Protocol summary

Summary
This randomized clinical trial study is on 90 primi-parous women referring to selected medical-educational centers (Arash & Baharloo hospitals ) in Tehtan University of Medical Sciences ,about The effect of Religious education on Religious knowledge and belief and Postpartum blues of the primipara women in Prenatal clinics in selected hospitals of Tehran University of Medical Sciences. This is a randomized clinical trial which was conducted on 220 pregnant women in the selected centers of Tehran university of medical science (Arash and Baharlo hospitals), for the purpose of investigating the effect of Religious education on the religion awareness and Postpartum. After obtaining of the patients' Consent, they were randomly divided into 2 groups of intervention and control. First religious attitudes and awareness and anxiety of the pregnant women were investigated and those who had high levels of religious attitudes were put aside; they only were investigated 7 to 10 days after Childbirth. Remaining people, who had average and low religious attitude were divided into 2 groups of intervention and control. In the intervention group they were under religious education and examined again, while in control group they just received normal care. Finally, the Postpartum were investigated and analyzed in 2 groups,0 and 1 and 3 months after the child birth for development.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013072714041N2
Registration date: 2013-11-01, 1392/08/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-11-01, 1392/08/10
Registrant information
Name
Tahereh Mokhtaryan Gilani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
mokhtar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences Dr. Gholamreza Hatam Shiraz - Zand Street - Next to the Red Crescent - Sakhtmtn Central University - Class 7 - Research Shiraz Fars Iran, Islamic Republic Of 00987112122633 vcrdep@sums.ac.ir
Expected recruitment start date
2013-10-07, 1392/07/15
Expected recruitment end date
2014-01-05, 1392/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Religious education Religious knowledge and belief on Indicators of infant growth 0 to 3 months in the primipara women in Prenatal in clinics in selected hospitals of Tehran University of Medical Sciences (2013)
Public title
The effect of Religious education Religious knowledge and belief on Indicators of infant growth 0 to 3 months in the primipara women in Prenatal in clinics in selected hospitals of Tehran University of Medical Sciences (2013)
Purpose
Prevention
Inclusion/Exclusion criteria
Criteria of inclusion in the study: Pregnant women in the age range of 18-45;Lack of chronic diseases (hearth problems, Lung disease, blood pressure, diabetes);The ability to participate in educational classes and filling up the Consent form;The mothers' level of anxiety must be classified as low or average according to Spil Beger scale. Criteria of exclusion from the study: Lack of interest in further contribution ; Illiteracy or lack of ability in filling up the questionnaires and speaking or writing in Farsi ; Any psychological disease diagnosis during the study (major depression, anxiety disorder) ; Appearance of pregnancy complications (Abruption, fetal death, preterm delivery, preeclampsia severe Aklamsy and so on ); Any unexpected events such as near relative death (husband, parents, child, …)
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
7 th floor- Research Assistance- Central University of Medical Sciences- Next to the Red Crescent- Zand Street
City
Shiraz
Postal code
71345-1978
Approval date
2013-01-10, 1391/10/21
Ethics committee reference number
5361-92 pct

Health conditions studied

1

Description of health condition studied
Failure to thrive
ICD-10 code
R62.8
ICD-10 code description
Other lack of expected normal physiological development

Primary outcomes

1

Description
Infant Growth and development
Timepoint
0 and 1 and 3 months after childbirth
Method of measurement
Denver Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
People in the intervention and control groups have average or low religious attitudes. Pregnant women were under religious education for 20 to 30 weeks, and after 6 sessions of education in each week(Deism Education), they again filled up the questionnaires on religious attitudes and awareness and anxiety, in this way it can be seen that the participation in these educational classes how much affected the religious attitudes and awareness and anxiety. 2 months after the education, 3 questionnaires would be again filled up in order to determine the stability of the education
Category
Prevention

2

Description
Characteristics of this group are characterized by the same group., But the second group received routine care (Control of Fetal Growth, Blood pressure, Weight and . . . ).
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash Hospital
Full name of responsible person
Mrs. Shokoohi
Street address
Baghdarnia St.frjam Ave.
City
Tehran

2

Recruitment center
Name of recruitment center
Baharloo Hospital
Full name of responsible person
Mr. Fath Abadi
Street address
Karegar Ave-Behdari St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
7 th floor- Research Assistance- Central University of Medical Sciences- Next to the Red Crescent- Zand Street
City
shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
Master of Midwifery
Other areas of specialty/work
Street address
Namazi Square- University of Nursing and Midwifery
City
Shiraz
Postal code
Phone
+98 71 1647 4254
Fax
Email
akbarzadehmarzieh@yahoo.com
Web page address
www.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
Master of Midwifery
Other areas of specialty/work
Street address
Namazi Square- University of Nursing and Midwifery
City
Shiraz
Postal code
Phone
00897116474254
Fax
Email
akbarzadehmarzieh@yahoo.com
Web page address
www.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Tahereh Mokhtaryan Gilani
Position
Master of Midwifery
Other areas of specialty/work
Street address
Namazi Square- University of Nursing and Midwifery
City
Shiraz
Postal code
Phone
+98 21 2293 1333
Fax
+98 21 8853 6775
Email
mokhtar@sums.ac.ir
Web page address
www.sums.ac.ir

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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