Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05692375 |
Other study ID # |
01 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 1, 2022 |
Est. completion date |
October 1, 2022 |
Study information
Verified date |
March 2023 |
Source |
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Gamification, listed by the European Resuscitation Council (ERC) as a learning process in its
2021 guidelines, is a new digital innovation tool that brings added value towards motivation
that seems to reuse time in a creative way. The aim of this study is to evaluate the impact
of the game "Save the shame!" on advanced life support (ALS) knowledge of nurses and
physicians in intensive care medicine settings. This is a cross-sectional study following a
mixed methodology. In its preliminary phase it follows a qualitative and exploratory
methodology, with application of the E-Delphi technique for creation and validation of the
"Save the shame! game and validation of the ALS knowledge test. The study subsequently
follows the experimental methodology. The investigators expect to confirm the hypothesis that
the game "Save the Shame!" has a positive impact on the skills training of health
professionals in intensive care medicine settings in a Portuguese hospital center.
Description:
Study Design The investigators developed an experimental approach, where randomization in
sample identification was ensured and where a control group was present, favoring a strongest
level of contribution to the evidence. This is a cross-sectional study with quantitative data
collection following a Randomized Controlled Trial (RCT) design.
In order to carry out the proposed experimental study, it was necessary to create two
essential elements in this process: the "Save the Same!" game and the ALS knowledge
assessment test, which constitutes a data collection instrument necessary to test the
research hypotheses.
Arms, Groups, and Interventions The population was defined as nurses and physicians of the
intensive care units of a Portuguese hospital center (N=275). The inclusion criteria were, to
be a nurse or a physician, to provide care in a intensive care unit of the identified
hospital center (cirurgical, cardiothoracic, coronary, medical or trauma). On the other hand,
the exclusion criteria were, be any other health professional, providing care in settings
other than intensive care settings, absence of informed consent, belonging to the invited
group of experts, participation in the instrument design pre-test.
Participants were invited via institutional email and data was collected through the access
of on-line platforms.
The experimental group was asked to use the game. Two weeks were defined as the time to use
the game. The use of the game can be seen by the coded digital record on its digital
platform. The control group neither used nor had access to the game. Afterwards both groups
performed the ALS knowledge assessment test. It is a test with 20 multiple choice questions
each scored as right (0.5 points) or wrong (0 points).
The sample was stratified in order to eliminate "professional group" variable. This was a
protocol update at made at 10th of March