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Protocol summary
Determine the effect of education on fear of of Childbirth in Nulliparous Women
Determine the effect of group training based on cognitive-behavioral techniques on fear of of Childbirth in Nulliparous Women
Determine the effect of educationgroup training based on cognitive-behavioral techniques on fear of of Childbirth in Nulliparous Women
تعیین تاثیر آموزش بر ترس از زایمان مادران باردار نخست زا
تعیین تاثیر آموزش¬های گروهی مبتنی بر فنون شناختی-رفتاری بر ترس از زایمان مادران باردار نخست زا
تعیین تاثیر آموزش¬های گروهی مبتنی بر فنون شناختی-رفتاری بر ترس از زایمان مادران باردار نخست زا
Randomized field trial with one control group and two parallel intervention groups.
Field trial with one control group and two parallel intervention groups
Randomized fieldField trial with one control group and two parallel intervention groups.
کارآزمایی میدانی دارای یک گروه کنترل و دو گروه مداخله موازی.
کارآزمایی میدانی دارای یک گروه کنترل و دو گروه مداخله موازی
کارآزمایی میدانی دارای یک گروه کنترل و دو گروه مداخله موازی.
This study will be done at health centers in Gorgan city. Nulliparous mothers with a score of fear of moderate to high birth will be divided into three groups. The first intervention group will pass eight sessions of pregnancy training class and the second intervention group will pass eight sessions of cognitive behavioral therapy education, and control groups are people who do not Participation receive any training.
This study will be done at health centers in Gorgan city. Nulliparous mothers with a score of fear of moderate to high birth will be divided into three groups. The first intervention group will pass eight sessions of pregnancy training class and the second intervention group will pass eight sessions of cognitive behavioral therapy education, and control groups are people who do not Participation receive any training.
This study will be done at health centers in Gorgan city. Nulliparous mothers with a score of fear of moderate to high birth will be divided into three groups. The first intervention group will pass eight sessions of pregnancy training class and the second intervention group will pass eight sessions of cognitive behavioral therapy education, and control groups are people who do not Participation receive any training.
General information
104
108
104108
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2018-05-15, 1397/02/25
2018-05-15 00:00:00
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Change in date and number of realized sampling and randomization (random assignment was not done due to ethical consideration and assigned two groups based on Personal desire)
Change in date and number of realized sampling and randomization (random assignment was not done due to ethical consideration and assigned two groups based on Personal desire)
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تغییر در تاریخ نمونه گیری محقق یافته و تعداد نمونه ها و تصادفی سازی (عدم تخصیص تصادفی به علت ملاحظات اخلاقی)
تغییر در تاریخ نمونه گیری محقق یافته و تعداد نمونه ها و تصادفی سازی (عدم تخصیص تصادفی به علت ملاحظات اخلاقی)
ٍEvaluation of The effect of antenatal education on fear of childbirth in nulliparous women
ٍThe Effect of group educations based on Cognitive-Behavioral Techniques on fear of childbirth in primiparous mothers
ٍEvaluationThe Effect of The effect of antenatal educationgroup educations based on Cognitive-Behavioral Techniques on fear of childbirth in nulliparous womenprimiparous mothers
بررسی تاثیر آموزش های دوران بارداری بر ترس از زایمان مادران باردار نخست زا
بررسی تاثیر آموزش¬های گروهی مبتنی بر فنون شناختی-رفتاری بر ترس از زایمان مادران باردار نخست¬زا
بررسی تاثیر آموزش¬های دوران بارداریگروهی مبتنی بر فنون شناختی-رفتاری بر ترس از زایمان مادران باردار نخست¬زا
ٍEvaluation of The effect of education on Fear of childbirth in nulliparous women
The Effect of group educations based on Cognitive-Behavioral Techniques on fear of childbirth in primiparous mothers,
ٍEvaluationThe Effect of The effect of educationgroup educations based on FearCognitive-Behavioral Techniques on fear of childbirth in nulliparous womenprimiparous mothers,
بررسی تاثیر آموزش های دوران بارداری بر ترس از زایمان مادران باردار نخست زا
بررسی تاثیر آموزش¬های گروهی مبتنی بر فنون شناختی-رفتاری بر ترس از زایمان مادران باردار نخست زا
بررسی تاثیر آموزش¬های دوران بارداریگروهی مبتنی بر فنون شناختی-رفتاری بر ترس از زایمان مادران باردار نخست زا
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empty
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Health conditions studied
#1
The effect of education on fear of childbirth in nulliparos mothers
The effect of group educations based on Cognitive-Behavioral Techniques on fear of childbirth in primiparous mothers
The effect of educationgroup educations based on Cognitive-Behavioral Techniques on fear of childbirth in nulliparosprimiparous mothers
تاثیر آموزش بر ترس از زایمان مادران باردار نخست زا
تاثیر آموزش¬های گروهی مبتنی بر فنون شناختی-رفتاری بر ترس از زایمان مادران باردار نخست زا
تاثیر آموزش¬های گروهی مبتنی بر فنون شناختی-رفتاری بر ترس از زایمان مادران باردار نخست زا
Protocol summary
Study aim
Determine the effect of group training based on cognitive-behavioral techniques on fear of of Childbirth in Nulliparous Women
Design
Field trial with one control group and two parallel intervention groups
Settings and conduct
This study will be done at health centers in Gorgan city. Nulliparous mothers with a score of fear of moderate to high birth will be divided into three groups. The first intervention group will pass eight sessions of pregnancy training class and the second intervention group will pass eight sessions of cognitive behavioral therapy education, and control groups are people who do not Participation receive any training.
Participants/Inclusion and exclusion criteria
Nulliparous Women aged 18 to 35 years old؛ Gestational age 20 to 28 Week؛ The desire to participate in the study؛ Medium fear of birth score (55 and more)
Intervention groups
The first intervention group will pass the traditional pregnancy training programs. The second intervention group, will pass eight sessions of 90 minute weekly cognitive behavioral therapy. The third groups don't have any educational sessions.
Main outcome variables
fear of Childbirth
General information
Reason for update
Change in date and number of realized sampling and randomization (random assignment was not done due to ethical consideration and assigned two groups based on Personal desire)
Acronym
IRCT registration information
IRCT registration number:IRCT20171026037015N3
Registration date:2018-06-16, 1397/03/26
Registration timing:retrospective
Last update:2021-04-05, 1400/01/16
Update count:3
Registration date
2018-06-16, 1397/03/26
Registrant information
Name
Houri Alijani
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3243 0360
Email address
alijani@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences, Faculty of Nursing, Midwifery of Boyeh
Expected recruitment start date
2017-11-16, 1396/08/25
Expected recruitment end date
2018-06-15, 1397/03/25
Actual recruitment start date
2017-11-16, 1396/08/25
Actual recruitment end date
2018-05-15, 1397/02/25
Trial completion date
2018-05-15, 1397/02/25
Scientific title
The Effect of group educations based on Cognitive-Behavioral Techniques on fear of childbirth in primiparous mothers,
Public title
ٍThe Effect of group educations based on Cognitive-Behavioral Techniques on fear of childbirth in primiparous mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
low risk Nulliparous Women
ages between 18 to 35 years old
Gestational age between 20 to 28 weeks
The desire to participate in the study
Score questionnaire 55 and above
Exclusion criteria:
Participate in psychological training classes
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:
108
Actual sample size reached:
104
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 Golestan University of Medical Sciences
Street address
Hirkan Blvd.,The Shast kola Ave., Deputy of research and technology., Golestan University of Medical Sciences., Gorgan Town
City
Gorgan city
Province
Golestan
Postal code
4934174515
Approval date
2017-10-17, 1396/07/25
Ethics committee reference number
IR.GOUMS.REC.1396.143
Health conditions studied
1
Description of health condition studied
The effect of group educations based on Cognitive-Behavioral Techniques on fear of childbirth in primiparous mothers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
fear of birth
Timepoint
Before of the intervention and 8 week after intervention
The first Intervention group: Includes nulliparous pregnant mothers who will have routine pregnancy training. These training will be conduct in eight weekly sessions and in accordance with the Ministry of Health protocol in group of 6 to12 pregnant mothers and includes the first session; anatomy and physiology, common complaints during pregnancy, second session; nutrition, third session; personal and mental health, fourth session; Signs of danger during pregnancy, fifth session; planning for delivery, cesarean or normal vaginal delivery, Solutions for reducing labor pain, Sixth Session; Maternal actions during childbirth , The seventh session; postpartum care and the eighth session; neonatal care and lactation. Each session consist of 45 minutes of theory training, half an hour of exercise and 20 minutes of relaxation.
Category
Behavior
2
Description
The second Intervention group: Includes nulliparous pregnant mothers who who tend to have cognitive behavioral training.These training will be conduct In eight weekly sessions, according to the Wijma 2017 protocol, pregnant mothers will be trained in groups of 5 to 7 mothers. Content of the first session: the first trimester of natural pregnancy, welcome, an overview of the rules and regulations of group counseling sessions, meet the members together, ask questions, the uncertainties and concerns of members about group meetings and consultants guidance, assessing the goals and expectations of members from counseling sessions, an attempt to create a safe and consensual space with the aim of accelerating the change process. Content of the second session: natural pregnancy In the second trimester, teaching ABCDE concepts in cognitive behavioral approach, listing fears, concerns and anxieties associated with pregnancy and childbirth, identifying methods to deal with anxiety situations and thoughts, feelings and behaviors associated with it, provides psychological information about the nature of anxiety and fear and how to Body responses when anxiety occurs. The content of the third session includes: natural third trimester pregnancy, self control exercises (scanning your thoughts, feelings and behaviors in anxious situations), respiratory retraining training, relaxation training (calming). The content of the fourth and fifth sessions includes: natural delivery, relief of pain, preparation and start of the training of controlling the anxious thoughts through Cognitive Restructuring Techniques (Such as: disaster, thinking stopping technique, and pay attention) and positive self reflection. The content of the sixth session includes: the first and second stages of normal delivery, internal exposure, with the aim of consciously and deliberately creating anxiety emotions to reject false evaluations of these feelings and silence of anxiety response. Contents of the 7th session: labor and natural delivery, critical situations of internal exposure with the aim of consciously and deliberately creating anxious emotions to reject false evaluations of these feelings and silence of anxiety response. Content of the 8th session: labor and natural delivery of the third stage, identification of factors that may be barrier the effectiveness of treatment, solutions for the relapse of fear, concerns and anxieties, describing individuals from their expectations of labor and delivery imminent, summarizing the content presented in the meetings.
Category
Behavior
3
Description
Control group: The pregnant Women who do not participate in any educational classes.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Gorgan city
Full name of responsible person
Houri Alijani
Street address
Kalantari 13., Shahid Rajaee Ave., Gorgan Health Center , Gorgan Town
City
Gorgan city
Province
Golestan
Postal code
4919689631
Phone
+98 17 3242 0710
Fax
+98 17 3242 9645
Email
alijani@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Honarvar
Street address
Shast kola Ave., Hirkan Blvd., Deputy of research and technology., Golestan University of Medical Sciences., Gorgan Town
City
Gorgan city
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 1660
Fax
+98 17 3242 1657
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
Houri Alijani
Position
Master's student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shast kola Ave., Hirkan Blvd., Faculty of Nursing Midwifery., Golestan University of Medical Sciences., Gorgan Town
City
Gorgan city
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 1660
Fax
+98 17 3242 1657
Email
alijani@goums.ac.ir
Web page address
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
Shast kola Ave., Hirkan Blvd., Faculty of Nursing Midwifery., Golestan University of Medical Sciences., Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4913815739
Phone
+98 17 3245 6900
Fax
+98 17 3242 5171
Email
borghei@goums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Houri Alijani
Position
Master's student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shast kola Ave., Hirkan Blvd., Faculty of Nursing Midwifery., Golestan University of Medical Sciences., Gorgan Town
City
Gorgan city
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 1660
Fax
+98 17 3242 1657
Email
alijani@goums.ac.ir
Web page address
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
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
Information on the main outcome or the like can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will be available to researchers working in academic and academic institutions
Under which criteria data/document could be used
The data will be available for scientific research with reference to the research. In order to access the data, they can reply to the person's email address.