Comparison of the effect of education based on theory of planned behavior with routine education on preventive behaviors of urinary tract infection in pregnant women referred to Zarrin Shahr health center
Comparison of the effect of education based on theory of planned behavior with routine education on adopting preventive behaviors of urinary tract infection in pregnant women in Zarrin Shahr
Design
The present study is a clinical trial with control group with parallel groups. Simple randomization method is used to assign pregnant women to intervention and control groups using random number table. Sample size in this study will be 88 persons who will be assigned to intervention and control groups with 1: 1 ratio. The study is in the phase of selecting the sample and assigning the samples to the intervention and control groups
Settings and conduct
In this study, after obtaining the necessary authorization for the research, random sampling will be conducted and for the intervention group 5 educational sessions based on the theory of planned behavior will be held in health centers of Zarrin Shahr. The control group will receive routine training.
Participants/Inclusion and exclusion criteria
Inclusion criteria included pregnant women in the first trimester of pregnancy, Having a health record in Zarinshahr health centers, no laboratory-based urinary tract infections, no chronic diseases including diabetes, no antibiotic use, and immunosuppressive drugs and consent to participate in the study
. Exclusion criteria included urinary tract infection (UTI) based on laboratory tests, chronic illnesses including diabetes, using antibiotic , and immunosuppressive drugs and lack of consent to participate in the study.
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Intervention groups
Intervention group women will receive 5 training sessions on UTI behaviors based on the theory of planned behavior. Women in the control group will receive the routine training provided at the health center.
Main outcome variables
Preventive Behaviors of Urinary Tract Infection
Prevalence of urinary tract infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170214032575N1
Registration date:2019-12-12, 1398/09/21
Registration timing:retrospective
Last update:2019-12-12, 1398/09/21
Update count:0
Registration date
2019-12-12, 1398/09/21
Registrant information
Name
fahime bagherikholenjani
Name of organization / entity
hamadan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 813838002526
Email address
f.bagheri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-19, 1398/05/28
Expected recruitment end date
2019-11-19, 1398/08/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of education based on theory of planned behavior with routine education on preventive behaviors of urinary tract infection in pregnant women referred to Zarrin Shahr health center
Public title
The effect of education on preventive behaviors of urinary tract infection in pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being in the first trimester of pregnancy
No urinary tract infection based on laboratory tests
Lack of chronic diseases such as diabetes
Not taking antibiotics and Immunosuppressive drugs
Having a health record in Zarinshahr health centers
Consent to participate in the study
Exclusion criteria:
Urinary tract infection based on laboratory tests
Having chronic diseases such as diabetes
Taking antibiotics and immunosuppressive drugs
Lack of consent to participate in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method will be used. The unit of randomization will be a person. Firstly, eligible pregnant woman will be assigned randomly to either the intervention or the control group according to the Random Number Table, and then the randomization will continue until the balance is established in terms of the size of the groups. In order to ensure allocation concealment, the central randomization method will be used so that a random sequence was given to the original researcher at one of the centers and the samplings of pregnant woman in other centers are done simultaneously. Other colleagues at other centers will contact the researcher through the telephone and ask questions about the random allocation of the pregnant woman to the intervention and control group.
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
Isfahan University of Medical Sciences
Street address
Hezarjarib Street
City
ISFAHAN
Province
Isfehan
Postal code
8174673461
Approval date
2019-08-18, 1398/05/27
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.294
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
Preventive Behaviors of Urinary Tract Infection
Timepoint
Before and three months after intervention
Method of measurement
Researcher-made questionnaire
Secondary outcomes
1
Description
Prevalence of urinary tract infection
Timepoint
Before and three months after intervention
Method of measurement
Urine culture and urine analysis test
Intervention groups
1
Description
Intervention group women will receive 5 educational sessions based on the theory of planned behavior on preventive behaviors of urinary tract infection in the prenatal care center of the health center. The educational content will also be provided in consultation with specialist groups including physicians and midwives working in health centers and health education and health promotion professionals based on the theory of planned behavior. The intervention group will also receive routine health care of health centers for pregnant women
Category
Prevention
2
Description
Control group: Pregnant women will receive routine care at health center for pregnant women, which include examining the risk signs of UTI and face-to-face training in the prevention and control of symptoms of UTIs that Provided by midwives and health care providers.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Zarinshahr Urban Health Centers covered by Isfahan University of Medical Sciences
Full name of responsible person
Hossein Shahnazi
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3243
Fax
+98 31 3668 2509
Email
h_shahnazi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Fax
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Sheida Moradpour
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 5223 2545
Email
sheida1118@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Shahnazi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8176473461
Phone
+98 31 3792 3243
Email
h_shahnazi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Shahnazi
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3243
Email
h_shahnazi@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available