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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01798290
First Posted: February 25, 2013
Last Update Posted: April 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose

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.


Condition Intervention
Empathy Behavioral: narrative medicine: reading workshop Behavioral: critical reading

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Impact of an Educational Program 'Narrative Medicine (Workshop Reading Diaries) ' Dedicated to Medical Students. A Randomized Controlled Trial.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).

  • 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)


Estimated Enrollment: 200
Study Start Date: December 2012
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All students in the fourth year of medical

Exclusion Criteria:

  • refuse to participate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798290


Locations
France
Centre d'épidémiologie clinique, Hôtel Dieu
Paris, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01798290     History of Changes
Other Study ID Numbers: RAV002 INAMEDI
First Submitted: February 21, 2013
First Posted: February 25, 2013
Last Update Posted: April 21, 2014
Last Verified: November 2012