Determining the effect of non-technical skills training on the level of self efficacy and safety climate in the scrub personnel
Design
The clinical trial has a control group with one side unreasoning and randomized parallel groups of 60 scrub personnel. Randomize selected hospitals using the coin method and for random selection of samples in each selected Hospital. A table of random numbers is used.
Settings and conduct
The study was conducted in Al-Zahra and Amin hospitals using the coin method, with one of the hospitals as the intervention group hospital; The other was selected as the control group hospital. By using the random number table method, 30 scrub personnel from each Hospital are selected. The intervention group receives two sessions of two-hour non-technical skills training, and the Control group does not receive the intervention. This study is single-masked, and the statistical analyst is blinded. For collection, the data uses electronic questionnaires of self efficacy, safety climate and demographic information before and one month after the intervention to be used.
Participants/Inclusion and exclusion criteria
All the studied samples have full consent to participate in the study; All the studied samples that have at least six months left of their years of service and workforce planning period; All the studied samples should have at least six months of work experience in their current workplace; All the studied samples have the experience of contributing to non-technical skills training programs.
Intervention groups
The intervention group receives two two-hour non-technical skills training sessions through video scenarios and lectures; The control group will not receive any intervention.
Main outcome variables
The average self efficacy score; The average score of the safety climate in scrub personnel
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150715023216N15
Registration date:2023-08-05, 1402/05/14
Registration timing:prospective
Last update:2023-08-05, 1402/05/14
Update count:0
Registration date
2023-08-05, 1402/05/14
Registrant information
Name
Said Amini Rarani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3522 6158
Email address
ghadami@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-09-12, 1402/06/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of non-technical skills training on the level of self efficacy and safety climate in the scrub personnel
Public title
Investigating the effect of non-technical skills training on the level of self efficacy and safety climate
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All the studied samples have full consent to participate in the study
All the studied samples that have at least six months left of their years of service and workforce planning period
All the studied samples should have at least six months of work experience in their current workplace
Exclusion criteria:
All the studied samples who have the experience of contributing to non-technical skills training programs
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Among the two selected hospitals (Al-Zahra Hospital and Amin Hospital) using the coin randomization method, one of the hospitals was the intervention group and the other Hospital is selected as the control group. In such a way that one of the hospitals is the head of the coin and the other is the tail, and throw the coin, each of the hospitals that came, that Hospital as the Hospital of the intervention group and the other Hospital is selected as the Hospital of the control group. In the next step, 30 scrub staff in each Hospital are selected. The number of scrub personnel in the elective operating room 1 of Al-Zahra Hospital is 80 people, and the number of scrub personnel in the operating room at Amin Hospital has 54 people. In order to randomly select 30 scrub staff from each of these hospitals from the table, Random numbers are chosen. For this purpose, each of the 80 scrub personnel at Al-Zahra Hospital and 54 at Amin Hospital will be assigned a number. These numbers are between 01 and 80 in Al-Zahra Hospital and in Amin Hospital will be between 01 and 54. Then, in the table of random numbers, consider the two digits on the right side of the numbers and line up the columns with eyes closed. Alternatively, we move the rows of the pencil tip table so that 30 numbers are selected for the intervention group. This act for the hospital group Control is done definitely. For Al-Zahra Hospital, the numbers that correct two digits on the right that are greater than 80 and less than 01, For Amin Hospital, the numbers that correct two digits on the right that are greater than 54 and less than 01 are ignored. It is also forbidden to re-select the numbers that correct two digits are repeated.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the data analyst compared which patients were in the intervention group and those in the control group will not be conversant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-06-25, 1402/04/04
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.044
Health conditions studied
1
Description of health condition studied
Self efficacy
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Safety climate
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The average score of self efficacy in the researcher-made questionnaire of self efficacy in non-technical skills of a scrub person
Timepoint
Measuring the average score of self efficacy at the beginning of the study (before the intervention) and one month after the intervention
Method of measurement
Researcher-made questionnaire of self efficacy in non-technical skills of a scrub person
2
Description
The average safety climate score in the Nordic Safety Climate Questionnaire-50(NOSACQ-50)
Timepoint
Measuring the average safety climate score at the beginning of the study (before the intervention) and one month after the intervention
Method of measurement
Nordic Safety Climate Questionnaire-50(NOSACQ-50)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this research phase, the researcher conducted two sessions of two-hour training in the operating room environment for the samples of the intervenes group, and the researcher provided training. These meetings are arranged by telephone in advance with samples On sample working days, the intervention group will be held before the start of surgery so that it does not interfere with their working conditions. First session until completion the training continues for all samples of the intervention group, and the second training session is held. In the first training session, first Situational awareness and task management skills are taught to the samples for one hour each. Second, communication skills and teamwork are taught in the session for two hours. The researcher in each of the training sessions first Defines the skill and then explains and clarifies it further by playing prepared videos and giving objective and practical examples makes more, If a sample is removed from the study before the first training session, the researcher will replace him, but in the case of samples that are excluded from the study after the first training session, there is no possibility of replacement.
Category
Behavior
2
Description
Control group: This group will not receive any intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Ahmad Ghadami
Street address
Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7583
Email
ghadami@mui.ac.ir
2
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Masoumeh Mohammadi
Street address
Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7583
Email
masoomemohammadi13755@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7500
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Ghadami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7583
Email
ghadami@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Ghadami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7583
Email
ghadami@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoumeh Mohammadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3028
Email
masoomemohammadi13755@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
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