Protocol summary
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Study aim
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Determine the effect of group training based on cognitive-behavioral techniques on fear of of Childbirth in Nulliparous Women
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Design
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Field trial with one control group and two parallel intervention groups
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Settings and conduct
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This study will be done at health centers in Gorgan city. Nulliparous mothers with a FOB score higher than55, based on mother tendency to participate in training sessions were divided into intervention and control groups.
The women in the intervention group who had tendency to participation in training class were randomly assigned to two subgroups .The first intervention group passed eight sessions of pregnancy training class and the second intervention group passed eight sessions of cognitive behavioral therapy education, and control groups were people who didn't Participation receive any training.
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Participants/Inclusion and exclusion criteria
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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)
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Intervention groups
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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.
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Main outcome variables
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fear of Childbirth
General information
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Reason for update
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Change in date and number of realized sampling and random assignment was not done due to ethical consideration and assigned two groups (intervention ,control) based on Personal desire
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171026037015N3
Registration date:
2018-06-16, 1397/03/26
Registration timing:
retrospective
Last update:
2021-06-27, 1400/04/06
Update count:
3
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Registration date
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2018-06-16, 1397/03/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Golestan University of Medical Sciences, Faculty of Nursing, Midwifery of Boyeh
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Expected recruitment start date
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2017-11-16, 1396/08/25
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Expected recruitment end date
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2018-06-15, 1397/03/25
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Actual recruitment start date
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2017-11-16, 1396/08/25
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Actual recruitment end date
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2018-05-15, 1397/02/25
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Trial completion date
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2018-05-15, 1397/02/25
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Scientific title
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The Effect of group educations based on Cognitive-Behavioral Techniques on fear of childbirth in primiparous mothers,
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Public title
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ٍThe Effect of group educations based on Cognitive-Behavioral Techniques on fear of childbirth in primiparous mothers
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
108
Actual sample size reached:
104
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-10-17, 1396/07/25
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Ethics committee reference number
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IR.GOUMS.REC.1396.143
Health conditions studied
1
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Description of health condition studied
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The effect of group educations based on Cognitive-Behavioral Techniques on fear of childbirth in primiparous mothers
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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fear of birth
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Timepoint
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Before of the intervention and 8 week after intervention
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Method of measurement
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WDEQ (Wijma Delivery Expectancy, Experience Questionnaire)
Intervention groups
1
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Description
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The first Intervention group: Includes nulliparous pregnant mothers who passed routine pregnancy training. These training was 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 consisted of 45 minutes of theory training, half an hour of exercise and 20 minutes of relaxation.
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Category
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Behavior
2
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Description
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The second Intervention group: Includes nulliparous pregnant women who passed cognitive behavioral training.These training was 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.
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Category
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Behavior
3
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Description
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Control group: The pregnant Women who do not participate in any educational classes.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Gorgan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Information on the main outcome or the like can be shared.
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When the data will become available and for how long
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Start the access period 6 months after printing the results
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To whom data/document is available
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Data will be available to researchers working in academic and academic institutions
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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esponsible person's email address: Houri Alijan
alijani@goums.ac.ir
alijani1349@gmail.com
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What processes are involved for a request to access data/document
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Applicants can respond to the email of the respondent and receive a response within a week.
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Comments
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If you do not reply to the first email address, please send a second email.