Impact of Narrative Medicine (Workshop Reading Diaries) (INAMEDI)

April 17, 2014 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Centre d'épidémiologie clinique, Hôtel Dieu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All students in the fourth year of medical

Exclusion Criteria:

  • refuse to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral: narrative medicine: reading workshop
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
Active Comparator: Behavioral: critical reading
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Jefferson Scale of Physician Empathy
Time Frame: 5 months after randomization (i.e. 1 month after the end of the intervention)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Interpersonal Reactivity Index
Time Frame: 5 months after randomization (i.e. 1 month after the end of the intervention)
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)
students' satisfaction
Time Frame: 4 months after randomization (i.e. 1 month after the end of the intervention)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 21, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 25, 2013

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 17, 2014

Last Verified

November 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • RAV002 INAMEDI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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