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EmpathyNCT07084077

Investigating the Effects of a Short Narratology Education Module on Empathy and Patient-centred Communication in Early-stage Medical Students.

An observational study of Empathy and Patient-centredness, run by Connolly Hospital Blanchardstown at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Effective communication is a fundamental skill in clinical medicine; however, traditional approaches often fail to equip learners with an ability to authentically and empathically engage with the complexities of real patients' experiences. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Empathy, Patient-centredness, Narrative Medicine
What is being tested?
Narratology education module
How many people
22 participants
Where
1 siteIreland
Study dates
2 Apr 2025to 10 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Second-year medical students at RCSI Dublin

Who may be able to join

  • Second-year medical students at RCSI Dublin Over 18 years of age Electing to take the student-choice module in Narrative Medicine

Who cannot join

  • English not as a first language

Trial locations and contacts

1 site in 1 country.

Ireland1 site
  • RCSI School of Medicine

    Dublin, Dublin, D02 YN77

Other trials in Ireland

About this study

Official title: Investigating the Effects of a Short Narratology Education Module on Empathy and Patient-centred Communication in Early-stage Medical Students: an Empirical Mixed-methods Pilot Study.

Effective communication is a fundamental skill in clinical medicine; however, traditional approaches often fail to equip learners with an ability to authentically and empathically engage with the complexities of real patients' experiences. Narratology education has been proposed as a pedagogical framework for augmenting empathy and patient-centred communication in medical students.

In April 2025, we undertook a mixed-methods pilot study to evaluate the impact of a one-week narratology education module on second-year undergraduate medical students at the Royal College of Surgeons in Ireland (RCSI), Dublin. The module involved close reading, group viewings, facilitated small-group workshops, and whole-group discussions in response to narrative works by Irish writers and storytellers, followed by written personal reflections. At the outset and conclusion of the module, each student undertook a clinical history with a simulated patient (SP) portraying early-stage dementia. SPs assessed each student's empathy and communication using the CARE Measure.

Read the detailed description

Effective communication is a fundamental skill in clinical medicine; however, traditional approaches often fail to equip learners with an ability to authentically and empathically engage with the complexities of real patients' experiences. Narratology education has been proposed as a pedagogical framework for augmenting empathy and patient-centred communication in medical students.

In April 2025, we undertook a mixed-methods pilot study to evaluate the impact of a one-week narratology education module on second-year undergraduate medical students at the Royal College of Surgeons in Ireland (RCSI), Dublin. The module involved close reading, group viewings, facilitated small-group workshops, and whole-group discussions in response to narrative works by Irish writers and storytellers, followed by written personal reflections. At the outset and conclusion of the module, each student undertook a clinical history with a simulated patient (SP) portraying early-stage dementia. SPs assessed each student's empathy and communication using the CARE Measure.

Included students undertook two encounters with a simulated patient (SP): one immediately before and one immediately after the one-week narratology education module. In each encounter, students carried out a 7-minute history-taking exercise with an SP portraying cognitive decline/early-stage dementia. Immediately following each encounter, each SP completed the CARE Measure (11) - a validated tool to assess empathy and communication skills in healthcare workers. In the CARE Measure, ten items are rated on a five-point scale from 1 (poor) to 5 (excellent), with the total score being the sum of those ten items; in the event of missing or not applicable (N/A) ratings, the mean rating of available items was calculated and then multiplied by ten to estimate the total score. The CARE Measure items cover key aspects of empathy and clinical communication, including "Really listening," "Letting you tell your story," "Showing care and compassion," and "Being interested in you as a whole person." Ten SPs, with experience in medical education, were employed to perform a scripted-narrative of cognitive decline/early-stage dementia that had been iteratively developed by the investigating team and agreed by consensus prior to the start of the module. Each SP received the approved scripted-narrative one-week prior to the start of the module; in addition, they undertook a one-hour group pre-briefing session immediately prior to each simulation to ensure consistency of performance. Both pre-briefing sessions were facilitated by the investigating team including the narratology-expert.

At the end of the module, students submitted a reflective essay, i.e., 500-words using the Gibbs cycle as a framework, articulating how they had interrogated the narrative works of Irish writers and storytellers during the week and how narratology education had affected their appreciation for point-of-view and perspective in personal stories, their evolving narrative competence, and their empathy, communication, and performance in healthcare encounters.

Statistical analyses were undertaken using Stata/SE 17.0 (StataCorp [2021] Stata: Release 17. College Station, TX: StataCorp LLC.), GraphPad Prism version 10 (GraphPad Software, Boston, Massachusetts USA), and NVivo 15 (Lumivero [2023] NVivo (Version 15). Lumivero.).

Central tendencies for ordinal data are presented as median (interquartile range [IQR]). Pre- and post-intervention CARE Measure total scores and their individual item ratings were compared using the Wilcoxon matched-pairs signed-rank test, with a two-tailed P < 0.05 considered statistically significant.

Reflection essays were uploaded to NVivo 15 for thematic analysis.

Being tested
Narratology education module
Keywords
Empathy, Patient-centred communication, narrative medicine, medical education
Medical subject headings
Narrative Medicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Narratology education moduleOther

    At RCSI Dublin, mentioned by James Joyce in Dubliners, a one-week student-choice module Narrative Medicine: lessons from Irish writers and storytellers was offered to those in the second of our five-year undergraduate medical degree program, i.e., students were 18-months into the curriculum, had limited communication skills training, and no real-world clinical exposure. The module used close reading, group viewing, small-group workshops, and whole-group discussions to foster narrative competence. A medically-trained narratology-expert facilitated students' interrogation of classic and award-winning non-healthcare themed works by Irish writers and storytellers, i.e., directors and/or producers.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in total Consultation and Relational Empathy (CARE) Measure score as assessed by Simulated Patients

    In the CARE Measure, ten items are rated on a five-point scale from 1 (poor) to 5 (excellent), with the total score being the sum of those ten items (maximum score 50, minimum score zero); in the event of missing or not applicable (N/A) ratings, the mean rating of available items was calculated and then multiplied by ten to estimate the total score.

    Measured: 1 week

  2. Change in individual Consultation and Relational Empathy (CARE) Measure score items' scores as assessed by Simulated Patients

    In the CARE Measure, ten items are rated on a five-point scale from 1 (poor) to 5 (excellent), with the total score being the sum of those ten items (maximum score 50, minimum score zero); in the event of missing or not applicable (N/A) ratings, the mean rating of available items was calculated and then multiplied by ten to estimate the total score.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2025
  2. Study start2 Apr 2025
  3. Primary completion30 Apr 2025
  4. Study completion10 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07084077
Sponsor's protocol ID
REC202405007
Status last verified
Aug 2025
First submitted
17 Jul 2025
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alhaidari B, Mulhall C, Condron C, Shpigelman J, Jain D, Daly MJ. Investigating the effects of a short narratology module on empathy and patient-centred communication in early-stage medical students: an empirical mixed-methods pilot study. BMC Med Educ. 2025 Dec 2;26(1):15. doi: 10.1186/s12909-025-08264-7.

    PubMed 41331818

Questions about this trial

What is this clinical trial studying?

An observational study of Empathy and Patient-centredness, run by Connolly Hospital Blanchardstown at 1 site in Ireland.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in total Consultation and Relational Empathy (CARE) Measure score as assessed by Simulated Patients (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07084077, which also lists 1 linked publication.

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 7 Aug 2025.

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