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Effect of cognitive- behavioral educations on childbirth self-efficacy and maternal role adaptation and fear of childbirth in nulliparous women

Protocol summary

Study aim
Effect of cognitive- behavioral educations on childbirth self-efficacy and maternal role adaptation and fear of childbirth in nulliparous women
Design
Semi experimental study with control group, with two parallel groups design of 70 patients
Settings and conduct
This study will be performed in the prenatal clinic of the Milad hospital. During the weeks 26 to 28 of pregnancy, completed the ​demographic questionnaire, general health questionnaire, Wijma Delivery Expectancy/ Experience Questionnaire Version A and Child Birth Self-Efficacy Inventory will be collected by the participants from the two groups of intervention and control. Then, the training classes will be started from 28th weeks of pregnancy during 8 sessions of 90 minutes and once a week that their contents are equal to cognitive- behavioral training. In each session, the homework of the previous sessions will be checked and also the specific practice will be given for the next session. at the last cognitive and behavioral training sessions, the questionnaire of fear of delivery and self-efficacy will be completed by the two different groups. In addition, two and eight weeks after delivery, the Maternal Role Adaptation Questionnaire and the Wijma Delivery Expectancy/ Experience Questionnaire Version B will be completed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-35 years old, Diploma and higher education, Single pregnancy, Nullipara, 28-26 week of gestational age, Scoring 65 and above Fear of Childbirth, Scoring 3 / 5 and less general health questionnaire, No history of infertility
Intervention groups
1ٰ.In the cognitive-behavioral education, the classes are conducted from 28 to 35 weeks of gestation during 8 sessions of 90 minutes weekly. 2. In the control group, the sample does not receive any intervention​.
Main outcome variables
maternal role adaptation, self-efficacy, Fear of childbirth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180427039436N3
Registration date: 2018-12-31, 1397/10/10
Registration timing: registered_while_recruiting

Last update: 2018-12-31, 1397/10/10
Update count: 0
Registration date
2018-12-31, 1397/10/10
Registrant information
Name
Leila Amiri Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1139
Email address
l.amirifarahani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cognitive- behavioral educations on childbirth self-efficacy and maternal role adaptation and fear of childbirth in nulliparous women
Public title
Effect of cognitive- behavioral educations in nulliparous women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
18-35 years old Diploma and higher education Single pregnancy Nullipara 28-26 week of gestational age Scoring 65 and above in Fear of Childbirth Scoring 3 / 5 and less in general health questionnaire No history of infertility
Exclusion criteria:
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: 70
Randomization (investigator's opinion)
Not 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 of Iran University of Medical Sciences
Street address
Hemat highway next to milad tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-08-26, 1397/06/04
Ethics committee reference number
IR.IUMS.REC.1397.346

Health conditions studied

1

Description of health condition studied
cognitive- behavioral education
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Maternal role adaptation
Timepoint
2 weeks and 2 months after childbirth
Method of measurement
Maternal role adaptation questionnaire

2

Description
Fear of childbirth
Timepoint
Before intervention at 26-28 week gestation, before and immediately after intervention and 2 weeks and 2 months after childbirth
Method of measurement
Delivery expectancy/ experience questionnaire version A, Fear of childbirth questionnaire version B

3

Description
Childbirth self-efficacy
Timepoint
Before intervention at 26-28 week gestation, before and immediately after intervention
Method of measurement
Child birth self-efficacy inventory questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group (cognitive-behavioral educations and childbirth preparation classes in two distinct classes), the beginning of cognitive-behavioral educations classes, is conducted from 28 to 35 weeks of gestation during 8 sessions of 90 minutes, including: session 1: the importance of classes cognitive and behavioral, emotional disturbances, awareness of fear of childbirth and How to encounter, session 2: familiarity with cognitive- behavioral educations, session 3: familiarity with cognitive distortions and empowering individuals, session 4: solution for an issue, , session 5: training to remember, session 6: familiarity with the concept of childbirth self-efficacy and maternal role adaptation, session 7: definition, principles and action of self-acceptance in person, session 8: an review of past sessions, plans for changing mind and behavior in the future, encouraging to continue exercises, giving feedback and saying goodbye.
Category
Other

2

Description
Control group: Control (taking part in childbirth classes) does not receive any intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Milad hospital
Full name of responsible person
Fatemeh Eidozaei
Street address
Milad Hospital, Hemmat Highway, District 2 of Tehran
City
Tehran
Province
Tehran
Postal code
1449614531
Phone
+98 21 84090
Fax
+98 21 8806 2005
Email
info@miladhospital.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malekoty
Street address
Hemat highway next to milad tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6650 9024
Fax
+98 21 8805 2248
Email
malakoutik@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Eidozaei
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Rashid yasemi street, above vanak square, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
feidi2727@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Eidozaei
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Rashid yasemi street, above vanak square, Valiasr Ave
City
tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
feidi2727@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Rashid yasemi street, above vanak square, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 4365 1139
Email
l.amirifarahani@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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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