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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
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.