NCT07588308

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
1mo left

Started Jun 2026

Shorter than P25 for not_applicable pregnancy

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

May 8, 2026

Last Update Submit

May 8, 2026

Conditions

Keywords

EmpathyCultural CompetencyProvider-Patient RelationsTrust

Outcome Measures

Primary Outcomes (1)

  • Provider empathy survey

    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.

    Baseline and 2-4 weeks after intervention

Study Arms (2)

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.

Behavioral: Digital storytelling video + written reflection

Control - Culturally Sensitive Materials

ACTIVE COMPARATOR

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

Behavioral: General culturally sensitive care materials

Interventions

Providers in the intervention arm watch a digital storytelling video and complete a brief written reflection to ensure engagement.

Storytelling Intervention

Providers in the control arm receive general written information about culturally sensitive care.

Control - Culturally Sensitive Materials

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hideyo Tsumura

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2026

First Posted

May 14, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share