Comparing the effectiveness of a pediatric airway management training program delivered through two methods of a role-playing simulation and an escape room-based serious game on knowledge and performance of students at Guilan University of Medical Sciences by using an interdisciplinary teaching approach: A randomized controlled trial
Determining and comparing the impact of an educational program on air traffic management for children using two methods: role-playing combined with simulation and serious play based on escape rooms, on the knowledge and performance of students at Guilan University of Medical Sciences with an interdisciplinary teaching approach.
Design
Randomized controlled trial with a control group, using parallel groups, unblinded, randomized, on 90 students. Sealed Envelope Ltd's online randomization service was used for randomization.
Settings and conduct
The context for conducting the research and collecting data is provided by the Shahid Beheshti School of Medicine, Nursing, and Midwifery in Rasht, and the Clinical Skills Center of the Shahid Beheshti School of Nursing and Midwifery in Rasht.
Participants/Inclusion and exclusion criteria
Entry criteria:
Willingness to participate in research. Students in the 6th and 7th years of the professional doctoral program in medicine 4th year nursing students 2nd, 3rd, and 4th year students of the continuous bachelor's program in emergency medicine
Exit criteria:
Absence in any of the training sessions. Incomplete completion of the information gathering tools in any of the screening stages, pre-test, or post-test.
Intervention groups
Intervention Group One (Role-Playing with Simulation)Intervention
Group Two (serious game based on escape room)
Control Group
Main outcome variables
Role-playing group with simulation
Serious game group based on escape room
Control group
Knowledge
Performance
Satisfaction with the teaching method
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160102025809N3
Registration date:2025-07-13, 1404/04/22
Registration timing:prospective
Last update:2025-07-13, 1404/04/22
Update count:0
Registration date
2025-07-13, 1404/04/22
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3333 8512
Email address
zahra_taheri@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-23, 1404/05/01
Expected recruitment end date
2025-08-23, 1404/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of a pediatric airway management training program delivered through two methods of a role-playing simulation and an escape room-based serious game on knowledge and performance of students at Guilan University of Medical Sciences by using an interdisciplinary teaching approach: A randomized controlled trial
Public title
Comparing the effectiveness of a pediatric airway management training program delivered through two methods of a role-playing simulation and an escape room-based serious game on knowledge and performance of students at Guilan University of Medical Sciences by using an interdisciplinary teaching approach: A randomized controlled trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in research.
the 6th and 7th years of professional medical students
Fourth-year nursing undergraduate students
Students in the 2nd, 3rd, and 4th years of continuous undergraduate medical emergency studies.
Exclusion criteria:
Experience of the company in the workshop on air way management for children
Experience in managing airways in children
Being employed in emergency and ICU
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
All selected students will be classified using stratified block randomization with block sizes of three and evenly (in a 1:1:1 ratio) divided into three groups: intervention group one (role-playing with simulation; number=30), intervention group two (serious game based on escape room; number=30), and control group (number=30). To generate a list of randomization, the online randomization service Sealed Envelope Ltd is used. The concealment of allocation is done using opaque envelopes that are sealed with a random sequence.
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 in Guilan University of Medical Sciences
Street address
Deputy of Research and Technology ,Old Building, School of Health, Shahid Siadati Avenue, Namjoo St.Guilan,Rasht,Iran
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2025-06-18, 1404/03/28
Ethics committee reference number
IR.GUMS.REC.1404.130
Health conditions studied
1
Description of health condition studied
pediatric airway management
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The score of the children's airway management knowledge in the knowledge questionnaire.
Timepoint
Immediately after the intervention
Method of measurement
The questionnaire consists of 30 items that assess students' knowledge regarding airway management in children across 5 domains (Table 4). Each item is answered based on a 4-option scale (one correct answer, two incorrect answers, and one 'I don’t know' option). A correct answer receives a score of +1, an incorrect answer receives a score of -0.5, and an 'I don’t know' answer receives a score of zero.
2
Description
Children's airway management performance score based on the checklist
Timepoint
Immediately after the intervention
Method of measurement
The performance checklist consists of 56 items that evaluate performance across 3 domains (Table 5). Each item contains two options: Yes and No. If the individual correctly performs the clinical process, the Yes option is marked; if unable to perform correctly, the No option will be completed by the evaluator.
3
Description
The level of satisfaction with the teaching method in the satisfaction questionnaire
Timepoint
Immediately after the intervention
Method of measurement
The satisfaction questionnaire comprises 8 items that measure students' satisfaction regarding the teaching method used for airway management in children. Each item is answered based on a 5-option scale: Strongly Disagree (1), Disagree (2), Neutral (3), Agree (4), and Strongly Agree (5).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention Group One (Role-Playing with Simulation): In this group, educational content is presented to students through role-playing combined with simulation, done by the researcher and supervised by faculty members, in-person during a one-hour session. For this purpose, clinical scenarios are initially developed based on the educational goals and content. A 30-minute introductory session is first held in-person, during which the course outline, educational objectives, nature of the intervention, characteristics, implementation process, and rules are thoroughly explained to the students. Then, students are divided into groups of six, consisting of two medical students, two nursing students, and two emergency medicine students, with one member chosen by group consensus to act as the representative. The groups will proceed to five different stations when the bell rings, where each station contains a scenario involving a hypothetical child in need of airway management. The scenario is read by the group representative, and then the group members negotiate and discuss to reach a common solution. At each station, groups will have a limited role-playing opportunity of 10 minutes based on the scenario. At the end of the designated time, the performance, strengths, and weaknesses of the group will be identified and addressed by the facilitator.
Category
N/A
2
Description
Intervention group: Intervention Group: Intervention Group Two (Serious Game Based on Escape Room): Students in this group will receive educational content through a serious game based on an escape room. For this purpose, an initial 30-minute face-to-face briefing session will be held, during which the course plan, educational objectives, nature of the intervention, features, implementation process, and rules will be thoroughly explained to the students. Then, students will be divided into groups of six, with each group consisting of two medical students, two nursing students, and two paramedic students. Each group enters the escape room(s) to solve the designed challenges using their teamwork skills and knowledge. In each room, there is a scenario involving a hypothetical child who requires airway management. Each scenario consists of several stages and puzzles that group members must solve collaboratively at each stage, which includes selecting the appropriate technique, choosing the necessary equipment, and determining the size of the equipment needed for the hypothetical child. After solving each puzzle at each stage, they receive a clue for the next stage until they rescue the patient. Groups have a limited time of 30 to 60 minutes to solve the puzzles and ultimately rescue the patient and find the key to exit the room. It is worth mentioning that each group has one chance in each room and it cannot be repeated. In case of confusion among learners, facilitators present in each room will provide guidance. The escape room(s) used in this research are known as Pediatric Avengers - Airway Challenge and will be designed by a team consisting of a researcher and three faculty members (a supervisory professor and consultant colleagues). The design of these rooms is based on the escapeED model proposed by Clark and colleagues and includes 6 key elements: (1) learners, (2) goals, (3) theme, (4) puzzles, (5) equipment, and (6) assessment.
Category
N/A
3
Description
Control group: In the control group, no additional intervention will take place (training in the control group will be conducted as general training: including lectures, practical stations, and the use of models).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
The medical, nursing, and midwifery schools of Shahid Beheshti University in Rasht, and the Center f
Full name of responsible person
Zahra Taheri Ezbarami
Street address
Shahid Beheshti Highway - Daneshjoo Street
City
Rasht
Province
Guilan
Postal code
41469-39814
Phone
+98 13 3255 3202
Fax
+98 13 3255 0097
Email
nursing@gums.ac.ir
Web page address
https://nmr.gums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ramiar Farzan
Street address
In front of 17 Shahrivar Hospital, Siadati St., Namjoo St
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 5821
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Guilan University of Medical Sciences Rasht Iran
Proportion provided by this source
50
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
Rasht University of Medical Sciences
Full name of responsible person
zahra taheri ezbarami
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School of Shahid Dr. Beheshti, Hamidyan Shahrak, Shahid Dr. Beheshti Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
41469-39841
Phone
+98 13 3355 5058
Fax
+98 13 3355 0097
Email
zahra_taheri@gums.ac.ir
Web page address
http://www.gums.ac.ir/nmr
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
zahra taheri ezbarami
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School of Shahid Dr. Beheshti, Hamidyan Shahrak, Shahid Dr. Beheshti Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
41469-39841
Phone
+98 13 3355 5058
Fax
+98 13 3355 0097
Email
zahra_taheri@gums.ac.ir
Web page address
http://www.gums.ac.ir/nmr
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
zahra taheri ezbarami
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School of Shahid Dr. Beheshti, Hamidyan Shahrak, Shahid Dr. Beheshti Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
41469-39841
Phone
+98 13 3355 5058
Fax
+98 13 3355 0097
Email
zahra_taheri@gums.ac.ir
Web page address
http://www.gums.ac.ir/nmr
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available