Purpose: The Effect of Educational-religious Intervention on pregnant women referred to Baqiyatallah Medical Sciences' hospitals in 2014. 2. Comparing the mean scores of stress, anxiety and depression before the intervention in two experimental and control groups. Method: In this study, a randomized clinical trial with allocation to experimental and control groups with convenience sampling method, 84 pregnant women participated in two clinics. Four training sessions for mothers were done within two weeks. All participants demographic questionnaire, DASS42 and religious index at Duke University in the pre-test session (first trimester) were completed and then test 1 and Track 2 at weeks 20 and 32 was conducted after the training sessions. Intervention: first session; initial assessment, knowledge and research objectives, pre-test, the definition of pregnancy and Anatomic and physiologic changes and stressors during pregnancy and define religiously important pregnancy. Session II: Introduction to pregnancy stress and its effects on the mother and fetus. Third session: religious education recommended in this period and the ways to achieve relaxation religious. Fourth session: the review conference.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080923565N1
Registration date:2015-09-15, 1394/06/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-15, 1394/06/24
Registrant information
Name
Zarindokht Sheikholia
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 9979
Email address
z-olia@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences, Vice Chancellor for research .
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational-religious intervention on pregnantwomen referred to Baqiyatallah medical science hospitals in 2014-2015
Public title
The effect of religious educational intervention on stress, anxiety and depression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the pregnant woman with singleton pregnancies in the first trimester pregnancy; low-risk pregnancy; lack of mental health problems in the past; not applying specific drug or medications; no history of mental disorder; adequate literacy; signing informed consent in research; participate in all training sessions.
Exclusion criteria: the incidence of pregnancy complications, including bleeding, diabetes, hypertension, internal medicine; having sever trauma and stress; unwillingness to participate in research.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
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
Ethics Committee Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Sheikh Bahai St., Hemmat highway
City
Tehran
Postal code
Approval date
2014-11-15, 1393/08/24
Ethics committee reference number
5904
Health conditions studied
1
Description of health condition studied
Stress in pregnancy
ICD-10 code
O20-29
ICD-10 code description
Other maternal disorders predominantly related to pregnancy
Primary outcomes
1
Description
Anexiety
Timepoint
Before the intervention, one and three months after intervention
Method of measurement
Stress, anxiety and depression questionnaire DASS42
2
Description
Stress,
Timepoint
Before the intervention, one and three months after intervention
Method of measurement
A standard questionnaire on stress, anxiety and depression DASS42
3
Description
Depression
Timepoint
Before the intervention, one and three months after intervention
Method of measurement
Stress, anxiety and depression questionnaire DASS4
Secondary outcomes
1
Description
Infant anthropometric factors, including weight, height, head circumference and chest circumference newborn baby
Timepoint
At birth time
Method of measurement
Physical examination
2
Description
Delivery time
Timepoint
Delivery times below 38 weeks and after 38 weeks
Method of measurement
Medical records
Intervention groups
1
Description
In intervention group: Educating mothers on the basis of religious orders and methods of religious plan in 4 sessions of the first quarter every two weeks for 60 minutes per session through group discussions, questions and answers, with educational manual and pamphlets.
Category
Prevention
2
Description
No intervention in control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah hospital's gynecology clinic
Full name of responsible person
Zarindokht Sheikholia, Master's degree in health education and health promotion.
Street address
Sheykh Bahaee St., Hemmat highway
City
Tehran
2
Recruitment center
Name of recruitment center
Najmieh hospital gynecology clinic
Full name of responsible person
Zarindokht Sheikholia, Master's degree in health education and health promotion.
Street address
Jomhoori street - Hafez crossroad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Morteza Izadi
Street address
Baqiyatallah University of Medical Sciences, Sheikh Bahai St., Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah 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
School of Public Health, Baqiyatallah University of Medical Sciences
Full name of responsible person
Zarindokht Sheikholia
Position
Msc health education
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Sheikh Bahai St., Hemmat highway
City
Tehran
Postal code
Phone
Fax
Email
z-olia@bmsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Public Health, Baqiyatallah University of Medical Sciences
Full name of responsible person
Hormoz Sanaee Nasab
Position
Associate professor of health education and health promotion
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Sheikh Bahai St., Hemmat highway
City
Tehran
Postal code
Phone
+98 21 8248 2000
Fax
Email
sanain@yahoo.co.in
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Public Health, Baqiyatallah University of Medical Sciences
Full name of responsible person
Zarindokht Sheikholia
Position
Msc in health education
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Sheikh Bahai St., Hemmat highway
City
Tehran
Postal code
Phone
Fax
Email
zarin.olia@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)