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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07832240
Status
Not Yet Recruiting

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Conditions

  • Acute Postoperative Pain
  • Cesarean Section Complications
  • Chronic Pain
  • Postpartum
  • Severe Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empowered Relief — BEHAVIORAL
    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 Details

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.

Key Dates

First listed
Sep 21, 2026
Start date
Oct 5, 2026
Status verified
Sep 2026
Primary completion
Jan 15, 2027
Completion
Apr 9, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).
  • No Intervention: Standard Postpartum Care
    Participants randomized to the control group will receive standard postpartum care alone.

Primary Outcome Measure

Proportion of enrolled participants randomized to the ER intervention who complete the 120-minute ER session during the inpatient postpartum period [ Time Frame: Day 1 ± 5 days, during the inpatient postpartum period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lucile Packard Children's Hospital StanfordPalo AltoCalifornia94304
Guillermina Ferrea, MD, MSc
[email protected]
(650) 457-7704

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By research site
Lucile Packard Children's Hospital Stanford· Palo Alto, CA

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