Protocol summary

Study aim
Determining the impact of electronic training on patient safety principles on the level of nurses' safety culture and compliance with patient safety by nurses of Imam Reza Hospital
Design
A clinical trial with a control group, with parallel groups, which will be assigned to two control and intervention groups by a simple random method by tossing a coin on 60 nurses who are available.
Settings and conduct
This study will be conducted on 60 nurses of (ICU-CCU-Emergency) departments of Imam Reza Hospital (AS) in Tehran. Before the intervention, the personal information form, patient safety culture assessment questionnaire and patient safety questionnaire are completed by the nurses of the intervention and control groups. Individual training program in the form of a face-to-face session for nurses of both test and control groups, 6 2-hour multimedia sessions (CD containing voiced PowerPoint) during 6 weeks only in The discretion of the test group is to be used at home. will be completed. No intervention will be done for this group.
Participants/Inclusion and exclusion criteria
Entry requirements: willingness to participate in the study, having at least one year of work experience in the nursing profession, having a university education in the field of nursing, access to electronic tools Failure to enter: Not having the disease of Covid-19 and being sick
Intervention groups
Intervention group: The educational content in 6 2-hour sessions in multimedia format (CD containing voiced PowerPoint) during 6 weeks (one CD per week) was provided only to the test group for use at home. Three shifts were done. Also, by considering a group in virtual space approved by Aja University of Medical Sciences, it was possible to ask questions about ambiguities. Control group: no intervention was done for this group.
Main outcome variables
Patient safety culture; patient safety

General information

Reason for update
Acronym
کارآزمایی کنترل شده تصادفی
IRCT registration information
IRCT registration number: IRCT20221129056661N1
Registration date: 2023-01-11, 1401/10/21
Registration timing: registered_while_recruiting

Last update: 2023-01-11, 1401/10/21
Update count: 0
Registration date
2023-01-11, 1401/10/21
Registrant information
Name
sepideh faridi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4382 3484
Email address
sepideh_faridi2@outlook.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-21, 1401/09/30
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of E-learning of Patient Safety Principles on Safety Culture and Patient Safety by Nurses in Imam Reza Hospital
Public title
The Effect of E-learning of Patient Safety Principles on Safety Culture and Patient Safety by Nurses in Imam Reza Hospital
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Having work experience in the nursing profession for at least one year Working in the current department of the place of service for at least one month Having a university education in the field of nursing Failure to pass a training course in the field of safety culture and patient safety in the last 6 months Access to electronic tools for learning with Windows program
Exclusion criteria:
Not having the disease of Covid-19 and being sick
Age
From 23 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The nurses of the departments (ICU-CCCU-Emergency) will be assigned to two groups of 30 test persons and 30 control persons by a simple random method by tossing a coin.
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
Ethics Committee of the University of Medical Sciences of the Islamic Republic of Iran Army
Street address
13th floor, Block A, Treatment and Medical Education, Central Headquarters of the Ministry of Health, Simai Iran St., between South Flamak and Zarafshan, Quds town,
City
تهران
Province
Tehran
Postal code
1613918151
Approval date
2021-08-30, 1400/06/08
Ethics committee reference number
IR.AJAUMS.REC.1400.068

Health conditions studied

1

Description of health condition studied
Patient safety culture
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Patient safety culture score
Timepoint
Before the intervention and 14 days after the intervention
Method of measurement
Patient safety culture questionnaire

2

Description
Compliance with patient safety
Timepoint
Before the intervention and 14 days after the intervention
Method of measurement
Patient safety compliance questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Individual training program in the form of a face-to-face meeting to introduce, express the goals and title separately for the nurses of the intervention group, 6 sessions of 2 hours in multimedia (CD containing voiced PowerPoint) during 6 weeks (one CD per week) It will only be available to the test group for use at home
Category
N/A

2

Description
Control group: The training program will be presented separately for the control nurses in the form of an in-person meeting to introduce, state the goals and the title, and no intervention will be done for the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital, Aja University of Medical Sciences
Full name of responsible person
Dr. Mojtabi Yousefi Zashak
Street address
Sarhang Etemadzadeh Street, North Kargar Street,
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6350
Email
Sh.aliyari@ajaum.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Reza Mosaed
Street address
Army University of Medical Sciences, Serhang Etemadzadeh Street, West Fatemi Street, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
reza.mosaed@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Sepideh Faridi
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Aja College of Nursing, Kaj Street, Shariati Street
City
Tehran
Province
Tehran
Postal code
1613918151
Phone
+98 21 7750 7400
Email
sepideh_faridi2@outlook.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Sepideh Faridi
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Aja College of Nursing, Kaj Street, Shariati Street
City
Tehran
Province
Tehran
Postal code
1613918151
Phone
+98 21 7750 7400
Email
sepideh_faridi2@outlook.com

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Sepideh Faridi
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Aja College of Nursing, Kaj Street, Shariati Street
City
Tehran
Province
Tehran
Postal code
1613918151
Phone
+98 21 7750 7400
Email
sepideh_faridi2@outlook.com

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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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