Protocol summary

Study aim
Determine the impact of using a computer-based simulator on students' functional error in performing laryngoscopy skills.
Design
The experimental study, with two groups of control and intervention, is a blinded one on 26 second semester undergraduate students of Anesthesiology, University of Tehran, in the 96-97 academic year.
Settings and conduct
Students in Tehran University of Medical Sciences are randomly assigned to two groups of control and intervention. A control group without any intervention in the skill lab performed by an experienced anesthetist and through a checklist (based on the Objective Structured Assessment of Technical Skills) are evaluated. The simulation content intervention group plus video pictures with descriptions, and animations to emphasize important points, and students will be able to view the content as desired before entering Skill Lab. It is then evaluated in an skill lab by an experienced anesthetist and through a checklist (compiled on the OSATS checklist). The evaluator will not be aware of belonging to any group. The scores obtained from both groups are compared to determine the effectiveness of using multimedia content and the number of errors in the patient's preparation is also observed and compared to the two groups.
Participants/Inclusion and exclusion criteria
All second semester students of Anesthesiology who have completed compulsory and routine course on airway management training through lectures and participating in Skill lab at Tehran University of Medical Sciences and have informed consent to participate in the project.
Intervention groups
A control group that is evaluated without any intervention, and an intervention group giving simulated content plus video images with descriptions, and animations to emphasize important points. Students can view this content as often as they like before entering the Skill Lab.
Main outcome variables
Functional error

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090127001599N26
Registration date: 2018-02-14, 1396/11/25
Registration timing: prospective

Last update: 2018-02-14, 1396/11/25
Update count: 0
Registration date
2018-02-14, 1396/11/25
Registrant information
Name
Mitra Zolfaghari
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
zolfaghm@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-05-05, 1397/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of computer-based simulator on basic clinical psychomotor skill performanceand patients prepration for intubation and laryngoscopy by undergraduate anesthesist students in Tehran University of Medical Sciences
Public title
The effect of computer-based simulator on basic clinical psychomotor skill performanceand patients prepration for intubation and laryngoscopy by undergraduate anesthesist students in Tehran University of Medical Sciences
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Participants are second semester undergraduate students who have completed standard and routine airway management training through lectures and a two-hour Skill Lab session at Tehran University of Medical Sciences.
Exclusion criteria:
lack of consent to participate in the project
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
The names of the students who are willing to participate in the project are tabulated and divided using random numbers into two groups of intervention and control.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the control group without intervention and the intervention group after intervention received a separate assessment. In both stages, the evaluator is unaware of whether or not they have received the intervention.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Vice-Chancellor for Research, Tehran University of Medical Sciences
Street address
Qods St, Keshavarz Blvd.Tehran,
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-12-10, 1396/09/19
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4180

Health conditions studied

1

Description of health condition studied
Functional error
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Functional error
Timepoint
A week after receiving the simulator
Method of measurement
Using the OSATS (Objective Structured Assessment of Technical Skills)

Secondary outcomes

empty

Intervention groups

1

Description
The control group is evaluated without an intervention in the skill lab by an experienced anesthetist and through a checklist (developed according to the OSATS checklist). This assessment involves preparing the patient, choosing the correct equipment for
Category
Other

2

Description
The intervention group is provided with simulated content, and students can view the content as often as they wish before entering the Skill Lab. (Submission of this content to the intervention group after the evaluation of the control group is performed
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran university of medical science
Full name of responsible person
Saba Abbasi
Street address
Qods St, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
Cs_abbasi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mitra Zolfaghari
Street address
Qods St, Keshavarz Blov, Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
Cs_abbasi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Saba Abbasi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Hassan Aabad Sq, Emam khomini St, Sina hospital
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 63120
Email
Cs_abbasi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mitra Zolfaghari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Naderi st. Keshavarz Blv. Virtual School. Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6692 7171
Fax
+98 21 6693 3600
Email
zolfaghm@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mitra Zolfaghari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Tohid Sq. East Nosrat St. Nursing and Midwifery Care Research Center.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6692 7171
Fax
+98 21 6693 3600
Email
zolfaghm@tums.ac.ir

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
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