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Enrolling by invitation NCT07090018

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

No phase Interventional Chronic Pain Cesarean Section Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Empowered Relief.
Who it may be relevant to
Registry conditions: Chronic Pain, Cesarean Section Complications. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot Feasibility Trial for an Intervention to Reduce Chronic Pain Following Cesarean Delivery

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.

Interventions

  • Behavioral Empowered Relief
    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.

Primary outcome measures

  • 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 [Time frame: 1 - 2 weeks Post treatment]
  • Participant Treatment Skills Use Scale Score [Time frame: 4 - 6 weeks Post Treatment]
Secondary outcome measures (7)
  • Change from baseline in PROMIS Pain Interference 8a scale score [Time frame: Baseline, Week 6]
  • Change from baseline in PROMIS Pain Intensity 3a scale score [Time frame: Baseline, Week 6]
  • Change from baseline in Pain Catastrophizing Scale Score [Time frame: Baseline, Week 6]
  • Change from baseline in PEG scale score (composite) [Time frame: From enrollment to the end of study completion at 6 weeks]
  • Change from baseline in PEG scale score (pain interference) [Time frame: From enrollment to the end of study completion at 6 weeks]
  • Change from baseline in PEG scale score (pain intensity) [Time frame: From enrollment to the end of study completion at 6 weeks]
  • Response rate to individual items of the PEG scale score via SMS [Time frame: From enrollment to the end of study completion at 6 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University — Palo Alto

Publications

  • Ciechanowicz S, Joy RR, Kasmirski J, Blake L, Carvalho B, Sultan P. Incidence, Severity, and Interference of Chronic Postsurgical Pain After Cesarean Delivery: A Systematic Review and Meta-analysis. J Clin Anesth. 2025 Jun;104:111832. doi: 10.1016/j.jclinane.2025.111832. Epub 2025 Apr 24. PMID 40279839

Identifiers

NCT: NCT07090018 · 80475 · 1R90HD118650

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗