Condition category
Mental and Behavioural Disorders
Date applied
28/06/2014
Date assigned
01/08/2014
Last edited
12/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
First experiences in the operating room (OR) with real patients are always stressful and intimidating for health sciences students. We thought that a game-like simulation could improve how the students felt about, and how they performed, in the OR. An interactive videogame has been developed, with pictures and short videos, showing the students how to act when in the OR. The game also includes detailed descriptive information helpful to the students. After playing, students are given feedback on their performance. For this study, we want to see how this educational tool performs when tested with medical and nursing students with no previous OR experience.

Who can participate?
Medical and nursing students, from 3rd and 2nd year respectively at the Complutense University of Madrid with no previous experience in the OR.

What does the study involve?
Half of the students are randomly allocated to a control group (CG) and the other half to a study group (SG). Those in the SG play the game on the day before their first experience in the OR. Students in CG do not play the game. On the day after their OR experience, all students fill in a questionnaire about their experience in the OR. Students in the CG get to play the game after their first visit.

What are the possible benefits and risks of participating?
Participants gain knowledge on how to move and behave, plus some descriptive information, about the OR. Both groups of students do play the game; SG before their first visit to the operating theatre, and CG after. There are no risks of participating.

Where is the study run from?
The school of Medicine and Nursing of the Complutense University of Madrid (Spain)

When is the study starting and how long is it expected to run for?
October 2012 to May 2014

Who is funding the study?
1. Complutense University of Madrid (PIMCDs 2013-101 and 2014-161) (Madrid, Spain)
2. The Department of Surgery, School of Medicine, Complutense University of Madrid (Madrid, Spain)

Who is the main contact?
Dr Manuel Giner
manginer@med.ucm.es

Trial website

Contact information

Type

Scientific

Primary contact

Prof Manuel Giner

ORCID ID

Contact details

C/ Fernando Garrido
11
bjo. A
Madrid
28015
Spain
+34 (0) 914450637
manginer@med.ucm.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Using a videogame to facilitate students first visit to the operating room: a randomized controlled trial

Acronym

Study hypothesis

A videogame may help to overcome the difficulties experienced by students at their first visit to the operating room

Ethics approval

Ethics approval not required.

Students’ participation is entirely voluntary and performed with the informed consent of the participants. Students are orally informed about the nature of the study in which a new instructional method is investigated to the benefit of the students prior to its routine deployment. The intervention of the study (game playing and filling in a questionnaire) is not part of any examination, so that a participation or non-participation has no consequences on their grades. The ethics committee at our Medical School reviewed the project and concluded that a full formal ethics committee statement was not required, due to the educational nature of the study. Data analysis is anonymous. With the participation in the study, the students' agree on the anonymously analysis of their data. Students who do not like to participate can chose to deny participation without further consequences. Anonymous participation is document of the oral agreement of the students. This type of orally agreement employed in our study was discussed with the ethics committee which agreed on it. Due to practical reasons, a formal written consent prior to the study was not feasible.

Study design

Randomized controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Students stress at their first visit to the OR with real patients

Intervention

Students were randomly allocated to one of two groups.
1. Study group: Played an interactive videogame one day before first experience in an operating room.
2. Control group: No access to the interactive video game before first experience in an operating room.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Fear at making mistakes
2. Perceived knowledge on how to behave
3. Perceived errors committed
4. Attitude/behavior towards patients and staff

Secondary outcome measures

General opinion of the tool (videogame)

All outcome measures (primary and secondary) are measured via answers to a questionnaire in a 7-point Likert format a day after the students OR experience.

Overall trial start date

01/10/2012

Overall trial end date

30/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Medical and nursing students with no previous experience in the OR

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

130

Participant exclusion criteria

Previous experience in the operating room.

Recruitment start date

01/10/2012

Recruitment end date

30/05/2014

Locations

Countries of recruitment

Spain

Trial participating centre

C/ Fernando Garrido, 11, bjo. A
Madrid
28015
Spain

Sponsor information

Organisation

Complutense University of Madrid (Spain)

Sponsor details

c/o Manuel Giner
Department of Surgery
School of Medicine
Complutense University of Madrid
Pza/ Ramón y Cajal s/n
Madrid
28040
Spain
+34 (0) 913941217
dp085@ucm.es

Sponsor type

University/education

Website

http://www.ucm.es/cirugia

Funders

Funder type

University/education

Funder name

Complutense University of Madrid (PIMCDs 2013-101 and 2014-161) (Madrid, Spain)

Alternative name(s)

Complutense University of Madrid, UCM

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Spain

Funder name

The Department of Surgery, School of Medicine, Complutense University of Madrid (Madrid, Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

del Blanco A1, Fernández-Manjón B, Ruiz P, Giner M. Using videogames facilitates the first visit to the operating theatre. Med Educ 2013 May;47(5):519-20. doi: 10.1111/medu.12167.

Publication citations

Additional files

Editorial Notes