Protocol summary

Summary
The aim of this study is to evaluate the effect of training on operating room students' anxiety during the apprenticeship time. This study is a clinical trial. The research community is formed by all the operating room undergraduate students of Semnan University of Medical Sciences. The main criterion for inclusion is the selection of training unit of the operating room. The main exclusion criterion of the study is anxiety disorders. At the beginning one of the periods engaged in studying the operating room course will be randomly selected. Sampling was census and all students in the selected course will form a sample. At first and at the beginning of the semester, the students' anxiety will be measured using the Spielberg anxiety questionnaire. Then the students were randomly divided into two groups of intervention and control in 10 people. At the beginning of the semester the training simulation will be run for the intervention group for two days. In the control group, the students will present in the training environment like past routine. In the first day of training the students’ anxiety will be assessed after the execution of simulation training in the intervention group and in the first day of apprenticeship in the control group before surgery. Also the students' anxiety will be assessed on the fifth and final day of training. Then the anxiety levels of the students in the two groups will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016021811399N3
Registration date: 2016-03-10, 1394/12/20
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-03-10, 1394/12/20
Registrant information
Name
Abbasali Ebrahimian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3107 1082
Email address
ebrahimian.aa@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of simulation training method on operating room student's anxiety during the apprenticeship time
Public title
The effect of simulation training method on student's anxiety
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the study; completing the informed consent form; the selection of the training unit of the operating room; lack of exposure to severe anxiety disorders according to the student’s statements; lack of employment in the operating room and other hospital wards. Exclusion criteria: diagnosis of anxiety disorders in the first anxiety study; reluctance to continue working.
Age
From 18 years old to 22 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, training will be done by simulation method based on the students’ curriculum in Clinical Skills Center operating room of Semnan Medical Sciences University.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Semnan University Of Medical sience
Street address
Vice chancellor for research, Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Postal code
Approval date
2016-02-09, 1394/11/20
Ethics committee reference number
IR.SEMUMS.REC.1394.155

Health conditions studied

1

Description of health condition studied
The effect of simulation training
ICD-10 code
Unspecifie
ICD-10 code description
Z55.9

Primary outcomes

1

Description
Anxiety
Timepoint
Beginning of the study, the fifth day of training, the last day of training
Method of measurement
Spielberger questionnaire

Secondary outcomes

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Intervention groups

1

Description
In the intervention group, the students will be trained in the simulation at the beginning of the semester and before going to the operating room based on their educational curriculum for two days (12 hours). The learning environment looks like a real operating room and the Master performs four selected surgeries from beginning to end based on educational curriculum and the students will be asked to complete their tasks in this surgeries.
Category
Other

2

Description
In the control group, the students go to the operating room like the prior semesters in the first day of training and will face with the actual surgery directly.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
The School of Nursing and Allied Health
Full name of responsible person
Dr Mohsen Solimani
Street address
School of Nursing and Allied Health Sciences, Km5 Damghan Road
City
Semnan

2

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Dr Darush Pahlevan
Street address
1 th Floor, Vice chancellor for research, Kosar Hospital, Basij Blvd
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr Ali Rashidi-Pour
Street address
Vice chancellor for research, Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fateme Kohsarian
Position
BS Student of operating room
Other areas of specialty/work
Street address
Student Research Committee, 1th floor, School of Nursing and Allied Health Sciences, Semnan University of medical Sciences, Km5 Damghan Road
City
Semnan
Postal code
Phone
+98 23 3365 4190
Fax
Email
f.kohsariyan@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abbasali Ebrahimian
Position
PhD of Health in Emergencies and Disasters
Other areas of specialty/work
Street address
Room #120, 1th floor, School of Nursing and Allied Health Sciences, Semnan University of medical Sciences, Km5 Damghan Road
City
Semnan
Postal code
Phone
+98 23 3365 4191
Fax
Email
aa.ebrahimian@semums.ac.irebrahimian.aa@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abbasali Ebrahimian
Position
Faculty member of Semnan University of medical Sciences
Other areas of specialty/work
Street address
Room #120, 1th floor, School of Nursing and Allied Health Sciences, Semnan University of medical Sciences, Km5 Damghan Road
City
Semnan
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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