Protocol summary

Study aim
Establishing the Impact of Response Group counseling on the self - efficacy in primiparous women Establishing the Impact of Response Group counseling on the Fear of childbirthin primiparous women
Design
Randomized Clinical trials with control groups, based on Participants in preparation classes for childbirth and solution - Focused Group counseling .
Settings and conduct
centers for providing physiological delivery services in Yazd، The Intervention group will participate in preparation classes for delivery and solution - Focused counseling & The control group just participates in preparation classes for childbirth
Participants/Inclusion and exclusion criteria
Age range between 18 and 35 years،Gestational age at least 20 weeks and a maximum of 28 weeks،First Pregnancy & Singleton Pregnancy،Having read and write literacy،Tendency to Participate in Antenatal Preparation Classes.Multipara Addiction Use of psychiatric drugs in The last six months Big stress in The last six months Such as Death of kin Early medical conditions(Diabetes .Chronic hypertension history.
Intervention groups
The Intervention group will participate in preparation classes for delivery and solution - Focused counseling & The control group just participates in preparation classes for childbirth.
Main outcome variables
Childbirth self - efficacy، Fear of childbirth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190203042607N1
Registration date: 2019-04-18, 1398/01/29
Registration timing: prospective

Last update: 2019-04-18, 1398/01/29
Update count: 0
Registration date
2019-04-18, 1398/01/29
Registrant information
Name
Najme Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3334 9412
Email address
n.heidari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-08, 1398/02/18
Expected recruitment end date
2019-08-09, 1398/05/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
"The Effectiveness Of Solution-focused Group Counseling on Fear of Childbirth&Selfefficacy in Nulliparous Women"
Public title
"The Effect Of Solution-focused Group Counseling on Fear of Childbirth & Selfefficacy"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range between 18 and 35 years First pregnancy Gestational age at least 20 weeks and a maximum of 28 weeks Singleton Pregnancy Having read and write literacy Tendency to Participate in Antenatal Preparation Classess
Exclusion criteria:
Multipara Addiction Use of psychiatric drugs in The last six months Big stress in The last six months Such as Death of kin Early medical conditions(Diabetes.Chronic hypertension history&..)
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: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomized Two State-run who had the highest statistics for pregnant women was chosen as a statistical society And then by chance, by drawing the lottery, One center was selected as the test group and a center as control group.
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 Yazd University of Medical Sciences
Street address
Imam Reza Educational Center،Student Blvd، Imam hosein Squ
City
Yazd
Province
Yazd
Postal code
8916998949/638
Approval date
2018-11-13, 1397/08/22
Ethics committee reference number
IR.SSU.REC.1397.096

2

Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Imam Reza Educational Center،Student Blvd، Imam hosein Squ
City
Yazd
Province
Yazd
Postal code
8916998949/638
Approval date
2018-11-13, 1397/08/22
Ethics committee reference number
IR.SSU.REC.1397.096

Health conditions studied

1

Description of health condition studied
Childbirth Self-efficacy
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Fear of Child Birth
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Efficacy Score according to Loe Child Birth self - efficacy questionnaire
Timepoint
Before intervention, immediately after the intervention was over and two weeks after the intervention ended
Method of measurement
Loe Child Birth self - efficacy questionnaire

2

Description
Fear of Child Birth
Timepoint
Before intervention, immediately after the intervention was over and two weeks after the intervention ended
Method of measurement
Wijma Fear of Child Birth questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The Intervention groupwill Participate in preparation Classes for childbirth and Participants in Solution Focused Group Counseling Classes
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Kargar Hospital
Full name of responsible person
Khoshbin Azam
Street address
Namaz Squ، Modarres Blv
City
Yazd
Province
Yazd
Postal code
1457965595
Phone
+98 35 3182 2000
Fax
+98 35 3825 0007
Email
www.info@tamin.ir

2

Recruitment center
Name of recruitment center
Imam Ali specialized clinic
Full name of responsible person
Khoshbin Azam
Street address
Navvab St، Madar Squ
City
Yazd
Province
Yazd
Postal code
8916998338
Phone
+98 35 3224 1900
Fax
+98 35 3225 3749
Email
www.tarabzade2594@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Khoshbin Azam
Street address
Central headquarters of the University،Bahonar Squ
City
Yazd
Province
Yazd
Postal code
8916998338
Phone
+98 35 3724 0171
Fax
+98 35 3724 0175
Email
www.info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Khoshbin Azam
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
College of Nursing & Midwifery، Boali Lane ،Timsar Falahi St، Safaeiye
City
Yazd
Province
Yazd
Postal code
8916998338
Phone
+98 35 3824 1751
Fax
+98 35 3824 9705
Email
azamkhoshbin@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Khoshbin Azam
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
College of Nursing & Midwifery،Boali Lane،Timsar Falahi St،Safaeiye
City
Yazd
Province
Yazd
Postal code
8916998338
Phone
+98 35 3824 1753
Fax
+98 35 3824 1751
Email
azamkhoshbin@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Najme
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Imam Reza Educational Center،Student Blv،Imam Hosein Squ
City
Yazd
Province
Yazd
Postal code
8916998949
Phone
+98 35 3623 4112
Fax
+98 35 3623 4114
Email
nheidari1373dsh@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The Whole data is Available After identifying individuals such as: Birth Type، Fear score، Self-Efficacy score، level of education، Income rate،Employment status
When the data will become available and for how long
6 months after the results were published.
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
The data are available only to rely on the future papers of individuals.
From where data/document is obtainable
Email: nheidari1373dsh@gmail.com Mobile number:09139687304
What processes are involved for a request to access data/document
A maximum of a week after your email is sent or the phone call is called.
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