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

N/AEnrolling By InvitationNCT07090018

Stanford University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Pain Cesarean Section Complications

Interventions

Empowered ReliefBEHAVIORAL

The participants will attend a pain relief skills intervention (Empowered Relief). The two-hour session is delivered by a certified instructor and includes pain neuroscience education, 3 core pain management skills, experiential exercises, completion of a personalized plan for empowered relief. Participants download a binaural relaxation audio file for daily use.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Stanford University

Palo Alto, California, United States

Outcomes

Primary Outcomes

Percentage of participants registering for Empowered Relief session

Time frame: Baseline (up to 1 week)

Percentage of participants attending Empowered Relief session

Time frame: Treatment (up to 2 weeks)

Participant Satisfaction Scale Score

Participant satisfaction will be measured using a 7 item questionnaire (scale ranges from 0 - 42, higher ratings represent greater satisfaction with the treatment).

Time frame: 1 - 2 weeks Post treatment

Participant Treatment Skills Use Scale Score

Participant treatment skills use will be measured with a 5 items questionnaire (scale ranges from 0 - 25, higher ratings represent increased time using treatment).

Time frame: 4 - 6 weeks Post Treatment

Secondary Outcomes

Change from baseline in PROMIS Pain Interference 8a scale score

Participants complete Patient Reported Outcomes Measurement Outcomes System (PROMIS) Pain Interference 8a questionnaire, an 8-item scale assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. (Score range 8 - 40, higher scores represent a greater degree of pain interference).

Time frame: Baseline, Week 6

Change from baseline in PROMIS Pain Intensity 3a scale score

Participants complete PROMIS Pain Intensity 3a questionnaire, a 3-item scale assessing average pain intensity for the past 7 days. (Score range 3 - 15, higher score represents a greater degree of pain intensity)

Time frame: Baseline, Week 6

Change from baseline in Pain Catastrophizing Scale Score

Data from ClinicalTrials.gov

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