Determining the emotion regulation educations' effect on fear of childbirth in primigravida women
Design
Field trial with control group, with parallel groups, first stage in accessible manner, randomized allocation method based on CAQ questionnaire scoring questionnaire
Settings and conduct
This study will be carried out in health centers of Gorgan. Blind will not be done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Be single
Her pregnancy is low risk.
According to her pregnant mother, she and her husband have not consumed drugs, psychotropic substances and alcohol in the last two months.
You do not have a history of infertility
Ask your pregnancy.
Minimum reading and writing education.
Exclusion criteria:Until the end of the study, they intend to migrate from Gorgan.
His wife and wife suffer from a known psychiatric illness, taking psychiatric medications or physical illnesses (cancers) and chronic illness over the past two months.
Have a degree in medical sciences, psychology, or counseling.
Have a history of infertility.
Intervention groups
The intervention group of the Gress-based Emotion-based Learning Training is taught to the test group. The control group does not receive any intervention.
Main outcome variables
Fear of giving birth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190210042672N1
Registration date:2019-03-09, 1397/12/18
Registration timing:retrospective
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Fatemeh bayenat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3242 8056
Email address
f.bayenat@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-01, 1397/08/10
Expected recruitment end date
2019-01-30, 1397/11/10
Actual recruitment start date
2018-11-01, 1397/08/10
Actual recruitment end date
2019-01-30, 1397/11/10
Trial completion date
2019-01-30, 1397/11/10
Scientific title
Investigation of emotion regulation educations' effect on fear of childbirth in primigravida women
Public title
Investigation of emotion regulation educations' effect on fear of childbirth in primigravida women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be single
Her pregnancy is low risk.
According to her pregnant mother, she and her husband have not consumed drugs, psychotropic substances and alcohol in the last two months.
You do not have a history of infertility
Ask your pregnancy.
Minimum reading and writing education.
Exclusion criteria:
Until the end of the study, they intend to migrate from Gorgan.
His wife and wife suffer from a known psychiatric illness, taking psychiatric medications or physical illnesses (cancers) and chronic illness over the past two months.
Have a degree in medical sciences, psychology, or counseling.
Have a history of infertility.
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:
64
Actual sample size reached:
62
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
Golestan University of Medical Sciences, Higher Education Complex, 1st Road of Shast Kola, Km 5 Gorgan Road to Sari
City
gorgan
Province
Golestan
Postal code
4934174515
Approval date
2018-10-09, 1397/07/17
Ethics committee reference number
IR.GOUMS.REC.1397.150
Health conditions studied
1
Description of health condition studied
Fear of childbirth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fear of childbirth in the CAQ delivery fear questionnaire
Timepoint
Before the intervention begins and immediately after the intervention is completed
Method of measurement
CAQ delivery fear questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Grass Exercise Therapy Initially, Grass's Modeling Excitement (8 sessions, two sessions per week and each session for 120 minutes in groups of 6-12 people who met during the first familiarization session) Communicating with each other, expressing the main and subordinate goals of the group, expressing the framework and rules of the participant in the group, expressing the logic and the stages of intervention, starting the relationship between the leader of the group, discussing the members about the sub-goals and the collective, the second meeting of the choice of position-goal , Emotional education, Third-session selection of target-position selection, assessment of the degree of emotional vulnerability, assessment of the emotional level of the members, the meeting. E-mail: Modifying Location-Target, Creating Change in Emotion-Driven Position, Fifth Session, Attention-Target Exercise, Teaching Skills, Sixth Session, Cognitive Evaluation-Objective, Modifying Cognitive Assessments, Seventh-Tentative Adjustment-Target, Modifying Consequences of Behavior and Physiological excitement, Eighth Assessment and Application-Purpose, Re-evaluation and Planning for the Application of Training) are taught by the researcher. Then, the difference in fear of delivery with the CAQ questionnaire is measured in the pre-test and post-test phase and compared with each other.
Category
Other
2
Description
Control group: There is no intervention. The difference in fear of delivery is measured by the CAQ questionnaire on pre-test and post-test phases and compared with each other.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Deputy of Health of Golestan University of Medical Sciences
Full name of responsible person
fatemeh bayenat
Street address
Golestan University of Medical Sciences, Higher Education Complex, 1st Road of Shast Kola, Km 5 Gorgan Road to Sari
City
gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 8056
Email
f.bayenat@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad reza Honarvar
Street address
Golestan University of Medical Sciences, Higher Education Complex, 1st Road of Shast Kola, Km 5 Gorgan Road to Sari
City
gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
honarvar@goums.a.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
fatemeh bayenat
Position
Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan University of Medical Sciences, Higher Education Complex, 1st Road of Shast Kola, Km 5 Gorgan Road to Sari
City
gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 8056
Email
f.bayenat@goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Asieh Sadat Baniaghilآسیه سادات بنی عقیل
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan University of Medical Sciences, Higher Education Complex, 1st Road of Shast Kola, Km 5 Gorgan Road to Sari
City
gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 8056
Email
a_baniaghil@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
fatemeh bayenat
Position
midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan University of Medical Sciences, Higher Education Complex, 1st Road of Shast Kola, Km 5 Gorgan Road to Sari
City
gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 8056
Email
f.bayenat@goums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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