Determining the effects of normal delivery education on childbirth fear and cesarean preference in pregnancy and postpartum in women referred to Sabzevar health clinics in 2017.
Design
A randomized controlled trial is conducted on 174 pregnant women with 20 weeks of gestational age referred to health centers and bases in Sabzevar. Samples are selected through convenience sampling and randomly allocated to two test (87 people) and control (87 people) groups. The data will be collected using a demographic characteristics checklist and Wijma fear of childbirth questionnaire (version A) before and after intervention and 14 days after childbirth.
Settings and conduct
This study was carried out at Sabzevar health centers and bases. In this study, statistician was blinded. He analyzed the data while he did not know the assignment of patients to the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gestational age 20-24; Willingness to participate in research; Have reading and writing skills; First or second pregnancy; Assessment of delivery as a scary event (score of 3 or more 5 Likert scale); Age range 18-35; Single pregnancy; Wanted pregnancy
Non entry criteria: Chronic disease such as heart disease, hypertension, diabetes mellitus; History of abortion and cesarean section; Bleeding Placenta previa; Use of certain drugs; Mental illness during the last year; Drug addiction and cigarette smoking
Intervention groups
In the intervention group, training program runs in eight, 90-minute sessions starting from the 20th week to the 24th week of pregnancy. Each session consists of two parts: a training (educational) section (45 minutes) and a practical training section (45 minutes).
There is not any intervention in control group. care and education will be done individually.
Main outcome variables
Fear of childbirth; Cesarean preference
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170827035934N2
Registration date:2018-02-05, 1396/11/16
Registration timing:registered_while_recruiting
Last update:2018-02-05, 1396/11/16
Update count:0
Registration date
2018-02-05, 1396/11/16
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
2018-01-04, 1396/10/14
Expected recruitment end date
2018-06-04, 1397/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of normal delivery education on childbirth fear and cesarean preference in pregnancy and postpartum in women referred to health clinics
Public title
The effects of normal delivery education on childbirth fear and cesarean preference in pregnancy and postpartum
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 20-24
Willingness to participate in research
Have reading and writing skills
first or second pregnancy
assessment of delivery as a scary event (score of 3 or more 5 Likert scale)
age range 18-35
single pregnancy
Wanted Pregnancy
Exclusion criteria:
Chronic disease such as heart disease, Hypertension, Diabetes mellitus
History of abortion and cesarean section
Bleeding
Placenta previa
Use of certain drugs
Mental illness during the last year
Drug addiction and cigarette smoking
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
174
Randomization (investigator's opinion)
Randomized
Randomization description
Number 1 (as test group) and number 2 (as control group) are written on two cards. Then we ask a co-worker to choose a card from these two cards. First ten participants are assigned to test or control group according to first number. Next 10 participants are assigned to the other group. This process will be repeated until the end of sampling.
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
2018-01-03, 1396/10/13
Ethics committee reference number
IR.MEDSAB.REC.1396.116
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
Primary outcomes
1
Description
Fear of Childbirth
Timepoint
Before intervention, after intervention, 14 days after childbirth
Method of measurement
Wijma fear of childbirth questionnaire, A version
Secondary outcomes
1
Description
childbirth method selection
Timepoint
Before intervention, after intervention, 14 days after childbirth
Method of measurement
childbirth method selection questionnaire
Intervention groups
1
Description
Intervention group: In the intervention group, training program runs in eight, 90-minute sessions starting from the 20th week to the 24th week of pregnancy. Each session consists of two parts: a training unit (45 minutes) and a practical training section (45 minutes).
Category
Prevention
2
Description
Control group will be administered by usual cares of the healthcare center.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar Health centers and Bases
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
دكتر فرشته قراط
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
Web page address
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
maryam.mehrabady@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Forough Mortazavi
Position
faculty member
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
sabzavar
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
maryam.mehrabady@yahoo.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
The sampling of this study will end before December 97.
There is no more information.
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