Investigating the effect of stress management educational intervention on the fear of natural childbirth and the choice of the type of delivery based health belief model of primiparous women
Determining the effect of stress management training intervention on fear of natural childbirth and choice of delivery type in primiparous women of Dashtestan city
Design
Clinical trial with control group, with parallel groups, single blind, randomized, phase 3 on 126 patients. Cluster type randomization and random numbers extracted from the computer were used.
Settings and conduct
The study is conducted on the day of pregnant women referring to health centers. Its purpose was to investigate the effect of stress management educational intervention on the fear of childbirth and the choice of natural childbirth among primiparous women in Dashtestan city. The study was one-sided blind and the participants did not know about their assignment to the training and control groups.
Participants/Inclusion and exclusion criteria
Conditions for entering the study sample
Minimum reading and writing literacy, age 18 to 40, no history of childbirth, pregnancy age 16 to 28 weeks, mother not suffering from mental illness, ability to participate in educational classes and complete the informed consent form
Conditions for sample withdrawal from the study: unwillingness to participate in the study or termination of cooperation, termination of pregnancy for any reason, withdrawal from participation in the study, moving to another city
Intervention groups
Participants in the intervention group receive training during 8 sessions.
Main outcome variables
choice of natural childbirth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111017007816N23
Registration date:2024-06-14, 1403/03/25
Registration timing:registered_while_recruiting
Last update:2024-06-14, 1403/03/25
Update count:0
Registration date
2024-06-14, 1403/03/25
Registrant information
Name
Mahin Nazari
Name of organization / entity
School of health
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
manazari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of stress management educational intervention on the fear of natural childbirth and the choice of the type of delivery based health belief model of primiparous women
Public title
effect of education on the stress of fear of childbirth and the choice of natural childbirth
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum literacy
Being 18 to 40 years old
Primiparous pregnant women
Pregnant women who are in the 16th to 28th week of pregnancy
Ability to attend classes regularly
Completion of written consent
Exclusion criteria:
Mother suffering from mental illnesses (through the study of the record during pregnancy)
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization
Random unit: cluster
Random tool: computer-assisted random numbers
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 Shiraz University of Medical Sciences
Street address
Razi Blvd., in front of the Electrical Club of the Faculty of Health
City
Shiraz
Province
Fars
Postal code
7153675541
Approval date
2024-02-03, 1402/11/14
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1402.146
Health conditions studied
1
Description of health condition studied
Stress and fear of natural childbirth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reducing stress and fear of natural birth and choosing natural birth
Timepoint
Assessing the constructs of the health belief model, fear of childbirth and stress, at the beginning of the study (before the beginning of the educational intervention) and 3 months after the educational intervention, Measuring demographic information at the beginning of the study.
Method of measurement
Assessing the constructs of the health belief model: Mohagheg Zagh questionnaire, Wijma childbirth fear questionnaire, Cohen's stress questionnaire, demographic information questionnaire
Secondary outcomes
1
Description
Reducing the stress score and fear of childbirth
Timepoint
Before the educational intervention
Method of measurement
3 months after the educational intervention
2
Description
Increased self-efficacy score was perceived
Timepoint
Before the intervention and 3 months after the educational intervention
Method of measurement
The questionnaire was developed by the researcher
3
Description
Reducing the score of intensity, sensitivity and perceived obstacles
Timepoint
Before the intervention and 3 months after the educational intervention
Method of measurement
The questionnaire was developed by the researcher
Intervention groups
1
Description
Intervention group:
Category
Behavior
2
Description
Control group:
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health centers covered by health and treatment network of Dashtestan city
Full name of responsible person
Maria is self-righteous
Street address
Borazjan, Imam Khomeini Square, Dashtestan Health Network
City
Dashtestan
Province
Boushehr
Postal code
۷۵۶۱۷۹۹۷۱۶
Phone
+98 77 3422 7321
Email
dehghanazita54@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahin Nazari
Street address
Razi Blvd., in front of the Electrical Club of the Faculty of Health
City
shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
schealth@sums.ac.ir
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Mahin Nazari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Shiraz - Razi Blvd. in front of the electricity club of the Faculty of Health and Nutrition
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
mnazari@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahin Nazari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Shiraz - Razi Blvd. in front of the electricity club of the Faculty of Health and Nutrition
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
mnazari@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
mahin nazari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Shiraz - Razi Blvd. in front of the electricity club of the Faculty of Health and Nutrition
City
shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
mnazari@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
All the people of the society to the magazine in which the article was published
Under which criteria data/document could be used
Supervisor
From where data/document is obtainable
Dr. Mahin Nazari email- manazari@sums.ac.ir
What processes are involved for a request to access data/document
It takes about a week to a month from the responsible author to the coordinator