Storytelling for Provider Empathy & Patient Trust in Obstetric Care

May 8, 2026 updated by: Duke University

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

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 Overview

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Storytelling Intervention
Obstetric care providers view a digital storytelling video of Black women's labor pain and obstetric care experiences and complete a brief written reflection.
Providers in the intervention arm watch a digital storytelling video and complete a brief written reflection to ensure engagement.
Active Comparator: Control - Culturally Sensitive Materials
Obstetric care providers receive general written information about culturally sensitive care.
Providers in the control arm receive general written information about culturally sensitive care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2-4 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Hideyo Tsumura, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

May 8, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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