Evaluation of online prenatal education's effect on fear of child birth in primigravida women, Gorgan 2021
Design
randomized Clinical trial with with control group, parallel groups, community-based and pragmatic, one-blind
Settings and conduct
This study will be conducted in health centers in Gorgan City. pregnant women will be Randomized into two groups. In this study, because the researcher himself randomizes the samples and intervenes, she cannot be blind. However, the participants are not aware of their position in the control and intervention group, so the study is one-sided blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
primigravid women, low-risk pregnancies and gestational age 20-24 weeks، willingness to participate in the study
exclusion criteria:
History of mental or anxiety disorder, use of any sedatives or medications related to anxiety disorders, infertility history, need for intensive care during pregnancy, drug addiction
Intervention groups
intervention group: This group will receive online pregnancy training in accordance with the wijma Fear of childbirth Package.
control group: This group will receive online pregnancy training in accordance of ministry of health protocol Package.
Main outcome variables
Fear of child birth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180408039229N3
Registration date:2021-06-17, 1400/03/27
Registration timing:registered_while_recruiting
Last update:2021-06-17, 1400/03/27
Update count:0
Registration date
2021-06-17, 1400/03/27
Registrant information
Name
Narjes Sadat Borghei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 9718
Email address
dr.borghei@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-12, 1400/03/22
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of online prenatal education's effect on fear of child birth in primigravid women
Public title
Evaluation of online prenatal education's effect on fear of child birth in pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
primigravid women
low-risk pregnancy
gestational age between 20-24 weeks
willingness to participate in the study
Exclusion criteria:
History of mental or anxiety disorder
use of any sedatives or medications related to anxiety disorders
infertility history
need for intensive care during pregnancy
drug addiction
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:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method: block Randomization
Random unit: Individual
For random assignment of samples to the intervention and control groups, the quadratic block method with permutations (AABB-ABAB-ABBA-BABA-BAAB-BBAA) will be used. A represents the intervention group and B represents the control group. The blocks are randomly selected without placement and the samples will be assigned to groups according to their permutations.
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 of Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, Hyrcan Boulevard, beginning of Shisht Kola Road, Deputy of Research and Technology., Gorgan
Intervention group: This group will receive pregnancy training in accordance with the Wijma Delivery Expectancy/Experience Questionnaire Fear Package.These trainings will be done in eight sessions of 40 minutes, weekly and online.
Category
Behavior
2
Description
Control group: This group will receive pregnancy training in according to the protocol of the Ministry of Health as prenatal education Package.These trainings will be done in eight sessions of 40 minutes, weekly and online.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Gorgan Health Centers
Full name of responsible person
Elnaz pooralijani
Street address
Gorgan's Health Center., Razi St., Gorgan
City
Gorgan
Province
Golestan
Postal code
4914819971
Phone
+98 17 3329 7550
Email
puralijanielnaz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Honarvar
Street address
Golestan University of Medical Sciences, Hyrcan Boulevard, beginning of Shisht Kola Road, Deputy of Research and Technology., Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 1660
Email
info@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Elnaz pooralijani
Position
Master's student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan University of Medical Sciences, Hyrcan Boulevard, beginning of Shisht Kola Road, Nursing and Midwifery school., Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 6900
Email
puralijanielnaz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narjes sadat borghei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Golestan University of Medical Sciences, Hyrcan Boulevard, beginning of Shisht Kola Road, Nursing and Midwifery School., Gorgan
City
Gorgan
Province
Golestan
Postal code
4913815739
Phone
+98 17 3245 6900
Email
borghei2006@ yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Elnaz pooralijani
Position
Master's student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan University of Medical Sciences, Hyrcan Boulevard, beginning of Shisht Kola Road, Nursing and Midwifery School., Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 6900
Email
puralijanielnaz@gmail.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
No decision has been made yet
When the data will become available and for how long
Six months after the article was published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
the part of Data for similar research can be used scientifically and with reference. To access the data, they can send a message to the email address of Correspondent Author.
From where data/document is obtainable
Correspondent Author
What processes are involved for a request to access data/document
Applicants can send a message to the correspondent's email and finally receive a response within a week.