1. Home
  2. Approved trials
  3. » فارسی

The effect of theory-based educational intervention on behaviors of prenatal care in pregnant women referred to health centers in Iranshahr

Protocol summary

Summary
The aim of this study is to investigate the effect of theory-based educational intervention on behaviors of prenatal care in pregnant women referred to health centers in Iranshahr. This is an interventional and randomized study, carried out on 90 pregnant women referred to health centers in Iranshahr. Inclusion criteria were first pregnancy, wanted pregnancy, monogamy, aged between 18 and 35 years old, having health care records and gestational age less than 14 weeks; exclusion criteria included emigration, abortion, absence of the participants in the training sessions and require special care. Participants Were randomized in two groups. Four the intervention group, four sessions of 60 minutes was hold based on the theory (HBM and social support). Control group did not receive any intervention. Before the intervention, immediately after intervention, 3 and 6 months after the intervention, questionnaires were completed by the participants. The tool for collection of data was a questionnaire designed according to health belief model, social support, knowledge and behavior. The primary outcomes of the study include: to determine average scores of Structures of health belief model, social support and prenatal care and secondary outcomes included: to determine birth weight.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017030432876N1
Registration date: 2017-03-27, 1396/01/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-27, 1396/01/07
Registrant information
Name
Hossien Izadirad
Name of organization / entity
Tarbiat modares University, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3569
Email address
hossien.izadirad@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Tarbiat Modares University, Tehran, Iran
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2017-02-28, 1395/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of theory-based educational intervention on behaviors of prenatal care in pregnant women referred to health centers in Iranshahr
Public title
The effect of theory-based educational intervention on behaviors of prenatal care
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria were first pregnancy, wanted pregnancy, monogamy, aged between 18 and 35 years old, having health care records and gestational age less than 14 weeks; exclusion criteria included emigration, abortion, absence of the participants in the training sessions and require special care.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sample size was equal to 90 pregnant women that were selected based on simple random sampling and were assigned to intervention group (n=45) and control group (n=45) by the random number table.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
No 7, Jalal Al Ahmad Street, Tehran, Iran POST CODE 14115331
City
Tehran
Postal code
14115331
Approval date
2016-02-02, 1394/11/13
Ethics committee reference number
IR.TMU.REC.1394.224

Health conditions studied

1

Description of health condition studied
Prenatal care
ICD-10 code
Z34.0
ICD-10 code description
Supervision of normal first pregnancy

Primary outcomes

1

Description
Perceived Susceptibility
Timepoint
Before the intervention, immediately after intervention, 3 and 6 months after the intervention.
Method of measurement
Questionnaire Self-made

2

Description
Knowledge
Timepoint
Before the intervention, immediately after intervention, 3 and 6 months after the intervention.
Method of measurement
Questionnaire Self-made

3

Description
Perceived Severity
Timepoint
Before the intervention, immediately after intervention, 3 and 6 months after the intervention.
Method of measurement
Questionnaire Self-made

4

Description
Perceived Benefits
Timepoint
Before the intervention, immediately after intervention, 3 and 6 months after the intervention.
Method of measurement
Questionnaire Self-made

5

Description
Perceived Barriers
Timepoint
Before the intervention, immediately after intervention, 3 and 6 months after the intervention.
Method of measurement
Questionnaire Self-made

6

Description
Self-Efficacy
Timepoint
Before the intervention, immediately after intervention, 3 and 6 months after the intervention.
Method of measurement
Questionnaire Self-made

7

Description
Social support
Timepoint
Before the intervention, immediately after intervention, 3 and 6 months after the intervention.
Method of measurement
Questionnaire Self-made

8

Description
Prenatal care
Timepoint
Before the intervention, immediately after intervention, 3 and 6 months after the intervention.
Method of measurement
Questionnaire Self-made

Secondary outcomes

1

Description
Birth weight
Timepoint
After birth
Method of measurement
Scale

Intervention groups

1

Description
Intervention group of this study consisted of 45 pregnant women of Iranshahr city which four the intervention group, four sessions of 60 minutes was hold based on the theory (HBM and social support). Before the intervention, immediately after intervention, 3 and 6 months after the intervention, questionnaires were completed by the participants.
Category
Other

2

Description
Control group of this study consisted of 45 pregnant women of Iranshahr city. Control group did not receive any intervention. Simultaneously with the intervention group, Before the intervention, immediately after intervention, 3 and 6 months after the intervention, questionnaires were completed by the participants.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
health center 2
Full name of responsible person
Hossien Izadirad
Street address
No 8, Molavi Street, Iranshahr, Sistan & Baluchestan Province
City
Iranshahr

2

Recruitment center
Name of recruitment center
Health center (3)
Full name of responsible person
Hossien Izadirad
Street address
No 20, Moalem Blvd, Iranshahr, Sistan & Baluchestan Province
City
Iranshahr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Tarbiat Modares University
Full name of responsible person
Mansoreh Movahedin
Street address
No 7, Jalal Al Ahmad Street, Tehran, Iran
City
Ttehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Tarbiat Modares University
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
Tarbiat Modares University, Tehran, Iran.
Full name of responsible person
Hossien Izadirad
Position
Ph.D. student
Other areas of specialty/work
Street address
No 4, Royan Alley, Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
1415983341
Phone
+98 21 8801 3030
Fax
+98 21 8288 4555
Email
hossien.izadirad@modares.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University, Tehran
Full name of responsible person
Shamsoddin Niknami
Position
Associate Professor
Other areas of specialty/work
Street address
No 7, Jalal Al Ahmad Street, Tehran, Iran
City
Tehran
Postal code
14115331
Phone
+98 218011001
Fax
Email
niknamis@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University, Tehran
Full name of responsible person
Hossien Izadirad
Position
Ph.D. student
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
1415983341
Phone
00
Fax
Email
hossien.izadirad@modares.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
Loading...