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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Tunisia1 site
  • Mona Mlika

    Tunis, 2037

Other trials in Tunisia

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).
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 groups in NCT04076163
Study groupRoleWhat they receive
control groupNo interventiongroup of students participating to a face-to-face learning
intervention groupOthergroup 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.

  1. Critical appraisal score

    10 multiple choice questions with score /20

    Measured: 12 months

Secondary outcomes (1)
  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.

  1. First posted3 Sep 2019
  2. Study start2 Sep 2017
  3. Primary completion30 Jun 2019
  4. Study completion1 Jul 2019

Resources

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)
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

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.

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