Healthy StudentsNCT04076163
About the Efficacy of a Serious Game in Critical Appraisal
A study testing serious game in people with Healthy Students, run by mona mlika at 1 site in Tunisia.
Trial summary
Background: serious games have been reported as valuable method of learning since a decade. Even if their evident efficiency hasn't been always reported, their influence on the learners' motivation has become consensual. Read more about this study
- Who is it for?
- Ages 20 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Students
- What is being tested?
- serious game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Sep 2017to 1 Jul 2019
- Phase
- Interventional
- 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 20 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Third-year medical students
- Students in the department of Pathology
Who cannot join
- Other medical students
- Non consenting students
Trial locations and contacts
1 site in 1 country.
About this study
Official title: About the Efficacy of a Serious Game in Critical Appraisal Learning
Background: serious games have been reported as valuable method of learning since a decade. Even if their evident efficiency hasn't been always reported, their influence on the learners' motivation has become consensual. The authors aim to assess the efficacy of using serious games to teach critical appraisal practice to medical students in comparison to face-to-face learning methods.
Material and methods: the authors will perform a cluster randomised controlled trial including third-year medical students. Both groups will receive the same initial learning about elementary principals of evidence-based-medicine. Then, the control group will perform a critical appraisal of a case report and a recommendation article guided by a checklist and the intervention group performed a critical appraisal of the same manuscripts using a home-made serious game. Both groups will be invited to fulfil a multiple-choice-question test and a satisfaction likert-scale questionnaire.
Read the detailed description
- Population: since 2013, 25 students in the third year of medical training are received in the Department of Pathology every year. The students were divided into 7 groups of 4 to 5 students with an interval period of 2 to 3 weeks between the different groups. The students were assigned randomly by the faculty of medicine of Tunis. The training period lasts three weeks according to the university's recommendations. All the students that were assigned by the faculty and who gave their consent to participate to this study were included. The students that were performing their training period in other Departments were excluded.
- Type of study: this is a cluster randomised controlled trial. This kind of randomization will be used because of the university board's assignment. It seems more comfortable to the tutor to use the same method of learning to every group.
- Intervention: this interventional and longitudinal study will be performed during a year-period. The students' groups will be randomly assigned to two groups by using computerised random number allocation and will be given the same pre and post test to answer. The test consists in a 7 general multiple-choice-questions in addition to 5 multi-choice questions related to a manuscript. Besides, The trainees will fulfil a Likert-type-scale satisfaction questionnaire to report their self-assessed competences and their motivation. Every suggestion will be coted between 1 to 4.
- Learning activities: training objectives are listed in the students' university portfolio. These objectives were performed by the faculty staff and validated by the pedagogical committee. The objectives were divided into items related to technical skills, the resolution of problems, ethical attitude and the critical appraisal of a scientific publication.
A diary about the daily activities of the students is available in the e-portfolio of the students. It contains their repartition in the Department and the different learning activities. Different methods of learning are displayed in the Department of Pathology including traditional methods which consisted in lectures dealing with the pathologies mentioned in the training board, integrative and participative methods consisting in case-based and problem-based learning.
The five steps of the evidence-based-practice (EBP) are planned during the third week. During the 4 initial days, the tutor will initiate the students to the elementary principles of evidence-based-medicine practice. Learning methods are mainly lecture-based. During the fifth day, groups that are randomized to the control group will participate to a workshop, which consisted in a collective critical appraisal session. The students will perform a critical appraisal of a case report and guidelines entitled: "Spontaneous regression of locally advanced non small cell lung cancer" and "Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up" (7,8). The choice of case report and recommendations was motivated by the fact that the students have never been practicing critical appraisal. The students will be given a checklist of the Tunisia medical journal (http://www.latunisiemedicale.com/) in order to facilitate this practice.
The intervention group will practice a critical appraisal of the same manuscript using the serious game developed by the tutor.
- Serious game: the authors developed a simulation-based serious game with design elements consisting in avatars, scores and explanations. This game was performed using itystudio software. The different scenes took place into a medical consultation. The students (players) have to choose the doctor's avatar. A realistic scenario was performed in order to include the approach of critical appraisal into a realistic health problem. The scenario performed was a 50-year-old-patient visiting his family doctor to explore an episode of haemoptysis. This episode was explored and the medical doctor had to announce the diagnosis of lung cancer to his patient. In order to explain the disease to the patient and to prepare him to the future investigations and to the treatment modalities, the doctor had to deal with a case report about a spontaneous regression of a lung cancer then recommendations of the ESMO. With every article downloaded by the students, a series of questions were asked and scored. When the students gave the good answers, the game continued and if they failed the game was over. Every student had the opportunity to repeat the game. Three competences were evaluated: announcing bad news, the critical appraisal of a case report and the critical appraisal of recommendations. Every competency was scored and the player received the final scores represented into 3 axes in the end of the game. The scenario established to perform the game is represented in figure 2. Some illustrations of the game are represented in figure 3. The game was also made available through the Department site link: https://sites.google.com/a/fmt.utm.tn/externes-services-d-anatomie-pathologique-prof-mezni/. The major characteristics of the game are represented in table 2.
- Statistics: statistical tests used to compare the scores between both groups consisted in student test with alpha levels set at 0.05. The authors used SPSS software (version 20.0).
- Conditions
- Healthy Students
- Being tested
- serious game
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serious gameOther
a serious game was performed by the investigators in order to enhance the critical appraisal practice of students
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | group of students participating to a face-to-face learning |
| intervention group | Other | group of students using serious game Receives: Other: serious game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical appraisal score
10 multiple choice questions with score /20
Measured: 12 months
Secondary outcomes (1)
Satisfaction questionnaire
12 questions scaled from 1 to 4
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start2 Sep 2017
- Primary completion30 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy StudentsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- mona mlika
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, mona mlika, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076163
- Sponsor's protocol ID
- 1234
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- About the Efficacy of a Serious Game in Critical Appraisal Learning
- ClinicalTrials.gov ID
- NCT04076163
- Acronym / sponsor ID
- 1234
- Conditions
- Healthy Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- mona mlikaUniversity, hospital or other
- Study start
- 2 Sep 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 3 Sep 2019 (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.
Background: serious games have been reported as valuable method of learning since a decade. Even if their evident efficiency hasn't been always reported, their influence on the learners' motivation has become consensual. The authors aim to assess the efficacy of using serious games to teach critical appraisal practice to medical students in comparison to face-to-face learning methods.
Material and methods: the authors will perform a cluster randomised controlled trial including third-year medical students. Both groups will receive the same initial learning about elementary principals of evidence-based-medicine. Then, the control group will perform a critical appraisal of a case report and a recommendation article guided by a checklist and the intervention group performed a critical appraisal of the same manuscripts using a home-made serious game. Both groups will be invited to fulfil a multiple-choice-question test and a satisfaction likert-scale questionnaire.
Detailed description
- Population: since 2013, 25 students in the third year of medical training are received in the Department of Pathology every year. The students were divided into 7 groups of 4 to 5 students with an interval period of 2 to 3 weeks between the different groups. The students were assigned randomly by the faculty of medicine of Tunis. The training period lasts three weeks according to the university's recommendations. All the students that were assigned by the faculty and who gave their consent to participate to this study were included. The students that were performing their training period in other Departments were excluded.
- Type of study: this is a cluster randomised controlled trial. This kind of randomization will be used because of the university board's assignment. It seems more comfortable to the tutor to use the same method of learning to every group.
- Intervention: this interventional and longitudinal study will be performed during a year-period. The students' groups will be randomly assigned to two groups by using computerised random number allocation and will be given the same pre and post test to answer. The test consists in a 7 general multiple-choice-questions in addition to 5 multi-choice questions related to a manuscript. Besides, The trainees will fulfil a Likert-type-scale satisfaction questionnaire to report their self-assessed competences and their motivation. Every suggestion will be coted between 1 to 4.
- Learning activities: training objectives are listed in the students' university portfolio. These objectives were performed by the faculty staff and validated by the pedagogical committee. The objectives were divided into items related to technical skills, the resolution of problems, ethical attitude and the critical appraisal of a scientific publication.
A diary about the daily activities of the students is available in the e-portfolio of the students. It contains their repartition in the Department and the different learning activities. Different methods of learning are displayed in the Department of Pathology including traditional methods which consisted in lectures dealing with the pathologies mentioned in the training board, integrative and participative methods consisting in case-based and problem-based learning.
The five steps of the evidence-based-practice (EBP) are planned during the third week. During the 4 initial days, the tutor will initiate the students to the elementary principles of evidence-based-medicine practice. Learning methods are mainly lecture-based. During the fifth day, groups that are randomized to the control group will participate to a workshop, which consisted in a collective critical appraisal session. The students will perform a critical appraisal of a case report and guidelines entitled: "Spontaneous regression of locally advanced non small cell lung cancer" and "Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up" (7,8). The choice of case report and recommendations was motivated by the fact that the students have never been practicing critical appraisal. The students will be given a checklist of the Tunisia medical journal (http://www.latunisiemedicale.com/) in order to facilitate this practice.
The intervention group will practice a critical appraisal of the same manuscript using the serious game developed by the tutor.
- Serious game: the authors developed a simulation-based serious game with design elements consisting in avatars, scores and explanations. This game was performed using itystudio software. The different scenes took place into a medical consultation. The students (players) have to choose the doctor's avatar. A realistic scenario was performed in order to include the approach of critical appraisal into a realistic health problem. The scenario performed was a 50-year-old-patient visiting his family doctor to explore an episode of haemoptysis. This episode was explored and the medical doctor had to announce the diagnosis of lung cancer to his patient. In order to explain the disease to the patient and to prepare him to the future investigations and to the treatment modalities, the doctor had to deal with a case report about a spontaneous regression of a lung cancer then recommendations of the ESMO. With every article downloaded by the students, a series of questions were asked and scored. When the students gave the good answers, the game continued and if they failed the game was over. Every student had the opportunity to repeat the game. Three competences were evaluated: announcing bad news, the critical appraisal of a case report and the critical appraisal of recommendations. Every competency was scored and the player received the final scores represented into 3 axes in the end of the game. The scenario established to perform the game is represented in figure 2. Some illustrations of the game are represented in figure 3. The game was also made available through the Department site link: https://sites.google.com/a/fmt.utm.tn/externes-services-d-anatomie-pathologique-prof-mezni/. The major characteristics of the game are represented in table 2.
- Statistics: statistical tests used to compare the scores between both groups consisted in student test with alpha levels set at 0.05. The authors used SPSS software (version 20.0).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –group of students participating to a face-to-face learning |
| intervention group | Other | Other: serious gamegroup of students using serious game |
Who may qualify
- Ages
- 20 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Third-year medical students
- Students in the department of Pathology
Key exclusion criteria (2 listed)
- Other medical students
- Non consenting students
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 gamea serious game was performed by the investigators in order to enhance the critical appraisal practice of students | Other | intervention group |
Primary outcome
Critical appraisal score
Time frame: 12 months
10 multiple choice questions with score /20
1 secondary outcome
Satisfaction questionnaire
Time frame: 12 months
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 3 Sep 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serious game in people with Healthy Students, run by mona mlika at 1 site in Tunisia.
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 3 Sep 2019. 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 Tunisia. 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?
Critical appraisal score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2019.