Chronic PainNCT07799883
Reducing Chronic Pain Following Cesarean Delivery
A study testing Empowered Relief in people with Chronic Pain and Cesarean Section Complications, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Pain, Cesarean Section Complications, Postpartum
- What is being tested?
- Empowered Relief
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2026to 14 Mar 2027
- Phase
- Interventional
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
- Complete informed consent.
- Age 18 years or above.
- Postpartum woman who delivered by cesarean within the Stanford Healthcare system.
- Viable birth (singleton or multiple gestation).
- 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).
- All neonatal complications are eligible (e.g., NICU admission, extended hospital stay)
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- Attend the 6-week postpartum clinic visit.
- Any pain intensity (numeric rating scale [NRS] >0/10) and/or pain interference (PROMIS pain interference 8a score >8) at 6 weeks postpartum.
- English fluency, with ability to read and write.
- Ability to adhere to and complete study procedures.
- Access to a smart device if attending ER session via Zoom.
Who cannot join
- Age under 18 years.
- Cognitive impairment or psychological factors that would preclude comprehension of study material or full participation.
- Unable or unwilling to provide informed consent.
- Chronic pain prior to pregnancy.
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, 1 recruiting
- Recruiting
Stanford Medicine Children's Health - Specialty Services, Welch Road
Palo Alto, California, 94304
Pervez Sultan, MD, (669) 800 9929, psultan@stanford.edu
Pervez Sultan, MD
About this study
Official title: A Pilot Feasibility Study of an Intervention to Reduce Chronic Pain Following Cesarean Delivery
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.
- Conditions
- Chronic Pain, Cesarean Section Complications, Postpartum
- Being tested
- Empowered Relief
- Keywords
- Empowered Relief, Postpartum Pain, Cesarean Section, Caesarean Section, Cesarean Delivery, Pain Interference, Pain Management, Chronic Pain, Chronic Postsurgical Pain, Postpartum
- Medical subject headings
- Chronic Pain, Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered ReliefBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Empowered Relief | Experimental | 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). Receives: Behavioral: Empowered Relief |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of enrolled patients that complete the Empowered Relief session
The proportion of enrolled patients that complete the single 120-minute Empowered Relief session.
Measured: Within 2 weeks of enrollment
Secondary outcomes (10)
Proportion of screened patients who are eligible for the study
The proportion of screened patients that meet the study eligibility criteria.
Measured: During screening, at approximately 6 weeks postpartum
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.
Measured: During screening and enrollment, at approximately 6 weeks postpartum
Proportion of recruited patients who register for the Empowered Relief session
The proportion of recruited patients who register for the Empowered Relief session.
Measured: Within 1 week of enrollment
Proportion of recruited patients who attend the Empowered Relief session
The proportion of recruited patients who attend an Empowered Relief session.
Measured: Within 2 weeks of baseline
Treatment Appraisal score
Treatment satisfaction assessed using the 7-item treatment appraisal questionnaire. Range 0-42, higher = greater satisfaction with the intervention
Measured: Immediately after the Empowered Relief session, up to 2 weeks post-treatment
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.
Measured: Immediately after the Empowered Relief session, up to 2 weeks post-treatment
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.
Measured: Weekly from completion of the Empowered Relief session through 12 weeks postpartum
Adherence to Study Procedures: completion rate of scheduled surveys
The percentage of scheduled study surveys completed by enrolled participants.
Measured: From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
Adherence to study procedures: completion rate of scheduled PEG assessments
The percentage of scheduled Pain, Enjoyment, General Activity (PEG) assessments completed by enrolled participants.
Measured: From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
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.
Measured: From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start5 Oct 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion14 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Pervez Sultan, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799883
- Sponsor's protocol ID
- 84718
- Other IDs
- R90HD118650, K24DA053564
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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