Empowered Relief: A One-Time Session to Help Postpartum Women Manage Ongoing Pain After Cesarean Delivery

Stanford University

Status: Invitation-only

Conditions: Cesarean Section Complications; Chronic Pain

Treatments: Behavioral: Empowered Relief

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07090018

1R90HD118650 (U.S. NIH Grant/Contract)

80475

Details and patient eligibility

About

The purpose of this study is to study the effect of a pain relief skills session (Empowered Relief) on chronic pain incidence at 12 weeks post cesarean delivery.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females 18 years of age or older
• Any postpartum woman who has had a cesarean delivery in the Stanford Healthcare system with a viable birth
• has moderate/severe pain, scoring ≥ 4/10 on the numerical/visual analog scale that continues at 6 weeks postpartum
• English fluency
• Ability to adhere to and complete study protocols
• Access to smart device for zoom / video meetings

Exclusion criteria

• <18yrs
• Chronic pain prior to pregnancy
• Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1-Session pain relief skills session (Empowered Relief)

Experimental group

Description:

Participants will attend an Empowered Relief session at the beginning of the study period. Empowered Relief is a 2-hour one session pain relief skills intervention that is delivered to patients by a certified instructor using a standardized treatment manual and slide deck. Content includes completion of a pain survey, pain neuroscience education, information on pain and stress responses, experiential exercises, information on three core pain management skills, completion of a personalized plan for empowered relief, and receipt of a binaural app for daily use. Standard of care will be maintained for all participants, and supplemented with Empowered Relief. Pain management is not a factor for inclusion/exclusion criteria and patients will continue their pain management as prescribed and directed by their provider

Treatment:

Behavioral: Empowered Relief

Control arm: Postpartum Standard of Care

No Intervention group

Description:

Participants will follow their current standard of care.