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Not Yet Recruiting NCT07832240

Empowered Relief for Severe Pain After Cesarean Delivery During the Inpatient Period

Conditions: Severe Pain, Cesarean Section Complications, Postpartum, Chronic Pain, Acute Postoperative Pain

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Stanford University

Location: Lucile Packard Children's Hospital Stanford Palo Alto California

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. 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.

Eligibility Criteria

Inclusion Criteria: 1. Complete informed consent. 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), provided the participant is clinically able to complete the study intervention and procedures. 6. Currently hospitalized during the postpartum period following cesarean delivery. 7. Severe pain, defined as at least 2 pain scores \>6/10 on the numeric rating scale (NRS), following cesarean delivery. 8. English fluency, with ability to read and write. 9. Ability to adhere to and complete study procedures. 10. Access to a smart device if attending ER session via Zoom. Exclusion Criteria: 1. Age under 18 years. 2. 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. 3. Chronic pain prior to pregnancy. 4. Cognitive impairment or psychological factors that would preclude comprehension of study material or full participation. 5. Unable or unwilling to provide informed consent.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07832240). StuddyBuddy aggregates publicly available trial information.