Condition category
Not Applicable
Date applied
28/06/2014
Date assigned
01/08/2014
Last edited
01/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The World Health Organization (WHO) surgical safety checklist (SSC) was introduced to improve the safety of surgical procedures. A worldwide study published in 2009 showed that it reduced the number of surgical complications and in hospital death by about one third. SSC can make sure that the correct standards of care are being made and improve teamwork in the operating theatre. However, this depends on how well checks are performed. Health professionals would benefit from some introductory instruction on SSC; the aim of which would be to improve their knowledge, perception and performance. For this purpose, many descriptive videos have been launched. We think an interactive videogame would add benefit to the existing materials on this topic. We have developed a game-like simulation where the operating theatre environment is reproduced using pictures and short videos. In the game, nurses, anesthesiologists and surgeons can chose their role and are shown how to follow the SSC through two simulated surgical cases. For this study, we want to see how this tool performs when tested with health professionals.

Who can participate?
Nurses, anaesthesiologists and surgeons, of any age and both genders, with experience in the operating room, from the investigators hospitals (Hospital Universitario Doce de Octubre and Hospital Universitario Clínico San Carlos) plus other hospitals of the Autonomous Community of Madrid (Hospital Universitario Puerta de Hierro, Hospital Universitario Santa Cristina and Hospital Universitario de Fuenlabrada)

What does the study involve?
All volunteer nurses, anaesthesiologists and surgeons fill in a questionnaire before and after playing the game. Questionnaires include a series of items related to SSC such as knowledge about WHO SSC, their thoughts on patient safety and their experiences from working at their own institutions.

What are the possible benefits and risks of participating?
Participants gain knowledge on SSC. All participants are given a DVD with the game plus a diploma as accreditation of their voluntary participation. There are no risks of participating.

Where is the study run from?
The five participating hospitals above.

When is the study starting and how long is it expected to run for?
July 2013 to July 2014

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

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

Validation of a videogame to increase WHO surgical safety checklist effectiveness

Acronym

Study hypothesis

Some introductory instructions on SSC would efficiently improve knowledge, perception and performance of health professionals.

Ethics approval

Ethics approval not required.

Health professionals participation is entirely voluntary and performed with the informed consent of the participants. Participants are orally informed about the nature of the study in which a new instructional method is investigated to the benefit of the health professionals prior to its routine deployment. The intervention of the study (game playing and filling in a questionnaire) is not part of any has no consequences. The ethics committee at our institution 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 participants agree on the anonymously analysis of their data. Participants who do not like to participate can chose to deny participation without further consequences. Anonymous participation is document of the oral agreement of the participants. 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

Observational

Primary study design

Observational

Secondary study design

Other

Trial setting

Other

Trial type

Screening

Patient information sheet

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

Condition

Difficulties in effectively implement the WHO-SSC

Intervention

Comparing knowledge and perception of the same professionals before and after playing the SSC videogame. The total duration of observation was around one hour.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Perceived usefulness of the SSC
2. Effort expectancy
3. Knowledge about the SSC

Secondary outcome measures

General opinion of the tool (videogame)

All outcome measures (primary and secondary) are measured via answers to two questionnaires filled in on the same day, before and after the participants videogame experience

Overall trial start date

01/07/2013

Overall trial end date

31/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Nurses, anaesthesiologists and surgeons with more than three years’ experience in operating room.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

Same personnel with shorter experience

Recruitment start date

01/07/2013

Recruitment end date

31/07/2014

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)

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)

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

Publication citations

Additional files

Editorial Notes