Protocol summary

Summary
. This quasi-experimental study was carried out with the participation of 200 pregnant women to come to (visit) Urban health centers in Bushehr . The study aimed to examine effect of health education based on the Health Belief Model on promotion Preventive behaviors of vaginal infection in pregnant women. Inclusion criteria included: a minimum literac; lack of self- reported Vaginitis ; gestational age 13 to 32 weeks and had low-risk pregnancy. Exclusion criteria included : the unwillingness of people to continue to participate in the study and was absence of a training session. Eligible pregnant women were randomly allocated to intervention group (n=100) who received the education program based Health Belief Model and control group (n=100) who don’t received education Except prenatal care. Random sampling was continuous . Two training sessions for the intervention group was held on the basis of the Health Belief Model. After the training sessions booklet and pamphlet provides both intervention and control groups . After 6 weeks, a second questionnaire was completed by both groups .

General information

Acronym
HBM
IRCT registration information
IRCT registration number: IRCT201509204785N18
Registration date: 2016-04-26, 1395/02/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-26, 1395/02/07
Registrant information
Name
Seyedeh Tahereh Mirmolaei
Name of organization / entity
Nursing and Midwifery Faculty - Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982166927171- 00982166937120
Email address
mirmolaei@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of health education based on the Health Belief Model on promotion Preventive behaviors of vaginal infection in pregnant women
Public title
The effect of education on behavior
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:have at least read and write;13 to 32 weeks gestational age; low-risk pregnancy;The lack of vaginitis Exclusion criteria :Failure to attend a training session;The unwillingness of people to continue 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: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Nursing and Midwifery Faculty - Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2014-04-14, 1393/01/25
Ethics committee reference number
93-01-25-25215-111382

Health conditions studied

1

Description of health condition studied
vaginal infection
ICD-10 code
P01.1
ICD-10 code description
Fetus and newborn affected by premature rupture of membranes

Primary outcomes

1

Description
Behavior
Timepoint
6 weeks after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Knowledge
Timepoint
At baseline and 6 weeks after intervention
Method of measurement
Questionare

Intervention groups

1

Description
In the intervention group were given two training sessions on Health Belief Model and then boklet and pamphlets made using the Health Belief Model was delivered to the intervention group .intervention group also received routine perinatal care
Category
Behavior

2

Description
In the control group only booklet and pamphlet was delivered and was receiving routine prenatal care .
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Nbie Akram Medical Health Center
Full name of responsible person
Maryam Baharestani
Street address
Business alley، Motahari street، bosher
City
Bushehr

2

Recruitment center
Name of recruitment center
Khybar Medical Health Center
Full name of responsible person
Hassane Dareshori
Street address
Khybar alley، Ashori street، Bushehr
City
Bushehr

3

Recruitment center
Name of recruitment center
Hafte Tir Medical Health Center
Full name of responsible person
Zinate Sarkhosh
Street address
Hafte Tir alley،Sangi street، bosher
City
Bushehr

4

Recruitment center
Name of recruitment center
Shahid Beheshti Medical Health Center
Full name of responsible person
Ketayon Alibashi
Street address
Khageha
City
Bushehr

5

Recruitment center
Name of recruitment center
Shohada Medical Health Center
Full name of responsible person
Sahame Ale Kasire Farhani
Street address
Beheshte Sadegh street،Bushehr
City
Bushehr

6

Recruitment center
Name of recruitment center
Ghods Medical Health Center
Full name of responsible person
Lila Savameri
Street address
Sabzabad street، bosher
City
Bushehr

7

Recruitment center
Name of recruitment center
Hazrate Zinab Medical Health Center
Full name of responsible person
Farzane Agha
Street address
Davas street،Bousher
City
Bushehr

8

Recruitment center
Name of recruitment center
Ali Ebne Abitaleb Medical Health Center
Full name of responsible person
Sodabe Zalpour
Street address
Koti quarter، Bushehr
City
Bushehr

9

Recruitment center
Name of recruitment center
Sahebalzeman Medical Health Center
Full name of responsible person
Rahime Galilvand
Street address
Solhabad Street،Bushehr
City
Bushehr

10

Recruitment center
Name of recruitment center
Mehrag Medical Health Center
Full name of responsible person
Azare Tabarestani
Street address
Ashori street،Bushehr
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoude yonesian Dr
Street address
Deputy of research and technology-6th floor - Ghods street - Keshavarz Bolvar
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sayed Tahere Mirmolaei
Position
Masters/Faculty member
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty - Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
00982166927171-00982166937120
Fax
+98 912 224 5100
Email
mirmolaei@sina.tums.ac.ir st_mirmolaei@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyedeh Tahereh Mirmolaie
Position
Master/Faculty member
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty - Tehran University of Medical Sciences
City
Tehran
Postal code
iran
Phone
00982166927171-00982166937120
Fax
00982166933700 - 00982166904252
Email
mirmolaei@sina.tums.ac.ir st_mirmolaei@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Salime Mohammadi
Position
Masters
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty - Tehran University of Medical Sciences
City
Tehran
Postal code
iran
Phone
00
Fax
Email
salime31@yahoo.com
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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