Protocol summary

Study aim
Determine the effect of designed training program based on ADDIE model on nurses’ performance regarding transfusion of blood and blood products for child.
Design
Randomized, Field trial with parallel groups, one-way blind on 60 nurses. Simple randomization with spinning coins was assigned to the intervention and control groups.
Settings and conduct
The study was performed on pediatric nurses at Bint Al-Huda Hospital in Nasiriyah, Iraq. Subjects under intervention are randomly divided into two groups of intervention and control. In the intervention group, after holding three appropriate training sessions for nurses in case of blood transfusion and blood products, the performance of nurses before, during and after blood transfusion was performed by the researcher using a checklist. The control group, as usual, performed the section on blood transfusion and their function was believed by the researcher as observed by a checklist, and then the data is analyzed using SPSS software and performed with modification. Becomes.
Participants/Inclusion and exclusion criteria
The inclusion criteria are at least of 6 months of work experience in the pediatric wards, not participation in training program about transfusion of blood and blood products previously and tendency to participation in the study. The exclusion criterion was the change in nurses' workplace during the study; Nurses' absence from attending more than one session of training sessions.
Intervention groups
In intervention group, for nurses, three training sessions are held using the ADDIE model, then the performance of nurses before, during and after blood transfusion to the child is monitored and evaluated by the researcher using a checklist.
Main outcome variables
Nurses’ performance regarding transfusion of blood and blood products for child, before, during and after transfusion.

General information

Reason for update
Acronym
EPNPTB
IRCT registration information
IRCT registration number: IRCT20210718051933N1
Registration date: 2021-08-12, 1400/05/21
Registration timing: prospective

Last update: 2021-08-12, 1400/05/21
Update count: 0
Registration date
2021-08-12, 1400/05/21
Registrant information
Name
Reyam Abbas
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3854 2022
Email address
abbasr982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-01, 1400/06/10
Expected recruitment end date
2021-10-02, 1400/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Designed Training Program based on ADDIE model on Nurses’ Performance regarding Transfusion of Blood and Blood products for Child
Public title
Effect of Designed Training Program based on ADDIE model on Nurses’ Performance regarding Transfusion of Blood and Blood products for Child
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
he inclusion criteria are at least of 6 months of work experience in the pediatric wards not participation in training program about transfusion of blood and blood products previously tendency to participation in the study.
Exclusion criteria:
The exclusion criterion was the change in nurses' workplace during the study. Nurses' absence from attending more than one session of training sessions.
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
Pediatric wards in Bint-Al-Huda teaching hospital at Al Nasiriya City with simple randomization with flipping coin, assigned to intervention and control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Analysts are unaware of the division of the control and intervention group.
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
Ibn Sina َAve; Doctora intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2021-07-06, 1400/04/15
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.035

Health conditions studied

1

Description of health condition studied
Nurses’ Performance regarding Transfusion of Blood and Blood products
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Nurses’ performance regarding transfusion of blood and blood products for child, before, during and after transfusion.
Timepoint
before, during and after transfusion.
Method of measurement
The filled observation checklist of nurses’ performance regarding transfusion of blood and blood products is analyzed.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this stage, researchers prepare a set of goals for before, during and after BT administration for nurses' performance with emphasis on nurses' error in this regard. The training program will be carried out through three successive sessions. The content of this training includes the necessary information about blood and blood products, blood functions, signs and contraindications for blood transfusions, complications of blood transfusions, manifestations of blood transfusion reactions, and the role of nurses during blood transfusions. It also explains the precautionary measures before and after the injection, a general guide to managing the side effects of blood transfusion reactions. Each session will last approximately 2 hours and will last for 2 weeks. Then the performance of nurses before, during and after the intervention is evaluated by the nurse using an observational checklist. In order to confirm the nurse's performance, her performance is evaluated in 2 patients.
Category
Behavior

2

Description
Control group: In this group, nurses perform blood transfusions and blood products according to routine and the performance of nurses during and before and after blood transfusion on two patients is evaluated by an observational checklist by the researcher.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Bent Alhuda Hospital
Full name of responsible person
Rashid Al-Khalidi
Street address
Nasiriyah, Dhi Qar, Iraq
City
Nasiriyah
Postal code
0000000000
Phone
+964 23 607 2695
Email
ca.iqhealth15@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Daneshgah Ave; across of Daneshgah 18 Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresraech@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
Monir Ramezani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Ave., Doctora intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ramezanimn@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Monir Ramezani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina َAve; Doctora intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ramezanimn@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Monir Ramezani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina َAve; Doctora intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
ramezanimn@mums.ac.ir

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
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
Not applicable
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