Protocol summary

Study aim
Comparison check the effects of urology surgery technology training using lecture and Hybrided methods on self-regulated learning, clinical performance, and educational satisfaction of operating room technology students
Design
In each faculty, 20-30 students should participate in the study. Allocation of students to intervention and control groups will be done non-randomly and based on the university where they study.
Settings and conduct
The research community is the students of the sixth consecutive semester of the operating room, who have chosen the theoretical unit of gynecology and urology operating room technology and its care at the Shiraz Faculty of Nursing and the Faculty of Paramedical Sciences of Tehran University of Medical Sciences .
Participants/Inclusion and exclusion criteria
1. Continuing undergraduate students of the operating room who have chosen the theoretical unit of gynecology and urology operating room technology and its care. 2. Continuous undergraduate students of the operating room who have chosen the study unit in the field of urology. 3.Studying at Shiraz Nursing Faculty and Paramedical Sciences Faculty of Tehran University of Medical Sciences. Exit criteria: 1. Unwillingness to continue cooperation in the study 2. Absence of more than two sessions in the training course 3. Deleting a course unit while studying 4. Willingness to pass the course units in an environment other than the research environment 5. Non-participation in designated tests and incomplete completion of questionnaires
Intervention groups
In the intervention group, educational software is provided to the students so that they can use this software in addition to education through the usual method. After two months, the academic progress test will be held as a post-test.
Main outcome variables
self-regulated learning؛ clinical performance؛ educational satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240608062038N1
Registration date: 2024-06-17, 1403/03/28
Registration timing: prospective

Last update: 2024-06-17, 1403/03/28
Update count: 0
Registration date
2024-06-17, 1403/03/28
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
2025-01-20, 1403/11/01
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
Comparison check the effects of urology surgery technology training using lecture and Hybrided (lecture and mobile phone-based learning) methods on self-regulated learning, clinical performance, and educational satisfaction of operating room technology students
Public title
Comparison check the effects of urology surgery technology training using lecture and Hybrided (lecture and mobile phone-based learning) methods on self-regulated learning, clinical performance, and educational satisfaction of operating room technology students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Unwillingness to continue cooperation in the study Absence of more than two sessions in the training course Deleting a course unit while studying Willingness to pass the course units in an environment other than the research environment 5. Failure to participate in the designated tests and incomplete completion of the questionnaires
Exclusion criteria:
Willingness to pass the course units in an environment other than the research environment
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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-regulated learning
Timepoint
One week - two months
Method of measurement
Completing the questionnaire

2

Description
clinical performance
Timepoint
next semester
Method of measurement
performance observation checklist

3

Description
educational satisfaction
Timepoint
One week - two months
Method of measurement
Completing the questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: using educational software - control group: regular education. The developed educational software will be used in the test group and then its effectiveness will be evaluated. For this purpose, the researcher will refer to the educational vice-chancellor of Tehran University of Medical Sciences and the Faculty of Nursing and Midwifery of Shiraz University of Medical Sciences by submitting a letter of introduction for the necessary coordination for sampling and stating the goals of the project. Then the list of students will be obtained from the education expert of the faculty and the qualified students will enter the study after obtaining informed consent and explaining the research objectives. Students will be allocated to intervention and control groups in a non-random way and based on the university where they study. For this purpose, the students of one university will be selected as the intervention group and the students of another university will be selected as the control group. According to the Ministry of Health, Treatment and Medical Education, the curriculum unit of gynecology and urology operating room technology and its care will be presented in the form of two educational units. One unit is women's technology and another unit is urology technology. In each faculty, the topic of urology and its care is based on the surgical technology book for gynecology, obstetrics and urology surgeries (54) in the form of 8 2-hour training sessions (the second 8 sessions during the academic semester) in accordance with the Ministry of Health, Medicine and Medical Education guidelines. It is presented by the relevant lecturer and jointly between the intervention and control groups in a classroom. at the beginning of the classroom session in the control and test groups; The learning objectives of the course, the academic needs of students to pass this course and the evaluation method will be explained. A week after the start of the course, the self-regulated learning questionnaire will be provided to the students to complete; Also, in order to measure the cognitive scope of students' learning regarding urology surgery, the academic progress test will be taken as a pre-test from the students assigned to the control and test groups jointly and at the same time with similar environmental conditions in each faculty. By providing the relevant book, the students of the control groups are asked to use the designated topic of the book as an educational resource within two months. In the intervention group, the developed educational software along with username and password will be provided to the students and they will be asked to use this software based on their needs in two months along with the regular training. to use Finally, after two months, a two-hour summary meeting will be held by the primary teacher in the classroom in each faculty. At the end of the summation session (with prior notification), the academic progress test will be held as a post-test with the same conditions. Also, the students of both groups are asked to complete the self-regulated learning and educational satisfaction questionnaire. In order to evaluate the clinical performance in the implementation of urology surgical technology skills, students of both intervention and control groups in one academic semester after completing the intervention (seventh semester of students), when they were interns of the gynecology and urology operating room technology internship unit and its care. will be followed up. In both groups, an evaluator (with the same experience and skill), completes the clinical performance checklist while observing the student's performance in urology surgeries during one day of internship.
Category
Other

2

Description
Control group:Control group: The researcher will refer to the Faculty of Nursing and Midwifery of Shiraz University of Medical Sciences by presenting a letter of introduction for the necessary coordination for sampling and stating the objectives of the project. Then the list of students will be obtained from the education expert of the faculty, and qualified students will enter the study after obtaining informed consent and explaining the research objectives. According to the title of the Ministry of Health, Treatment and Medical Education, the gynecology and urology operating room technology curriculum and its care are presented in the form of two educational units, one unit of which is the topics of women's technology and the other unit of urology technology. In each faculty, the topic of urology and its care is based on the surgical technology book for gynecology, obstetrics and urology surgeries (54) in the form of 8 2-hour training sessions (8 second sessions during the academic semester) in accordance with the Ministry of Health, Medicine and Medical Education guidelines. It is presented by the relevant lecturer and jointly between the intervention and control groups in a classroom. at the beginning of the classroom session in the control and test groups; The learning objectives of the course, the academic needs of students to pass this course and the evaluation method will be explained. A week after the start of the course, the self-regulated learning questionnaire will be provided to the students to complete; Also, in order to measure the cognitive scope of students' learning regarding urology surgery, the academic progress test will be taken as a pre-test from the students assigned to the control and test groups jointly and at the same time with similar environmental conditions in each faculty. By providing the relevant book, the students of the control groups are asked to use the designated topic of the book as an educational resource within two months. . Finally, after two months, a two-hour summary meeting will be held by the primary teacher in the classroom in each faculty. At the end of the summation session (with prior notification), the academic progress test will be held as a post-test with the same conditions. Also, the students of both groups are asked to complete the self-regulated learning and educational satisfaction questionnaire. In order to evaluate the clinical performance in the implementation of urology surgical technology skills, students of both intervention and control groups in one academic semester after completing the intervention (seventh semester of students), when they were interns of the gynecology and urology operating room technology internship unit and its care. will be followed up. In both groups, an evaluator (with the same experience and skill), completes the clinical performance checklist while observing the student's performance in urology surgeries during one day of internship.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Nursing Faculty - Faculty of Paramedical Sciences, Tehran University of Medical Sciences
Full name of responsible person
Somayeh Gheisari
Street address
Namazi square- Faculty of Nursing
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
somayeh.gh65@yahoo.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?
No
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
Somayeh Gheisari
Position
Instructor of Operating room
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
somayeh.gh65@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Somayeh Gheisari
Position
Instructor of Operating room
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
somayeh.gh65@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Somayeh Gheisari
Position
Instructor of Operating room
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
somayeh.gh65@yahoo.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 and Tehran 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- To assure 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- Adherence 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.
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