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.
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.
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.
- Conditions
- Empathy, Patient-centredness, Narrative Medicine
- 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.
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
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.
- First posted24 Jul 2025
- Study start2 Apr 2025
- Primary completion30 Apr 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmpathyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connolly Hospital Blanchardstown
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J Daly, MA MD PhD, Connolly Hospital Blanchardstown
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07084077
- Acronym / sponsor ID
- REC202405007
- Conditions
- Empathy, Patient-centredness, Narrative Medicine
- Keywords
- Empathy, Patient-centred communication, narrative medicine, medical education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Connolly Hospital BlanchardstownUniversity, hospital or other
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 24 Jul 2025 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Second-year medical students at RCSI Dublin
Key inclusion criteria (1 listed)
- Second-year medical students at RCSI Dublin Over 18 years of age Electing to take the student-choice module in Narrative Medicine
Key exclusion criteria (1 listed)
- English not as a first language
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 |
|---|---|---|
| Narratology education moduleAt 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. | Other | – |
Primary outcome
Change in total Consultation and Relational Empathy (CARE) Measure score as assessed by Simulated Patients
Time frame: 1 week
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.
Change in individual Consultation and Relational Empathy (CARE) Measure score items' scores as assessed by Simulated Patients
Time frame: 1 week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Derived from this study: PubMed 41331818Alhaidari 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.