Protocol summary

Summary
This research is a quasi-experimental design with aim to determine the effect of education based on the theory of planned behavior in mothers with girls under the two years old in promoting preventive behaviors of urinary tract infection. This study that was carried out on 110 mothers who have girls under the two years old 2 years in referring to health centers of Arak were participated. Sampling randomly in two case and control groups (each of groups was 55 mothers). Inclusion criteria was having a literacy and exclusion of criteria was unwillingness to continue participation in this study or being absent for more than two session in educational classes. Data were collected with a questionnaire based on Theory of Planned Behavior. Then intervention was done during 4 sessions, with lectures, group discussions, movie show and booklet material for case group about education of preventive urinary tract infection in children. In the control group, the researcher does not do any educational intervention. Data again were collection and then analyze 3 month after intervention in both groups. In this study primary outcome is adoption of preventive behaviors of urinary tract infection among in mothers with girls under the two years old. Secondary outcomes is Knowledge, Attitudes, subjective norms, perceived behavioral control and behavioral intention

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017031533090N1
Registration date: 2017-07-09, 1396/04/18
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-07-09, 1396/04/18
Registrant information
Name
Zahra Ahmadi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 956 0186
Email address
zahra.ahmadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Office of the Vice-chancellor for Research of Arak University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-11-24, 1396/09/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of mothers' education based on the theory of planned behavior on prevention of urinary tract infection on their under two years old daughters
Public title
Effect of mothers' education on prevention of urinary tract infection on their under two years old daughters
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Literate mothers of children under two years who referring to health centers of Arak.Exclusion criteria: mother's unwillingness to continue participation in this study; being absent more than two session in educational classes.
Age
From 18 years old to 50 years old
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
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
Arak University of Medical Sciences
Street address
Arak، Basij Square, pardis Educational Complex, Department of Education and Research
City
arak
Postal code
38481-7-6941
Approval date
2017-01-30, 1395/11/11
Ethics committee reference number
IR.ARAKMU.REC.1395.377

Health conditions studied

1

Description of health condition studied
Urinary tract infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified

Primary outcomes

1

Description
Adopt behaviors to prevent of of urinary tract infectio in children.
Timepoint
Before and after the intervention.
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Knowledge؛ Attitude؛ Subjective norms؛ Perceived behavioral control and behavioral intention
Timepoint
Before and after the intervention.
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention 1: Education based on Theory of Planned Behavior in intervention group for 4 educational sessions according to the needs; 1 hour via lecture and discussion using training manual and etc. with data collection through questionnaire before and 3 months after the intervention
Category
Behavior

2

Description
In the control group: the researcher does not do any educational intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
arak Health Centers
Full name of responsible person
zahra ahmadi
Street address
Department of Public Health, Golestan, Mustafa Khomeini, Arak
City
arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Dr Ali Ghazavi
Street address
Vice chancellor for research, Arak University of Medical Sciences, Pardis Educational complex, Basij Square, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Department of Health Education and Health Promotion , Arak University of Medical Sciences
Full name of responsible person
Zahra Ahmadi
Position
MSc student
Other areas of specialty/work
Street address
Department of Health Education and Health Promotion, Golestan Street, Arak
City
Arak
Postal code
3816635341
Phone
+98 86 3368 4615
Fax
Email
ahmadizahra313@gmail.com; zahra.ahmadi@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohsen Shamsi
Position
PhD
Other areas of specialty/work
Street address
Golestan Street, School of health, Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 863684615
Fax
+98 86 3368 6443
Email
mohsen_shamsi1360@yahoo.com ; dr.shamsi@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Health, Arak University of Medical Sciences
Full name of responsible person
Zahra Ahmadi
Position
MSc student
Other areas of specialty/work
Street address
School of Health, Golestan Street, Arak
City
Arak
Postal code
Phone
+98 86 3368 4615
Fax
Email
ahmadizahra313@gmail.com;zahra.ahmadi@arakmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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