Protocol summary

Study aim
The aim of the present research is to investigate the effect of training intervention based on Gagne's model on awareness, performance and decision making power of mothers of young children regarding the management of domestic injuries.
Design
In this research, 110 eligible mothers of young children referring to kindergartens were chosen. then participant were randomly divided into two control and intervention groups.
Settings and conduct
For implementation of this study, in coordination with the management of the selected kindergarten, an invitation will be sent to mothers. At first, the mothers will receive a full description of the implementation of the present study. In this study, for the participant in the intervention group, training sessions will be held based on Gagne's model. There is no blinding for this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria include mothers of young children (3 to 6 year old); a minimum level of education for mothers, high school diploma; consent to participate in the study; mother's health in terms of psychological disorders, communication problems and physical disability; child's health in terms of psychological disorders, developmental, physical, and cognitive delays; parents' employment and education in non medical sciences; and the exclusion criterion is the subject’s dissatisfaction with either participating or continuing to participate in the research.
Intervention groups
The intervention group is the mothers who will have training sessions using the steps in the model of Gagne about domestic injuries in young children for them. The control group is a participant who does not receive any intervention in this study.
Main outcome variables
Anticipated consequences are enhanced awareness and decision making power of mothers along with improved performance of them in preventing and managing domestic injuries and effectively memorizing the training content after 21 days of the training intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151019024594N2
Registration date: 2017-12-31, 1396/10/10
Registration timing: registered_while_recruiting

Last update: 2017-12-31, 1396/10/10
Update count: 0
Registration date
2017-12-31, 1396/10/10
Registrant information
Name
Seyedeh Zahra Shafipour
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3344 0202
Email address
shafipur@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expenditures approved in the Proposals paid through the government system (Guilan University of Medical Sciences).
Expected recruitment start date
2017-12-26, 1396/10/05
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Training Intervention Based on Gagne's Model on Knowledge, Performance, and Decision Making Power of Mothers of young children Regarding Management of Domestic Injuries
Public title
Effect of Training Mothers of young children Based on Gagne's Model Regarding Management of Domestic Injuries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers of young children (3 to 5 year old) A minimum level of education for mothers, high school diploma Consent to participate in the study Mother's health in terms of psychological disorders, communication problems and physical disability Child's health in terms of psychological disorders, developmental, physical, and cognitive delays Parents' employment and education in non medical sciences
Exclusion criteria:
Dissatisfaction with participating in any stage of the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
After getting the necessary permissions from the authorities in question and getting consent from the mothers for participating in the study, the kindergartens of Rasht and the samples will be selected randomly using a two stage cluster sampling. In the first stage, cluster sampling will be conducted using the list obtained from Guilan Welfare Organization, according to which 132 active kindergartens work in Rasht, and according to random numbers table and from each geographical point of Rasht (north, south, center, east and west), one kindergarten will be selected as the intervention and one kindergarten as a the control. Overall, 10 kindergartens will be sampled for intervention and control groups. Then, in the second stage of cluster sampling, in the selected kindergartens, given the register and with the help of random numbers table, the children from 3 to 5 will be selected and by holding a meeting to introduce the present study, we will talk with the mothers of these children on the participation in the study. Finally, in each of the two intervention and control groups, 55 subject with the inclusion criteria will be selected.
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 Guilan University of Medical Sciences
Street address
Deputy of research and technology, Shahid Siadati St., Namjoo Ave, Guilan, Rasht, Islamic Republic of Iran
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2017-11-25, 1396/09/04
Ethics committee reference number
IR.GUMS.REC.1396.337

Health conditions studied

1

Description of health condition studied
burning
ICD-10 code
T29
ICD-10 code description
Injury, poisoning and certain other consequences of external causes

2

Description of health condition studied
poisoning
ICD-10 code
X40
ICD-10 code description
External causes of morbidity and mortality

3

Description of health condition studied
fall
ICD-10 code
W13
ICD-10 code description
External causes of morbidity and mortality

4

Description of health condition studied
choking
ICD-10 code
W79
ICD-10 code description
External causes of morbidity and mortality

Primary outcomes

1

Description
Knowledge score of mothers of young children in researcher made questionnaire
Timepoint
Before the intervention, immediately after the intervention and 21 days after the intervention
Method of measurement
questionnaire

2

Description
Performance score of mothers of young children in researcher made questionnaire
Timepoint
Before the intervention, immediately after the intervention and 21 days after the intervention
Method of measurement
questionnaire

3

Description
Decision making power score of mothers of young children in researcher made questionnaire
Timepoint
Before the intervention, immediately after the intervention and 21 days after the intervention
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:In this research, intervention is an educational type. Training sessions will be held for mothers of the intervention group for two sessions in two consecutive days in groups of 5 or 6, and for 90 minutes, using Gagne's model step by step protocols for home injuries in young children. According to the pediatric medical and nursing resources and researches, injuries of falling and falling, poisoning, burning, foreign body swallowing, and choking are the most common domestic injuries in young children, so in this study, these same injuries are also taught to teach how Prevention of injury and training after they occur. It should be noted that on the first day of training the goals associated with burn injuries and falling from the high and on the day two goals associated with the damage to the poisoning and ingestion of foreign body and choking will be implemented.
Category
Prevention

2

Description
Control group: The mothers in control group will not be provided with any training course. However, following the end of the training sessions for the mothers in intervention group, for ethical reasons, the training booklet will be further provided to the mothers in control group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Kindergartens
Full name of responsible person
General manager of State Welfare Organization of Guilan Province
Street address
State Welfare Organization of Guilan Province, Parastar Street, Rasht, Guilan, Islamic Republic of Iran
City
Rasht
Province
Guilan
Postal code
413451833
Phone
+98 13 3332 4505
Email
modiriat@behzisty-guilan.ir
Web page address
http://behzisty-guilan.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Research and Development Deputy of Gilan University of Medical Sciences, Shahid Siadati St., Namjoo Street, Rasht, Guilan, Islamic Republic of Iran
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5820
Fax
+98 13 3333 6395
Email
nemati@gums.ac.ir
Web page address
http://www.gums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Shafipour
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Faculty of Nursing and Midwifery, Student Street, Shahid Beheshti Highway, Rasht, Guilan, Islamic Republic of Iran
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3355 5058
Fax
+98 13 3355 0097
Email
shafipur@gums.ac.ir
Web page address
http://www.gums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Shafipour
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Faculty of Nursing and Midwifery, Student Street, Shahid Beheshti Highway, Rasht, Guilan, Islamic Republic of Iran
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3355 5058
Fax
+98 13 3355 0097
Email
shafipur@gums.ac.ir
Web page address
http://www.gums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Neda Asadollahzadeh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Faculty of Nursing and Midwifery, Student Street, Shahid Beheshti Highway, Rasht, Guilan, Islamic Republic of Iran
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3360 2442
Fax
Email
hamsangar.kdm@gmail.com
Web page address
http://www.gums.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
Undecided - It is not yet known if there will be a plan to make this available
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