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Clinical Trials/NCT07588308
NCT07588308Not yet recruitingNot Applicable

Co-Developing a Nurse-Led, Community-Engaged Intervention to Improve Labor Pain Management and Build Trust in Obstetric Care

Duke University0 sites120 target enrollmentStarted: August 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
120
Primary Endpoint
Provider empathy survey

Study Overview

Brief Summary

Aim 3 is a provider-focused pilot randomized controlled trial evaluating a digital storytelling intervention to increase obstetric care providers' empathy and to examine associations with postpartum patient trust. Providers randomized to the intervention view a video of Black women's labor pain and care experiences and complete a brief reflection; control providers receive general culturally sensitive care materials. Outcomes include change in provider empathy (primary) and patient trust among Black postpartum patients under those providers' care (secondary). Risks are minimal and mitigated via consent, voluntary participation, the option to skip questions, and secure data practices.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Provider Participants:
  • •Licensed clinician employed or credentialed at Duke Health Birthing Centers (nurse, anesthesia care provider, obstetrician, or nurse midwife).
  • •In clinical practice for at least 6 months post-orientation.
  • •Able to read and understand English.
  • •Patient Participants:
  • •Self-identified non-Hispanic Black American women.
  • •Age ≥18 years.
  • •Able to read and converse in English.
  • •Receiving obstetric care from a provider who is already enrolled in the study.

Exclusion Criteria

  • •Provider Participants:
  • •Providers in training or with <6 months independent clinical practice.
  • •Providers unwilling or unable to give informed consent.
  • •Patient Participants:
  • •Under 18 years of age.
  • •Non-English speakers (due to study survey language limitations).
  • •Unable or unwilling to provide informed consent.

Arms & Interventions

Storytelling Intervention

Experimental

Obstetric care providers view a digital storytelling video of Black women's labor pain and obstetric care experiences and complete a brief written reflection.

Intervention: Digital storytelling video + written reflection (Behavioral)

Control - Culturally Sensitive Materials

Active Comparator

Obstetric care providers receive general written information about culturally sensitive care.

Intervention: General culturally sensitive care materials (Behavioral)

Outcomes

Primary Outcomes

Provider empathy survey

Time Frame: Baseline and 2-4 weeks after intervention

An 8-question empathy survey for doctors measures perspective-taking, compassionate care, and emotional connection with patients. Each item is scored on a Likert scale of 1 (strongly disagree) to 7 (strongly agree). The total score ranges from 7 to 49, where a higher score indicates greater empathy.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Duke University
Sponsor Class
Other
Responsible Party
Sponsor

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