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The Effect of Fetal Movement Counting on Maternal Fetal Attachment in Primiparous Women.

Protocol summary

Study aim
The Effect of Fetal Movement Counting on Maternal Fetal Attachment.
Design
In this research, 110 eligible women are seleced. Gaining scores less than 22 from the GHQ28 are included in the study.Then, non-randomly, by assigning individual days to the control group and the coupled days to the intervention group, they are divided into two groups.
Settings and conduct
Primigravid women of the two groups before intervention, are completing demographic and Cranley questionnaires.The intervention group, referred to the Social Security Therapeutic Center of Urmia,were trained to count their fetal movements for two weeks, and record it in a special form. The control group only completes the questionnaires and receives routine care. Participants will be blinded by assigning single and coupled days of control and intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ages of 18 to 35 years, At least elementary education, Familiarity with Persian and Turkish, Iranian nationality, Primigravid, Not having a history of abortion and infertility, Singleton pregnancy, Gastational age of 28 to 34 weeks, Wanted pregnancy, Not having vaginal bleeding in pregnancy, Gain score less than 22 from general health questionnaireGHQ28, Not having blood pressure in pregnancy, Not having heart disease and diabetes, Not having substance abuse and smoking, Not having a history of death for the loved ones in the last six months, Not having a history of mental disorders. Exclusion criteria : Vaginal bleeding, Increasing blood pressure in pregnancy, Diabetics during pregnancy, Premature rupture of membrane, The appearance of acute stress during the study, such as the death of loved ones.
Intervention groups
In the intervention group, counting and recording the movements of the fetus is taught in a special form. There is no training in the control group.
Main outcome variables
More attachment.

General information

Reason for update
Acronym
MFA
IRCT registration information
IRCT registration number: IRCT20180112038324N1
Registration date: 2018-03-10, 1396/12/19
Registration timing: registered_while_recruiting

Last update: 2018-03-10, 1396/12/19
Update count: 0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Sima Faraji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3348 5014
Email address
faraji.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-09, 1396/11/20
Expected recruitment end date
2018-04-30, 1397/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Fetal Movement Counting on Maternal Fetal Attachment in Primiparous Women.
Public title
Maternal Fetal Attachment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having ages of 18-35 years Having at least elementary education Familiarity with Persian and Turkish Iranian nationality The first Pregnancy Not having a history of abortion and infertility Singleton pregnancy Gastational age of between 28-34 weeks Gain score less than 22 from general health questionnaireGHQ28 Not having vaginal bleeding during pregnancy Not having blood pressure in pregnancy Not having heart disease and diabetes Not having substance abuse and smoking Not having a history of death for the loved ones in the last six months Not having a history of mental disorders Wanted pregnancy
Exclusion criteria:
Vaginal bleeding Having chronic blood pressure Multiparous women Multipel pregnancy Intra uterin growth retardation Surgical history Pregnant less than 28 weeks Pregnant more than 34 weeks Primigravid less than 18 years old Primigravid more than 35 years old
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, clinical caregivers, researcher and the analyst were not kept blin.Only the participants were kept blind.To avoid bias,odd days were assigned to the control group and only completed the questionnaires and received routine care.Couple days were assigned to the intervention group. Except completion of questionnaires, they received an intervention that included counting the movements of the fetus and recording it.
Placebo
Not used
Assignment
Other
Other design features
People in the intervention group should lie down to the left side to count the movements of the fetus by putting hands on the abdomen and feeling the movement of the fetus, and every day it will be recorded in a special form.This should be done for two weeks consecutively.Then, for each day, put a knot on the ribbon.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
1st Floor, Unit One, Shams Apartment, Alley4, Next to Gaz Compani, Molavi Street.
City
Urmia
Province
West Azarbaijan
Postal code
5719996785
Approval date
2017-08-28, 1396/06/06
Ethics committee reference number
IR.UMSU.REC.1396.172

Health conditions studied

1

Description of health condition studied
The Effect of Fetal Movement Counting on Maternal Fetal Attachment
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Maternal Fetal Attachment
Timepoint
Before and after the intervention
Method of measurement
Cranley's Maternal Fetal Attachment Scale

Secondary outcomes

1

Description
Counting Fetal Movements
Timepoint
After the intervention
Method of measurement
Putting hands on the abdomen and counting the number of fetal movements.

Intervention groups

1

Description
Intervention group: In this group, the Cranley's maternal fetal attachment questionnaire(MFAS) is completed before intervention.Then, counts of the movements of the fetus are taught to the mother by placing hands on the abdomen and paying attention to the movements of the fetus and counting it is done. Mothers count the movements of the fetus for two weeks each day and the number of it is recorded on the special form. For each day, just one knot is tied to the ribbon. After two weeks the special form and ribbon is delivered from the people and again, the MFAS questionnaire is completed by them.
Category
Behavior

2

Description
Control group:No training is given in this group. Only routine care is taken. Once at the beginning of the study, the MFAS questionnaire is completed by this group. Then, after two weeks and at the end of the study, the MFAS questionnaire was completed by the people of this group again.Data are analyzed before and after the intervention by SPSS software.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital and Polyclinic Specialty of Hazrat Fatemeh
Full name of responsible person
Sima Faraji
Street address
Emam Reza Hospital, Molavi Street. No.34, Policlnic Hazrat Fatemeh, Daneshkadeh Crossed, Kashani Street.
City
Urmia
Province
West Azarbaijan
Postal code
57199967858
Phone
+98 44 3198 2000
Fax
+98 44 3365 9928
Email
emamreza-urmia.hos@tamin.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Deputy Head of Research and Technology Department, University headquarters, Emergency alley end, Resalat Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Email
mohabbi@umsu.ac.ir
Web page address
http://www.research.umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Sima Faraji
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
1st Floor, Unit One, Shams Apartment, Alley4, Next To Gaz Company, Molavi Street.
City
Urmia
Province
West Azarbaijan
Postal code
5719996785
Phone
+98 44 3348 5014
Fax
Email
faraji.s@umsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sima Faraji
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
1st Floor, Unit One, Shams Apartment, Alley4, Next To Gaz Company, Molavi Street.
City
Urmia
Province
West Azarbaijan
Postal code
5719996785
Phone
+98 44 3348 5014
Email
faraji.s@umsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sima Faraji
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
1st Floor, Unit One, Shams Apartment, Alley4, Next To Gaz Company, Molavi Street.
City
Urmia
Province
West Azarbaijan
Postal code
5719996785
Phone
+98 44 3348 5014
Email
faraji.s@umsu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is shairable after unidentifiable people.
When the data will become available and for how long
Three months after printing results.
To whom data/document is available
For all researchers in medical sciences.
Under which criteria data/document could be used
Data, for any scientific research by referring to the above research can be used through valid sites.
From where data/document is obtainable
To the responsible email address of the author Mobile Number: 0098 9144475179 Name: Sima Faraji.
What processes are involved for a request to access data/document
A week after the call and correspondence via email.
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