The effectiveness of group counseling with a solution- focused approach on childbirth fear, pregnancy, anxiety and cesarean preference in women participating in physiologic delivery training classes
The purpose of the study was to determine the effect of group counseling with a solution- focused approach on childbirth fear, pregnancy anxiety, and cesarean preference in women participating in physiologic delivery training classes in Mobini hospital in 1398
Design
A randomized controlled trial is conducted on 132 pregnant women with 28 weeks of gestational age referred to physiologic delivery training classes in Mobini hospital. Samples are selected through convenience sampling and randomly allocated to two test (66 people) and control (66 people) groups. The data will be collected using a demographic characteristics checklist, Wijma fear of childbirth questionnaire (version A) and pregnancy anxiety before and after intervention.
Settings and conduct
This study will be conducted on pregnant women referring to physiologic delivery training classes in the Mobini hospital of Sabzevar city. Participants will be randomly assigned into two groups of counseling and control through block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gestational age 28-36; Willingness to participate in research; Have reading and writing skills; First pregnancy; Age range 18-45; Single pregnancy; Wanted pregnancy
Non entry criteria: Chronic disease such as heart disease, hypertension, diabetes mellitus; History of abortion; Bleeding; Placenta previa; Use of certain drugs; Mental illness during the last year; Drug addiction and cigarette smoking
Intervention groups
In the intervention group, group counseling with a solution- focused approach runs in four, 90-minute sessions starting from the 28th week to the 36th week of pregnancy.The control group, only attend in physiologic delivery training classes in Mobini hospital
Main outcome variables
Fear of childbirth; Cesarean preference; Pregnancy anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170827035934N3
Registration date:2019-05-09, 1398/02/19
Registration timing:prospective
Last update:2019-05-09, 1398/02/19
Update count:0
Registration date
2019-05-09, 1398/02/19
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4466 9189
Email address
maryammehrabady@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of group counseling with a solution- focused approach on childbirth fear, pregnancy, anxiety and cesarean preference in women participating in physiologic delivery training classes
Public title
The effectiveness of group counseling solution- focused on childbirth fear, pregnancy, anxiety and cesarean preference
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 28-36; Willingness to participate in research; Have reading and writing skills; First pregnancy; Age range 18-45; Single pregnancy; Wanted pregnancy
Exclusion criteria:
Chronic disease such as heart disease, hypertension, diabetes mellitus; History of abortion; Use of certain drugs; Bleeding; Placenta Previa; Mental illness during the last year; Drug addiction and cigarette smoking
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be conducted using the website www.random.org and through blocking with block sizes of six and an allocation ratio of 1: 1 to the two groups of counseling and control
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, statistician was blinded. He analyzed the data while he did not know the assignment of patients to the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Campus of the University of Medical Sciences, after Grave of Unknown Martyrs, Tohid Shahr boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2019-03-17, 1397/12/26
Ethics committee reference number
IR.MEDSAB.REC.1397.119
Health conditions studied
1
Description of health condition studied
Fear of Childbirth
ICD-10 code
F40.8
ICD-10 code description
Other phobic anxiety disorder
2
Description of health condition studied
cesarean preference
ICD-10 code
O82
ICD-10 code description
Single delivery by caesarean section
3
Description of health condition studied
pregnancy anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Fear of Childbirth
Timepoint
Before intervention, after intervention
Method of measurement
Wijma fear of childbirth questionnaire, A version
Secondary outcomes
1
Description
childbirth method selection
Timepoint
Before intervention, after intervention
Method of measurement
childbirth method selection questionnaire
2
Description
Anxiety pregnancy
Timepoint
Before intervention, after intervention
Method of measurement
Anxiety pregnancy questionnaire
Intervention groups
1
Description
Intervention group: In the intervention group, group counseling with a solution- focused approach are performed in the form of four ninety-minute sessions ranging from 28 weeks to 36 weeks of gestation.
Category
Prevention
2
Description
For the control group, only delivery training classes will be held.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
physiologic delivery training classes in Sabzevar Mobini hospital
Full name of responsible person
Maryam Mehrabadi
Street address
Unit One, No. 30, Farhangian 10 Alley, Farhangian Avenue
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618745111
Phone
+98 51 4466 9189
Email
maryammehrabady@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr Fereshteh Ghorat
Street address
Campus of the University of Medical Sciences, after Grave of Unknown Martyrs, Tohid Shahr boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1300
Email
info@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Maryam Mehrabadi
Position
MSc in Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Unit One, No 30, Farhangian10 Alley, Farhangian Avenue
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618745111
Phone
+98 51 4466 9189
Email
maryammehrabady@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Forough Mortazavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Campus of the University of Medical Sciences, after Grave of Unknown Martyrs, Tohid Shahr boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1300
Email
frmortazavi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Maryam mehrabadi
Position
MSc in Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Unit One, No 30, Farhangian10 Alley, Farhangian Avenue
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618745111
Phone
+98 51 4466 9189
Email
maryammehrabady@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Data of participants are privacy.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The results of clinical study will be published as article.
When the data will become available and for how long
Immediately after publishing the results.
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article.
From where data/document is obtainable
Email: frmortazavi@yahoo.com
What processes are involved for a request to access data/document
Maximum one week after the communication by email.