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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03092440
Other study ID # LabForSIMS-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2017
Est. completion date September 30, 2017

Study information

Verified date November 2018
Source Université Paris-Sud
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The use of simulation in medical education has been associated with positive results in the acquisition of knowledge, skills, behaviors and patient outcome. Serious games are useful educational tools since they allow both theory and practice training for an important number of learners, simultaneously. However, few studies have evaluated the validity and effectiveness of serious games.

Our simulation unit (LabForSIMS- Faculté de Médecine Paris-Sud, France) has developed a serious game named "LabForGames Warning" for nursing students with the following learning objectives: to recognize and to address the degradation of a patient's clinical condition and to work on the issue of inter-professional communication. The aim of the present study is to determine content and construct validities of the "LabForGames Warning" serious game before its use as a healthcare professional training tool.


Description:

This observational single-center open study will be conducted in the simulation center of the Paris-Sud medical school (LabForSIMS). After written consent, the study population (nurses and nursing students) will attend a three hours simulation session with the "LabForGames Warning" serious game and will be divided into three groups :

- Nursing students

- New Nurses: Nurses with < 2 years experience

- Expert Nurses: Intensive nurses, with ≥ 4 years experience post graduate.

During three hours, each learner will play with the three different cases of the "LabForGames Warning" serious game then an auto-evaluation will be recorded.

The primary outcome measure was the evaluation of the construct validity:

The score (/100) and the duration (min) of each case of the serious game will be reported in order to assess whether the difference of the measures is related to the difference of skills between the three groups. An auto-evaluation of clinical reasoning will also be recorded.

The secondary outcome measure was the evaluation of content and face validities. For content validity, the content and parameters will be tested by the nurses ≥ 4 years experienced (Ten-point Likert scale) For face validity, the students' satisfaction and the resemblance between the virtual game and the real life clinical practice will be evaluated in the three groups (Ten-point Likert scale).


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date September 30, 2017
Est. primary completion date September 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Nursing students or nurses with < 2 years experience or intensive nurses (with = 4 years experience post graduate)

- and having agreed to participate

Exclusion Criteria:

- Subjects incapable of giving consent: incapacitated (subjects under guardianship), minors (< 18 years)

- Refusal to participate in to the study Refusal to sign in the confidentiality clause

Study Design


Related Conditions & MeSH terms


Intervention

Other:
serious game
During three hours, each learner will play with the three different cases of the "LabForGames Warning" serious game.

Locations

Country Name City State
France Faculté de médecine Paris Sud Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor Collaborator
Université Paris-Sud

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The score (/100) of each case of the serious game The score (/100) of each case of the serious game will be reported in order to assess whether the difference of the measures is related to the difference of skills between the three groups (Evaluation of the construct validity). An auto-evaluation of clinical reasoning will also be recorded. 60 min
Primary the duration (min) of each case of the serious game The duration (min) of each case of the serious game will be reported in order to assess whether the difference of the measures is related to the difference of skills between the three groups (Evaluation of the construct validity). 60 min
Secondary The content and parameters of the serious game For content validity, the content and parameters of the serious game will be tested by the nurses = 4 years experienced (Ten-point Likert scale) 30 min
Secondary Learners' satisfaction For face validity, the learners' satisfaction and the resemblance between the virtual game and the real life clinical practice will be evaluated in the three groups (Ten-point Likert scale). 5 min
Secondary The resemblance between the virtual game and the real life clinical practice For content validity, the resemblance between the virtual game and the real life clinical practice will be evaluated in the three groups (Ten-point Likert scale). 25 min
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