Effect of counseling with emotional self-regulation approach versus control group on the anxiety and fear of childbirth in the primiparous women: a randomized clinical trial
To assess the effect of counseling with emotional self-regulation approach versus control group on the anxiety and fear of childbirth in the primiparous women
Design
This is a randomized clinical trial with control group without blinding, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Comprehensive Health Centers in Hamadan city on 70 eligible primiparous women. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 35 years
Gestation age 23 to 28 weeks
First singleton pregnancy
Being literate
Exclusion criteria:
Contraindications for natural childbirth
History of infertility
Mental illness
Having diabetes, high blood pressure, thyroid disorder
Smoking or drug use
Occurrence of pregnancy complications such as gestational diabetes, preeclampsia, placenta Previa
Intervention groups
Intervention group:
Routine care during pregnancy plus a counseling session with an emotional self-regulation approach for 45 to 60 minutes, one session per week for 6 sessions
Control group:
Just routine care during pregnancy
Main outcome variables
Primary outcome:
Anxiety and fear of pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N452
Registration date:2022-12-26, 1401/10/05
Registration timing:prospective
Last update:2022-12-26, 1401/10/05
Update count:0
Registration date
2022-12-26, 1401/10/05
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-03, 1401/12/12
Expected recruitment end date
2023-11-03, 1402/08/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of counseling with emotional self-regulation approach versus control group on the anxiety and fear of childbirth in the primiparous women: a randomized clinical trial
Public title
Effect of counseling with emotional self-regulation approach versus control group on the anxiety and fear of childbirth in the primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 35 years
Gestation age 23 to 28 weeks
First singleton pregnancy
Being literate
Exclusion criteria:
Contraindications for natural childbirth
History of infertility
Mental illness
Having diabetes, high blood pressure, thyroid disorder
Smoking or drug use
Occurrence of pregnancy complications such as gestational diabetes, preeclampsia, placenta Previa
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)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.UMSHA.REC.1401.723
Health conditions studied
1
Description of health condition studied
Anxiety and fear of childbirth in the first pregnany
ICD-10 code
O99.344
ICD-10 code description
Other mental disorders complicating childbirth
Primary outcomes
1
Description
Anxiety and fear of pregnancy
Timepoint
Before intervention and two weeks after
Method of measurement
Using Vanderberg Pregnancy Anxiety Questionnaire (PRAQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care during pregnancy plus a counseling session with an emotional self-regulation approach for 45 to 60 minutes, one session per week for 6 sessions (Including: the necessity of emotion regulation in pregnancy and childbirth, normal emotions and problematic emotions, emotional self-awareness, identifying and naming emotions caused by the birth process, differentiating between different emotions, identifying emotions in physical and psychological states, success factors in regulating emotions From pregnancy and childbirth, pathogenic emotions in pregnancy and the necessity of their treatment, cognitive consequences of emotional reactions, physiological consequences of emotional reactions, facing emotions, breaking core and problematic beliefs and replacing new beliefs)
Category
Other
2
Description
Control group: Just routine care during pregnancy
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Hamadan city
Full name of responsible person
Negar Masumi
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
azita.tizno@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
همدان
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
ngrmasumi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Azita Tiznobaik
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
azita.tizno@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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