NCT01798290

Brief Summary

Objective: The aim of this study is to assess the impact of an educational program of Narrative Medicine "workshop reading diaries" dedicated to medical students on their empathy. Design: Randomized Controlled Trial in 2 arms. Participants: Medical students (4th years) of the University Paris Descartes. Methods: participants will be randomized in 2 groups. The allocation of participants will be done by a computerized randomization list, the sequence will be created by an independent statistician. Participants will be blinded of the study hypothesis. Allocation concealment will be provided because only the statistician will have access to the randomization list. A program of Narrative Medicine with lesson in small group of "workshop reading patients' diaries " vs "workshop reading literature". Outcome: The primary endpoint will be a first measure of the empathy of the medical students. The secondary endpoints will be a second measure of the empathy of the medical student; satisfaction of the student relative to the educational program . Potential interests: We believe that the workshop "reading patients' diaries" can develop the thinking of the student with respect to his behavior with the patient, and so the relation between student and patient. Sample size expected: 200 participants.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Last Updated

April 21, 2014

Status Verified

November 1, 2012

Enrollment Period

6 months

First QC Date

February 21, 2013

Last Update Submit

April 17, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Jefferson Scale of Physician Empathy

    self-administered questionnaire consisting of 20 items scored by a Likert-type scale (strongly agree = 7, strongly disagree = 1): 10 items are rated positively, others 10 items are rated negatively. The total score ranges from 20 to 140.

    5 months after randomization (i.e. 1 month after the end of the intervention)

Secondary Outcomes (2)

  • The Interpersonal Reactivity Index

    5 months after randomization (i.e. 1 month after the end of the intervention)

  • students' satisfaction

    4 months after randomization (i.e. 1 month after the end of the intervention)

Study Arms (2)

Behavioral: narrative medicine: reading workshop

EXPERIMENTAL

Students allocated to the active comparator arm will follow 5 sessions in Class-led instruction of reading patients' diaries or nurses'diaries. They will be divided into eight subgroups of 12 students. The first and fifth sessions will be presential, and 2nd 3rd and 4th sessions will be homework to do on internet.

Behavioral: narrative medicine: reading workshop

Behavioral: critical reading

ACTIVE COMPARATOR

Students allocated to the active comparator arm will follow 5 sessions in Class-led instruction of reading literature. They will be divided into eight subgroups of 12 students. The first and fifth sessions will be presential, and 2nd 3rd and 4th sessions will be homework to do on internet.

Behavioral: critical reading

Interventions

Behavioral: narrative medicine: reading workshop
Behavioral: critical reading

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All students in the fourth year of medical

You may not qualify if:

  • refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'épidémiologie clinique, Hôtel Dieu

Paris, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 25, 2013

Study Start

December 1, 2012

Primary Completion

June 1, 2013

Last Updated

April 21, 2014

Record last verified: 2012-11

Locations