An interventional study of Empowered Relief in Severe Pain, Cesarean Section Complications and Postpartum, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →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.
The criteria were revised on the registry on Oct 2, 2026. See what changed
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants randomized to the control group will receive standard postpartum care alone.
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).
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.
Time frame: Day 1 ± 5 days, during the inpatient postpartum period
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment through end-of-study (12-week follow-up)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jan 2027, 3 months later.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 3 months is below that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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