Protocol summary

Study aim
Determination of the effectiveness of a training course for management of common diseases on knowledge and medication error of nurses of Akbar children hospital
Design
This clinical trial study has a control group and is conducted on 54 nurses from 9 different sections of Akbar hospital in Mashhad who are randomly selected. Twenty seven nurses receive training and 27 do not receive any training. No blinding is done in this study.
Settings and conduct
This study is conducted on 27 nurses from 9 different departments of Akbar children hospital who are randomly selected and receive training in the year 2019. Three nurses from each department , as intervention group, receive training for 3 months. To assess nurses' knowledge in the field of respective diseases, before the training and after training, a questionnaire will be prepared from the topics discussed. The average score of the nurses before and after training, and also in comparison with the control group will be reported.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All nurses with a work experience of less than 5 years who are willing to participate in the study. Exclusion criteria: Nurses who are reluctant to participate in the study
Intervention groups
Intervention group: This group consists of nurses who are randomly selected and assigned to a group which receives training. Totally, each nurse receives 3 months of technical training regarding a common disease in the related field. Control group:This group includes nurses who are randomly selected and assigned to a group which will not receive training.
Main outcome variables
Knowledge level and rate of nurses' medication error

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181213041949N1
Registration date: 2019-02-05, 1397/11/16
Registration timing: registered_while_recruiting

Last update: 2019-02-05, 1397/11/16
Update count: 0
Registration date
2019-02-05, 1397/11/16
Registrant information
Name
Ali Khakshour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3870 9200
Email address
khakshoura@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effectiveness of a training course for management of common diseases on knowledge and medication error of nurses of Akbar children hospital
Public title
Assessment of the effectiveness of a training course on knowledge and medication error of nurses
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All nurses with a work experience of less than 5 years working in Akbar Hospital
Exclusion criteria:
Nurses who are reluctant to participate
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 27
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done through table of random numbers. The researcher at first, determines the direction of reading the numbers (for example from top, bottom, left or right). Then the researcher will assign the numbers to the groups (for example odd ones to intervention group A and even ones to intervention group B)
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 Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944‎
Approval date
2018-05-23, 1397/03/02
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.296

Health conditions studied

1

Description of health condition studied
Holding a training course for management of common diseases and its effect on knowledge and medication error of nurses
ICD-10 code
Z71.9
ICD-10 code description
Counseling, unspecified

Primary outcomes

1

Description
Evaluation of nurses' knowledge level
Timepoint
Before and after the intervention
Method of measurement
Self-made questionnaire about the materials taught

2

Description
Rate of nursing errors
Timepoint
Before and after the intervention
Method of measurement
Standard questionnaire of nursing medication error validated by Baghaei et al

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Six nurses are randomly selected from each department and based on the table of random numbers are assigned to two groups of 3 people one receiving training and one without passing a course. Each nurse recieves 3 months of technical training by the responsible staff regarding a common disease (determined by the staff using available records and statistics in the related department) in the related field. Each nurse's theoretical and practical training will consist of two 3-hour training sessions each month (total of 18 hours each). In order to assess the knowledge of nurses in the field of related diseases, before and after training, a questionnaire will be provided from the topics discussed and the average score of nurses before and after training and also in comparison with the control group will be reported
Category
N/A

2

Description
Control group: Includes nurses who are randomly selected for the control group without passing a training course.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbar children hospital
Full name of responsible person
Ali Khakshour
Street address
Akbar children hospital, In front of Shahid kave 14, Shahid Kaveh sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3870 9202
Email
khakshoura@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944‎
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ali Khakshour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Akbar children hospital, In front of Shahid kave 14, Shahid Kaveh sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3870 9202
Email
khakshoura@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Khakshour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Akbar children hospital, In front of Shahid kave 14, Shahid Kaveh sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3870 9202
Email
khakshoura@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Khakshour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Akbar children hospital, In front of Shahid kave 14, Shahid Kaveh sq
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3870 9202
Email
khakshoura@mums.ac.ir

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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patients are made unidentifiable
When the data will become available and for how long
Data can be accessible 6 months after results are published
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.
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