Impact of Narrative Medicine (Workshop Reading Diaries)

Empathy Clinical Trial

— INAMEDI  

Official title:

Impact of an Educational Program 'Narrative Medicine (Workshop Reading Diaries) ' Dedicated to Medical Students. A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798290
• Other study ID #: RAV002 INAMEDI
• Status: Completed
• Phase: N/A
• First received: February 21, 2013
• Last updated: April 17, 2014
• Start date: December 2012

Study information

• Verified date: November 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All students in the fourth year of medical

Exclusion Criteria:

• refuse to participate

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Empathy

Intervention

Behavioral:
• narrative medicine: reading workshop

• critical reading

Locations

Country	Name	City	State
France	Centre d'épidémiologie clinique, Hôtel Dieu	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	The Interpersonal Reactivity Index	self-administered questionnaire with 4 subscales (Perspective Taking, Empathic Concern, Fantasy, Personal Distress) each containing seven items (a total of 28 items). The items are scored by a Likert scale (0 = Does not describe me well to 4 = Describes me very well).	5 months after randomization (i.e. 1 month after the end of the intervention)	No
Secondary	students' satisfaction	measure on a numeric scale from 0 (without interest) to 10 (very interesting)	4 months after randomization (i.e. 1 month after the end of the intervention)	No