Protocol summary

Study aim
Designing and determining the effect of using a serious educational game on the clinical diagnosis and performance of medical students in dealing with burn victims
Design
A randomized controlled clinical trial with parallel groups, phase 2, will be conducted on 70 medical students. Stata software will be used for randomization.
Settings and conduct
This study will be conducted on 70 medical students, in the Burns Department of Imam Reza Hospital, Mashhad, that will be randomly assigned to intervention and control groups. Control group students will receive the educational content on "clinical diagnosis and performance in dealing with burn victims" using routine teaching methods. The intervention group will also use a serious game designed in addition to routine teaching methods for one week. To assess the performance of students in both groups, the Mini-CEX test will be administered before the start of the intervention and 7 days after the end of the training period.
Participants/Inclusion and exclusion criteria
medical student at MUMS, having a smartphone with internet access, the first clinical recognition and performance experience in dealing with burned patients, passing the pre-internship exam, informed consent to participate in the study.
Intervention groups
In the intervention group, students will learn the principles of clinical diagnosis and performance in dealing with burn victims through a web-based serious game, in addition to the usual training methods. The control group, will only receive the necessary trainings on clinical diagnosis and performance of various types of burns and how to provide drug instructions through the usual methods, such as attending classes with professors in the burn ward and morning rounds.
Main outcome variables
Clinical diagnosis and performance of medical students when facing burn patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171123037599N3
Registration date: 2023-08-10, 1402/05/19
Registration timing: prospective

Last update: 2023-08-10, 1402/05/19
Update count: 0
Registration date
2023-08-10, 1402/05/19
Registrant information
Name
Razieh Froutan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 4241
Email address
froutanr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-11, 1402/05/20
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and Evaluating the effect of an Educational Serious Game on the Clinical Performance and Diagnosis of Medical Students in the Management of Burn Patients
Public title
Designing and Evaluating the effect of an Educational Serious Game on the Clinical Performance and Diagnosis of Medical Students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Medical student at Mashhad University of Medical Sciences Access to the internet by a smartphone First experience in the diagnosis and clinical management of burn patients Successful completion of pre-internship exam obtaining informed consent for participation in a study
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate individuals randomly into intervention and control groups, the website www.randomization.com can be used. This website provides a random sequence of 70 letters A and B in a 1:1 ratio (35 letters A and 35 letters B). In the next step, 35 cards labeled A and 35 cards labeled B are prepared and numbered from 1 to 70 according to the sequence provided on the website. When each participant enters, the corresponding packet is opened based on the number assigned to them, and the volunteer group is determined accordingly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ethics committee of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.042

Health conditions studied

1

Description of health condition studied
the clinical diagnosis and performance of medical students in dealing with burn patients.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mini Clinical Evaluation Exercise (Mini-CEX) score.
Timepoint
Before starting the intervention and 7 days after completing the training course.
Method of measurement
Mini Clinical Evaluation Exercise (Mini-CEX)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: In addition to receiving routine educational content, medical students will receive contents related to diagnosis and correct clinical practice when dealing with burn patients through a serious web-based game for one week. The game system will be based on the burn curriculum and will have several stages. After registering and entering the game, students will be given explanations about the diagnosis of burn types and how to evaluate and perform clinical procedures, then some questions will be asked about the mentioned section. They should choose the appropriate option according to the time allotted to answer the questions. In case of choosing the wrong answer, in addition to displaying a message about the wrong choice, without referring to the correct option, the professors will give explanations in the form of voice and video about why his answer is wrong. But if the correct option is selected, in addition to encouraging the student, a brief explanation is given to emphasize the correct option and confirm the student's learning, and a point is also considered for him. If 60% of the questions of each stage are answered correctly, the student can enter the next stage. Also, students can compare their scores with other students and see their rank in the group at any time.
Category
N/A

2

Description
Control group: The students of this group will participate in burn clinic and department and case morning with professors for one week and will learn diagnosis and clinical practice when dealing with burn patients in this way (routine method).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Razieh Froutan
Street address
Ebne- Sina Street, School of Nursing and Midwifery, Mashhad,Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 915 119 1124
Email
froutanr@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology
Street address
Ghoreishi building,Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913119
Phone
+98 51 3841 2081
Email
froutanr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Froutan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ebne-Sina Street Mashhad, IranMashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
froutanr@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Hasan Tavousi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Mashhad, Ibn Sina Street, Imam Reza Hospital.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 9841 2081
Email
TavoosiH@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Hasan Tavousi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Mashhad, Ibn Sina Street, Imam Reza Hospital.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3841 2081
Email
TavoosiH@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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