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Effectiveness of REPLAN training on the fear of childbirth and self-efficacy of pregnant women with natural childbirth anxiety

Protocol summary

Study aim
ترجمه نوشتار با دوربین effectiveness of this treatment model on fear of childbirth and self-efficacy in women with natural childbirth anxity
Design
All pregnant women referred to the health centers of Sari city in 1402-03, which were purposefully selected from among the selected areas of 3 health centers. Natural childbirth anxiety scale implemented on pregnant women. After scoring the questionnaires, 32 people were selected and placed in two experimental groups and one control group by random replacement method. 30 women who met the criteria for entering the research were identified and randomly assigned to the experimental group and the control group, 15 people in each group.
Settings and conduct
Replan was implemented in 8 sessions of 90 minutes in a private practice in two months
Participants/Inclusion and exclusion criteria
having anxiety about childbirth, no illness or problem threatening the health of the mother and fetus (such as severe heart disease, chronic hypertension, cervical insufficiency, diabetes or gestational diabetes), willingness to participate in the study, being literate in reading and writing. First pregnancy, age range 18-38, desired pregnancy between 20 and 37 weeks, no psychiatric disorders before or during the research that led to the use of psychiatric drugs (stated by patient and medical record).
Intervention groups
ترجمه نوشتار با دوربینIn this design, a semi-experimental method of pre-test and post-test with control group was used. After randomly replacing the subjects into the experimental group and the control group, the pre-test was done, then one of the groups was taught the Replan plan, and the control group did not receive any kind of educational intervention. It was tested. This study include
Main outcome variables
Reducing anxiety and fear of childbirth and increasing self-efficacy of pregnant women with childbirth anxiety

General information

Reason for update
Acronym
REPLAN
IRCT registration information
IRCT registration number: IRCT20240721062492N1
Registration date: 2024-08-22, 1403/06/01
Registration timing: retrospective

Last update: 2024-08-22, 1403/06/01
Update count: 0
Registration date
2024-08-22, 1403/06/01
Registrant information
Name
Omolbanin Masihpour Mojavery
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3330 2091
Email address
fmasihpour19@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
2023-05-22, 1402/03/01
Actual recruitment end date
2023-08-23, 1402/06/01
Trial completion date
2023-08-23, 1402/06/01
Scientific title
Effectiveness of REPLAN training on the fear of childbirth and self-efficacy of pregnant women with natural childbirth anxiety
Public title
Effectiveness of REPLAN training on the fear of childbirth and self-efficacy of pregnant women with natural childbirth anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
having childbirth anxiety willingness to participate in studies having literacy first pregnancy age range 18-38 desired pregnancy and between 20 and 37 weeks of pregnancy
Exclusion criteria:
A disease or problem threatening the health of the mother and fetus (such as severe heart ) chronic hypertension cervical insufficiency diabetes or gestational diabetes no history of heart attack or stroke no psychiatric disorders before or during the research that lead tohad taken psychiatric drugs (stated by the patient and medical record)
Age
From 18 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
To the first 15 people with pregnancy anxiety (counting device) 1 to 15 first people, if they meet the conditions for entering the study, are included in the intervention group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University, Tunkabon branch
Street address
: Mazandaran-Tankabon-Km 3 of Chalus Road-Waliabad-Tankabon Islamic Azad University Complex
City
Sari
Province
Mazandaran
Postal code
۴۶۸۴۱۶۱۱۶۷
Approval date
2023-08-24, 1402/06/02
Ethics committee reference number
IR.IAU.TON.REC.1402.062

Health conditions studied

1

Description of health condition studied
Natural childbirth anxiety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fear of childbirth and self-efficacy of pregnant women, fear of childbirth was measured by Weij questionnaire and self-efficacy was measured by Louis questionnaire.
Timepoint
Fear of childbirth and self-efficacy were measured at the beginning of the study before Riplan training and then after training
Method of measurement
Vijma fear of childbirth questionnaire, Louis self-efficacy questionnaire and childbirth anxiety by Vandenberg questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: The intervention group consisted of 15 pregnant women who were randomly selected with natural childbirth anxiety and underwent 8 sessions of 90-minute Replan training,.Session one pre-test performance, introducing and familiarizing the members with each other, stating the rules and regulations of the group, determining the goals and expectations of the group, establishing a relationship based on cooperation, asking the therapeutic expectations of each participant, session two establishing a relationship between the counselor and the participants, shaping therapeutic alliance, discovering the underlying factors of the problem of each participant, session three, explaining about self-esteem and its difference with self-confidence, the importance of self-esteem in life, session four, regulation of emotions, positive and negative emotions, empathy training, session five, problem solving training, training and identification Cognitive distortions, session six, stating the relationship between emotion, feeling and behavior, session seven, motivation and ways to increase it and using behavioral activation, session eight, examining the effectiveness of learned techniques, identifying implementation obstacles, providing appropriate and useful solutions to remove obstacles , post-test implementation.
Category
Behavior

2

Description
Control group: Control group: The control group had pregnancy anxiety, no training and treatment was done and only pregnancy control was done
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sari health centers
Full name of responsible person
Omolbanin Masihpour Mojavery
Street address
Farhang Street, Hafez Street, Hafeziya Apartment No. 7
City
Sari
Province
Mazandaran
Postal code
4818846676
Phone
+98 935 128 2605
Email
fmasihpour19@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samia Asadian
Street address
Mazandaran-Tankaben-km 3 of Chalus road-Waliabad-Tankaben Islamic Azad University complex
City
Tonokabon
Province
Mazandaran
Postal code
۴۶۸۴۱۶۱۱۶۷
Phone
+98 11 5427 1108
Email
Assadiannarenjisomayeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Omolbanin Masihpour Mojavery
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Farhang Ave ,Haf St Applertman Haftiye No. 7
City
Sari
Province
Mazandaran
Postal code
4818846676
Phone
+98 11 3320 8042
Email
fmasihpour19@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Omolbanin Masihpour Mojavery
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Av Farhang ,St Haft Applertman Haftiye No. 7
City
Sari
Province
Mazandaran
Postal code
4818846676
Phone
+98 11 3320 8042
Email
fmasihpour19@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Omolbanin Masihpour Mojavery
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No.7,Hafezieh Apr,Hafez Ave,Farhang Ste,Sari Town
City
Sari
Province
Mazandaran
Postal code
4818846676
Phone
+98 11 3320 8042
Email
fmasihpour19@gmail.com

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The The effectiveness of Riplan training on fear of childbirth and self-efficacy of pregnant women with natural childbirth anxiety
When the data will become available and for how long
The study has been a training class since the beginning of June 1402 for 8 weeksAnd it is accessible immediately after printing.
To whom data/document is available
All people who suffer from pregnancy anxiety and the right people can be reached in this matter
Under which criteria data/document could be used
The data is available in pdf and word format through the article and email address of the main author
From where data/document is obtainable
Babol Journal of Medical Sciences The main author is Umm al-Binin Masihpour Mojaari Tonkabon University The author's email is fmasihpour19@gmail.com
What processes are involved for a request to access data/document
Application process by email for one day SMS 09351282605 immediately
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