Severe PainNCT07832240
Empowered Relief for Severe Pain After Cesarean Delivery During the Inpatient Period
A study testing Empowered Relief in people with Severe Pain and Cesarean Section Complications, run by Stanford University at 1 site in United States.
Trial summary
This pilot feasibility study will evaluate the feasibility and acceptability of delivering Empowered Relief (ER), a single-session pain management intervention, to postpartum patients experiencing severe pain following cesarean delivery during the inpatient period. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Severe 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2026to 9 Apr 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), provided the participant is clinically able to complete the study intervention and procedures.
- Currently hospitalized during the postpartum period following cesarean delivery.
Show all 10Show fewer
- Severe pain, defined as at least 2 pain scores >6/10 on the numeric rating scale (NRS), following cesarean delivery.
- 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.
- Medical or clinical instability that, in the judgment of the treating or research team, would preclude safe participation in the study procedures and/or intervention.
- Chronic pain prior to pregnancy.
- Cognitive impairment or psychological factors that would preclude comprehension of study material or full participation.
- Unable or unwilling to provide informed consent.
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
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
Guillermina Ferrea, MD, MSc, (650) 457-7704, gferrea@stanford.edu
About this study
Official title: A Single-Session Pain Management Intervention for Severe Pain After Cesarean Delivery: A Pilot Feasibility Study
This pilot feasibility study will evaluate the feasibility and acceptability of delivering Empowered Relief (ER), a single-session pain management intervention, to postpartum patients experiencing severe pain following cesarean delivery during the inpatient period. Participants will be enrolled during their inpatient postpartum hospitalization and randomized 1:1 to receive either ER in addition to standard postpartum care or standard postpartum care alone. Participants will be followed for 12 weeks postpartum.
Read the detailed description
Severe acute pain following cesarean delivery may interfere with postpartum recovery and functioning. This pilot feasibility study will evaluate the feasibility of delivering Empowered Relief (ER) during the inpatient postpartum period to patients experiencing severe pain following cesarean delivery.
Eligible participants experiencing severe pain, defined as at least 2 numeric rating scale (NRS) pain scores >6/10 during the inpatient postpartum period, will be enrolled during their inpatient postpartum hospitalization and randomized 1:1 to an intervention or control group. Participants assigned to the intervention group will receive ER in addition to standard postpartum care. ER is a single 120-minute pain relief skills class that includes pain education, cognitive behavioral skills such as relaxation, deep breathing, and cognitive reframing, and development of a personalized plan. Participants will also receive access to a relaxation resource and weekly supportive text messages. Participants assigned to the control group will receive standard postpartum care alone.
The primary objective is to assess the feasibility of delivering the ER intervention during the inpatient postpartum period. Additional feasibility and acceptability outcomes include recruitment, registration and attendance at the ER session, treatment satisfaction, treatment skills use, adherence to study procedures, and participant retention. Pain-related patient-reported outcomes will also be explored over the 12-week follow-up period. Participants will complete follow-up assessments at 3, 6, and 12 weeks postpartum, with brief PEG pain assessments collected weekly through week 12.
- Conditions
- Severe Pain, Cesarean Section Complications, Postpartum, Chronic Pain, Acute Postoperative Pain
- Being tested
- Empowered Relief
- Keywords
- Empowered Relief, Cesarean Delivery, Postpartum Pain, Acute Postoperative Pain, Pain Management, Inpatient Postpartum Care, Cognitive Behavioral Therapy
- Medical subject headings
- Pain, Chronic Pain, Pain, Postoperative, Agnosia
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 |
| Standard Postpartum Care | No intervention | Participants randomized to the control group will receive standard postpartum care alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of enrolled participants randomized to the ER intervention who complete the 120-minute ER session during the inpatient postpartum period
The proportion of participants randomized to the ER intervention arm who complete the 120-minute Empowered Relief (ER) session during the inpatient postpartum period. The proportion will be calculated as the number of participants who complete the ER session divided by the total number of participants randomized to the ER intervention arm.
Measured: Day 1 ± 5 days, during the inpatient postpartum period
Secondary outcomes (10)
Proportion of screened patients who are eligible for the study
The proportion of screened patients who meet all study eligibility criteria. The proportion will be calculated as the number of screened patients who are eligible for the study divided by the total number of patients screened.
Measured: At screening
Proportion of eligible patients that consent to study from those approached
The proportion of eligible patients approached for study participation who provide informed consent. The proportion will be calculated as the number of eligible patients who provide informed consent divided by the total number of eligible patients approached for participation.
Measured: Baseline (Day 1)
Proportion of recruited patients randomized to the ER intervention arm who register for the ER session
The proportion of participants randomized to the ER intervention arm who register for the Empowered Relief (ER) session. The proportion will be calculated as the number of participants who register for the ER session divided by the total number of participants randomized to the ER intervention arm.
Measured: Day 1 ± 5 days, during the inpatient postpartum period
Proportion of recruited patients randomized to the ER intervention arm who attend the ER session
The proportion of participants randomized to the ER intervention arm who attend the Empowered Relief (ER) session during the inpatient period. The proportion will be calculated as the number of participants who attend the ER session divided by the total number of participants randomized to the ER intervention arm.
Measured: Day 1 ± 5 days, during the inpatient postpartum period
Treatment Appraisal score (intervention arm)
Treatment satisfaction among participants in the ER intervention arm will be assessed using the 7-item Treatment Appraisal scale. Total scores range from 0 to 42, with higher scores indicating greater satisfaction with the intervention. Additional quantitative and categorical items included in the questionnaire are not included in the total score and will be summarized separately.
Measured: Immediately post-intervention or within a defined short window after ER (Day 1 ± 7)
Qualitative feedback regarding the ER intervention (intervention arm)
Qualitative feedback regarding the Empowered Relief (ER) intervention will be collected from participants in the ER intervention arm through optional free-text responses. This outcome does not generate a numerical score or scale value.
Measured: Immediately post-intervention or within a defined short window after ER (Day 1 ± 7)
Participant Treatment Skills Use Scale score (intervention arm)
Use of skills taught during the Empowered Relief (ER) intervention will be assessed among participants in the ER intervention arm using the 5-item Participant Treatment Skills Use Scale. Total scores range from 5 to 25, with higher scores indicating greater use of the skills.
Measured: Week 3; week 6; week 12
Adherence to study procedures: Completion rate of scheduled surveys
The percentage of scheduled study surveys completed by enrolled participants.
Measured: From enrollment through end-of-study (12-week follow-up)
Adherence to study procedures: Completion rate of scheduled repeated Pain, Enjoyment, General Activity (PEG) assessments
The percentage of scheduled Pain, Enjoyment, General Activity (PEG) assessments completed by enrolled participants.
Measured: Weekly from enrollment through end-of-study (12-week follow-up)
Adherence to study procedures: Participant retention 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 enrollment through end-of-study (12-week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start5 Oct 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion9 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to either Empowered Relief plus standard postpartum care or standard postpartum care alone.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Pervez Sultan, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832240
- Sponsor's protocol ID
- 88454
- Other IDs
- R90HD118650, K24DA053564
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No