere to and complete study procedures.
  11. Access to a smart device if attending ER session via Zoom.

Exclusion criteria

Exclusion Criteria:

  1. Age under 18 years.
  2. Cognitive impairment or psychological factors that would preclude comprehension of study material or full participation.
  3. Unable or unwilling to provide .
  4. Chronic pain prior to pregnancy.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Empowered Relief

    Participants will receive a single 120-minute Empowered Relief session in addition to standard postpartum care. The session includes pain education and cognitive-behavioral pain management skills, including relaxation, deep breathing, reframing, and development of a personalized plan. Participants will also receive access to a smartphone relaxation resource (Calm Tool app, or a relaxation audio file if the app cannot be downloaded).

    Behavioral: Empowered Relief

Interventions

  • BehavioralEmpowered Relief

    A single 120-minute pain relief skills class delivered by trained, certified instructors via Zoom or in person. The session includes pain education, cognitive behavioral skills including relaxation, deep breathing, and reframing, and completion of a personalized plan. Following the session, participants receive access to the Calm Tool smartphone relaxation app (or a binaural relaxation audio file if the app cannot be downloaded).

06

What researchers measure

Primary outcomes

  1. Proportion of enrolled patients that complete the Empowered Relief session

    The proportion of enrolled patients that complete the single 120-minute Empowered Relief session.

    Time frame: Within 2 weeks of enrollment

Secondary outcomes

  1. Proportion of screened patients who are eligible for the study

    The proportion of screened patients that meet the study eligibility criteria.

    Time frame: During screening, at approximately 6 weeks postpartum

  2. Proportion of eligible patients that consent to study from those approached

    The proportion of eligible patients who provide informed consent and enroll in the study.

    Time frame: During screening and enrollment, at approximately 6 weeks postpartum

  3. Proportion of recruited patients who register for the Empowered Relief session

    The proportion of recruited patients who register for the Empowered Relief session.

    Time frame: Within 1 week of enrollment

  4. Proportion of recruited patients who attend the Empowered Relief session

    The proportion of recruited patients who attend an Empowered Relief session.

    Time frame: Within 2 weeks of baseline

  5. Treatment Appraisal score

    Treatment satisfaction assessed using the 7-item treatment appraisal questionnaire. Range 0-42, higher = greater satisfaction with the intervention

    Time frame: Immediately after the Empowered Relief session, up to 2 weeks post-treatment

  6. Qualitative feedback regarding the Empowered Relief intervention

    Participant feedback regarding the Empowered Relief intervention, provided through optional free-text responses included in the Treatment Appraisal Questionnaire.

    Time frame: Immediately after the Empowered Relief session, up to 2 weeks post-treatment

  7. Participant Treatment Skills Use Scale score

    Use of skills learned during the Empowered Relief intervention assessed using the 5-item Participant Treatment Skills Use Scale. Total scores range from 0 to 25, with higher scores indicating greater use of treatment skills.

    Time frame: Weekly from completion of the Empowered Relief session through 12 weeks postpartum

  8. Adherence to Study Procedures: completion rate of scheduled surveys

    The percentage of scheduled study surveys completed by enrolled participants.

    Time frame: From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum

  9. Adherence to study procedures: completion rate of scheduled PEG assessments

    The percentage of scheduled Pain, Enjoyment, General Activity (PEG) assessments completed by enrolled participants.

    Time frame: From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum

  10. Adherence to study procedures: proportion of participants retained through end-of-study follow-up

    The proportion of enrolled participants who remain in the study through the end-of-study follow-up assessment.

    Time frame: From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum

07

Study locations

1 of 1 sites recruiting
  • Stanford Medicine Children's Health - Specialty Services, Welch Road
    Palo Alto, California 94304, United States
    Recruiting
    • Pervez Sultan, MD · Contactpsultan@stanford.edu · (669) 800 9929
    • Pervez Sultan, MD · Principal investigator
08

References and documents

Publications

  • Jethwa A, Nguyen N, Michel G, Simons LE, Rabbitts J, Panelli DM, Darnall BD, Sultan P. Use of a single pain coping skills session (Empowered Relief) for outpatient postpartum pain following cesarean delivery: a pilot feasibility study. Int J Obstet Anesth. 2026 Aug;67:105190. doi: 10.1016/j.ijoa.2026.105190. Epub 2026 Apr 28. PubMed 42349309 ↗

Individual participant data

Plan to share: No

09

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 19, 2026
Sites
Stanford Medicine Children's Health - Specialty Services, Welch Road is now Recruiting
Oct 19, 2026
Start date
Oct 5, 2026→Oct 26, 2026 (actual)
Oct 28, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Stanford Medicine Children's Health - Specialty Services, Welch Road · Palo Alto, United StatesContact added p•••@stanford.edu · •••9929
Oct 19, 2026
Show all 2 updates
  1. Oct 28, 2026
    Start date Oct 5, 2026→Oct 26, 2026 (now actual)
  2. Oct 19, 2026
    Not yet recruiting→Recruiting
    Stanford Medicine Children's Health - Specialty Services, Welch Road is now Recruiting
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Stanford Medicine Children's Health - Specialty Services, Welch Road · Palo Alto, United StatesContact added p•••@stanford.edu · •••9929
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07799883
Responsible party
Pervez Sultan (Professor of Anesthesiology, Perioperative and Pain Medicine (Obstetrics), Stanford University) — Principal investigator
First posted
Sep 2, 2026
Start date
Oct 26, 2026
Primary completion
Jan 31, 2027 (estimated)
Completion
Mar 14, 2027 (estimated)
Last update
Oct 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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