Comparing virtual and real simulators of the operating room environment for managing nursing students' self-confidence and anxiety in the first experience of operating room
Comparing virtual and real simulators of the operating room environment for managing nursing students' self-confidence and anxiety in the first experience of operating room
Design
Nursing students will be considered non-randomly in the first semester as the control group and nursing students in the second semester as the intervention group. In the intervention group, an operating room simulator will be used for training.
Settings and conduct
The virtual simulator developed in Hazrat Fatemeh (S) Shiraz College of Nursing and Midwifery will be evaluated.
Participants/Inclusion and exclusion criteria
1. Nursing undergraduate students
2. Choosing a study unit in the field of adults 1
3. Willingness to participate in the study
Intervention groups
In the intervention group (nursing students in the second semester), training before attending the operating room is based on the use of virtual simulation (virtual tour of the operating room), which is available to them via mobile phone two days before entering the operating room. will be placed and students will interact with the operating room environment through the simulator.
Main outcome variables
self-confidence؛ anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240608062038N2
Registration date:2024-06-18, 1403/03/29
Registration timing:prospective
Last update:2024-06-18, 1403/03/29
Update count:0
Registration date
2024-06-18, 1403/03/29
Registrant information
Name
Somayeh Gheisari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
somayeh.gh65@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-07-21, 1404/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing virtual and real simulators of the operating room environment for managing nursing students' self-confidence and anxiety in the first experience of operating room
Public title
Comparing virtual and real simulators of the operating room environment for managing nursing students' self-confidence and anxiety in the first experience of operating room
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Nursing undergraduate students
Choosing a study unit in the field of adults 1
Student of Hazrat Fatemeh (S) Faculty of Nursing and Midwifery, Shiraz
Willingness to participate in the study
Exclusion criteria:
Having previous experience of being in the operating room environment
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Faculties of nursing and midwifery, management and medical information - Shiraz University of Medica
Street address
Namazi square- Faculty of Nursing
City
Shiraz
Province
Fars
Postal code
71936-13119
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1403.006
Health conditions studied
1
Description of health condition studied
Education of students
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
self-confidence
Timepoint
Before the start of training - the first day of training - the end of training
Method of measurement
Rosenberg self-esteem scale
2
Description
anxiety
Timepoint
Before the start of training - the first day of training - the end of training
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: After explaining the objectives of the research and obtaining consent from the participants, the students of both the control and intervention groups will complete the study questionnaires. Then the training in the intervention group will be done in a virtual way. In the intervention group, the training is based on the use of virtual simulation (virtual tour of the operating room), which will be provided to them via mobile phone two days before entering the operating room, and the students will familiarize themselves with the operating room environment through the simulator. will interact. After the educational interventions, the students of both the intervention and control groups enter the real operating room and perform their routine tasks in the internship. At the end of the first day, both groups will complete the study questionnaires. Finally, on the last day of the study, the questionnaires of this study will be completed again by the students of both groups.
Category
Other
2
Description
Control group: After explaining the objectives of the research and obtaining consent from the participants, the students of both the control and intervention groups will complete the study questionnaires. Then the training will be done in the control group based on the usual method and in the intervention group in a virtual method. In this way, two days before entering the operating room, the students of the control group, by attending the practical environment (real simulation) according to the usual routine, receive the necessary explanations about the environment of the operating room and the relevant rules from their professor. After the educational interventions, the students of both the intervention and control groups enter the real operating room and perform their routine tasks in the internship. At the end of the first day, both groups will complete the study questionnaires. Finally, on the last day of the study, the questionnaires of this study will be completed again by the students of both groups.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz School of Nursing
Full name of responsible person
Mehdi Hasanshahi
Street address
Namazi square - Faculty of Nursing
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
mhdi.hasanshahi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohamad Hashem Hashempour
Street address
Shiraz - Zand St. - next to Red Crescent - central building of Shiraz University of Medical Sciences - 7th floor
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Hasanshahi
Position
Instructor of operating room group
Latest degree
Master
Other areas of specialty/work
Others
Street address
Namazi square - Faculty of Nursing
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
mhdi.hasanshahi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Hasanshahi
Position
Instructor of operating room group
Latest degree
Master
Other areas of specialty/work
Others
Street address
Namazi square - Faculty of Nursing
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
mhdi.hasanshahi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Hasanshahi
Position
Instructor of operating room group
Latest degree
Master
Other areas of specialty/work
Others
Street address
Namazi square- Faculty of Nursing
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
mhdi.hasanshahi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
1- Obtaining the code of ethics from the Research Vice-Chancellor of Shiraz University of Medical Sciences 2- Obtaining a letter of introduction from the Research Vice-Chancellor of Shiraz University of Medical Sciences and presenting it to the Educational Vice-Chancellor of Shiraz University of Medical Sciences 3- Providing an explanation to all research units about the objectives and how to implement it 4- Obtaining informed consent at the beginning of the study from the research units 5- Keeping in mind the willingness of the research units to participate in the research and informing them about the possibility of withdrawing at any stage of the study without any penalty or impact on their academic evaluation 6- Reassuring the research units that the information obtained is confidential and only general results will be published 7- Respecting the rights of colleagues in all publications resulting from this research 8- Adhering to the principles of Helsinki ethics
When the data will become available and for how long
The storage period of study data is about two years.
To whom data/document is available
Research units
Under which criteria data/document could be used
If the research participants request to know their educational status
From where data/document is obtainable
Executive in charge of the research project
What processes are involved for a request to access data/document
The contact number and email of the responsible executive will be provided to the participants.