PregnancyNCT07588308
Storytelling for Provider Empathy & Patient Trust in Obstetric Care
A study testing Digital storytelling video + written reflection and General culturally sensitive care materials in people with Pregnancy and Labor Pain, run by Duke University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pregnancy, Labor Pain
- What is being tested?
- Digital storytelling video + written reflection and General culturally sensitive care materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Age ≥18 years.
- Able to read and converse in English.
- Receiving obstetric care from a provider who is already enrolled in the study.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Pregnancy, Labor Pain
- Being tested
- Digital storytelling video + written reflection, General culturally sensitive care materials
- Keywords
- Empathy, Cultural Competency, Provider-Patient Relations, Trust
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital storytelling video + written reflectionBehavioural
Providers in the intervention arm watch a digital storytelling video and complete a brief written reflection to ensure engagement.
General culturally sensitive care materialsBehavioural
Providers in the control arm receive general written information about culturally sensitive care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Digital storytelling video + written reflection |
| Control - Culturally Sensitive Materials | Active comparator | Obstetric care providers receive general written information about culturally sensitive care. Receives: Behavioral: General culturally sensitive care materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 2-4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Rita & Alex Hillman Foundation
- Responsible party
- Sponsor
- Investigators
- Hideyo Tsumura, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588308
- Sponsor's protocol ID
- Pro00119113
- Other IDs
- A-3942
- Status last verified
- Aug 2026
- First submitted
- 8 May 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-Developing a Nurse-Led, Community-Engaged Intervention to Improve Labor Pain Management and Build Trust in Obstetric Care
- ClinicalTrials.gov ID
- NCT07588308
- Acronym / sponsor ID
- Pro00119113
- Conditions
- Pregnancy, Labor Pain
- Keywords
- Empathy, Cultural Competency, Provider-Patient Relations, Trust
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Rita & Alex Hillman Foundation
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Storytelling Intervention | Experimental | Behavioral: Digital storytelling video + written reflectionObstetric care providers view a digital storytelling video of Black women's labor pain and obstetric care experiences and complete a brief written reflection. |
| Control - Culturally Sensitive Materials | Active comparator | Behavioral: General culturally sensitive care materialsObstetric care providers receive general written information about culturally sensitive care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Self-identified non-Hispanic Black American women.
- Age ≥18 years.
Key exclusion criteria (7 listed)
- Providers in training or with <6 months independent clinical practice.
- Providers unwilling or unable to give informed consent.
- Under 18 years of age.
- Non-English speakers (due to study survey language limitations).
- Unable or unwilling to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital storytelling video + written reflectionProviders in the intervention arm watch a digital storytelling video and complete a brief written reflection to ensure engagement. | Behavioural | Storytelling Intervention |
| General culturally sensitive care materialsProviders in the control arm receive general written information about culturally sensitive care. | Behavioural | Control - Culturally Sensitive Materials |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hideyo Tsumura principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing Digital storytelling video + written reflection and General culturally sensitive care materials in people with Pregnancy and Labor Pain, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider empathy survey (time frame: Baseline and 2-4 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.