Objectives:
The aim of this study was to determine the effect of fetal movement counting education on maternal fetal attachment in Iranian primigravida women.
Study design:
This clinical trial study was conducted in two intervention and control groups.
Setting and conduct:
Selective sampling was done on the base of major inclusion criteria in Isfahan selected health care centers. Then selected subjects were randomly assigned into control and intervention groups.
Intervention:
In addition to prenatal care, Intervention group was taught to count their fetal movement after consuming breakfast for 30 minutes in left lateral position for 1 month from 24 weeks of pregnancy.
In the control group, the usual education about prenatal care and fetal movements were done.
Main outcome measure:
At the beginning and end of the study, both groups completed the fetal attachment questionnaire. The main outcome of this study was the maternal fetal attachment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610183936N2
Registration date:2016-11-27, 1395/09/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-27, 1395/09/07
Registrant information
Name
Kobra Salehi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33 4243 2929
Email address
k_salehi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2014-04-29, 1393/02/09
Expected recruitment end date
2014-09-01, 1393/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education of foetal movement counting on maternal-fetal attachment in primiparous women
Public title
The effect of education of foetal movement counting on maternal-fetal attachment
Purpose
Supportive
Inclusion/Exclusion criteria
Major eligibility criteria:
Iranian women; first time pregnancy; being 18-35 years old; Having Literacy; having no medical problem during pregnancy or a history of mental disorders; normal pregnancy without use of ART; singleton pregnancy and gestational age between 22-20 weeks
Major exclusion criteria:
life threatening event during last 6 months; pregnancy with assisted reproductive treatment; multiple pregnancy; substances abuse before and during pregnancy
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
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
Isfahan University of Medical Sciences, Ethics Commitee
Street address
Hezar Jerib St, Isfahan
City
Isfahan
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
293259
Health conditions studied
1
Description of health condition studied
emotinal relationship between mother and fetus
ICD-10 code
O99.3
ICD-10 code description
Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Maternal fetal attachment
Timepoint
before and after intervention
Method of measurement
Cranly Maternal fetal attachment questionnaire
Secondary outcomes
1
Description
Effect of fetal movement counting education on recieving prenatal care
Timepoint
Before and After intervention
Method of measurement
Assessment of prenatal care folder
Intervention groups
1
Description
Control:
In the control group, the usual education about prenatal care and fetal movements were done.
Category
N/A
2
Description
Intervention:
In addition to prenatal care, Intervention group was taught to count their fetal movement after consuming breakfast for 30 minutes in left lateral position for 1 month from 24 weeks of pregnancy.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirieh Health Care Center
Full name of responsible person
Kobra Salehi
Street address
Amirieh Health Care Center, 4 th St, Amirieh Valley, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences, Vice Council of Research
Full name of responsible person
Dr Nematbakhsh M.
Street address
Isfahan University of Medical Sciences, Vice Council of Research, Hezar Jerib St, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences, Vice Council of Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences, Nursing and Midwifery School, Midwifery and Reproductive Hea
Full name of responsible person
Kobra Salehi
Position
PHD student of Reproductive Health
Other areas of specialty/work
Street address
Hezar Jerib St, Isfahan
City
Isfahan
Postal code
Phone
+98 31 5243 2929
Fax
Email
k_salehi@nm.mui.ac.ir; salehik1364@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences, Nursing and Midwifery School, Midwifery and Reproductive Hea
Full name of responsible person
Kobra Salehi
Position
PHD student of Reproductive Health
Other areas of specialty/work
Street address
Hezar Jerib St, Isfahan
City
Isfahan
Postal code
Phone
+98 31 5243 2929
Fax
Email
k_salehi@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences, Nursing and Midwifery School, Midwifery and Reproductive Hea
Full name of responsible person
Kobra Salehi
Position
PHD student of reproductive health
Other areas of specialty/work
Street address
Hezar Jerib St, Isfahan
City
Isfahan
Postal code
Phone
+98 31 5243 2929
Fax
Email
k_salehi@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)