EducationNCT03092440
Validity Assessment of the "LabForGames Warning" Serious Game
An observational study of Education, run by Université Paris-Sud at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Education
- What is being tested?
- serious game
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to 30 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Voluntary divided into three groups : * "Nursing students" group * "New nurses" group: Nurses with < 2 years experience * "Expert nurses" group: Intensive nurses (with ≥ 4 years experience post graduate)
Who may be able to join
- Nursing students or nurses with < 2 years experience or intensive nurses (with ≥ 4 years experience post graduate)
- and having agreed to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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).
- Conditions
- Education
- Being tested
- serious game
- Keywords
- Medical Education, simulation, serious game, validity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serious gameOther
During three hours, each learner will play with the three different cases of the "LabForGames Warning" serious game.
| Study group | Role | What they receive |
|---|---|---|
| "Nursing students" group | nursing students Receives: Other: serious game | |
| "New nurses" group | Nurses with < 2 years experience Receives: Other: serious game | |
| "Expert nurses" group | Intensive nurses (with ≥ 4 years experience post graduate) Receives: Other: serious game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 min
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).
Measured: 60 min
Secondary outcomes (3)
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)
Measured: 30 min
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).
Measured: 5 min
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).
Measured: 25 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start1 Mar 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Paris-Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonia Blanie, Université Paris-Sud
- Investigators
- Antonia Blanié, M.D, Principal investigator, Université Paris Sud, 91 400 Orsay, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092440
- Sponsor's protocol ID
- LabForSIMS-002
- Status last verified
- Nov 2018
- First submitted
- 14 Mar 2017
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blanie A, Amorim MA, Meffert A, Perrot C, Dondelli L, Benhamou D. Assessing validity evidence for a serious game dedicated to patient clinical deterioration and communication. Adv Simul (Lond). 2020 May 27;5:4. doi: 10.1186/s41077-020-00123-3. eCollection 2020.
PubMed 32514382
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity Assessment of the "LabForGames Warning" Serious Game
- ClinicalTrials.gov ID
- NCT03092440
- Acronym / sponsor ID
- LabForSIMS-002
- Conditions
- Education
- Keywords
- Medical Education, simulation, serious game, validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Université Paris-SudUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "Nursing students" group | – | Other: serious gamenursing students |
| "New nurses" group | – | Other: serious gameNurses with < 2 years experience |
| "Expert nurses" group | – | Other: serious gameIntensive nurses (with ≥ 4 years experience post graduate) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Voluntary divided into three groups : * "Nursing students" group * "New nurses" group: Nurses with < 2 years experience * "Expert nurses" group: Intensive nurses (with ≥ 4 years experience post graduate)
Key inclusion criteria (2 listed)
- Nursing students or nurses with < 2 years experience or intensive nurses (with ≥ 4 years experience post graduate)
- and having agreed to participate
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serious gameDuring three hours, each learner will play with the three different cases of the "LabForGames Warning" serious game. | Other | "Expert nurses" group, "New nurses" group, "Nursing students" group |
Primary outcome
The score (/100) of each case of the serious game
Time frame: 60 min
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.
the duration (min) of each case of the serious game
Time frame: 60 min
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).
3 secondary outcomes
The content and parameters of the serious game
Time frame: 30 min
Learners' satisfaction
Time frame: 5 min
The resemblance between the virtual game and the real life clinical practice
Time frame: 25 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Derived from this study: PubMed 32514382Blanie A, Amorim MA, Meffert A, Perrot C, Dondelli L, Benhamou D. Assessing validity evidence for a serious game dedicated to patient clinical deterioration and communication. Adv Simul (Lond). 2020 May 27;5:4. doi: 10.1186/s41077-020-00123-3. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia Blanié, M.D principal investigator
Université Paris Sud, 91 400 Orsay, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Education, run by Université Paris-Sud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score (/100) of each case of the serious game (time frame: 60 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03092440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.