Protocol summary

Summary
Mental health during pregnancy has important effect on fetus growing and babies future adaptation. This is a clinical trial research. Participants were 150 first pregnant women between 28-34 weeks, who were recruited from simple sampling method. Participants in the 2 groups include control group and behavioral attachment group. Behavioral attachment group received an intervention that included four sessions of 90 minute classes weekly for expectant father include paternal fetal attachment, maternal fetal attachment, training and maternal –fetal interactive activities. The woman in control group received routine prenatal care only. Instruments were used in this study included information form, maternal –fetal attachment, paternal –fetal attachment, State- trait anxiety inventory. Observation of maternal fetal attachment in first breast feeding. Data was analyzed by tests such as: Chi-square test, one way analysis of variance. Inclusion criteria: primipar; age between 18-35; gestational age 28-34 weeks; normal pregnancy; single pregnancy; wanted pregnancy and low and moderate anxiety, father should have opportunity to participate in ejucation classes and fill up writingsatisfaction for;age of fathers should be under 45 and their minimum ejucation should be secondary school. Exclusion criteria: heart disease; mental disorder and complication in pregnancy such as vaginal bleeding, diabet, hypertention, preterm labor.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012091910886N1
Registration date: 2013-01-23, 1391/11/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-01-23, 1391/11/04
Registrant information
Name
sara setodeh
Name of organization / entity
Nursing & Midwifery Faculty
Country
Iran (Islamic Republic of)
Phone
+98 71 1230 7856
Email address
setodehs@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz Univecity of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fatherhood teaching attachment on the rate of mother fetus-neonate attachment and parents anxiety in primiparous pregnant women referred to Hospital affiliated to Shiraz University of Medical Sciences in 1391
Public title
Effect of fatherhood teaching attachment on the rate of mother fetus-neonate attachment and parents anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: primipar; age between 18-35 years; gestational age 28-34 weeks; normal pregnancy; single pregnancy; wanted pregnancy and low and moderate anxiety, father should have opportunity to participate in ejucation classes and fill up writingsatisfaction for;age of fathers should be under 45 and their minimum ejucation should be secondary school. Exclusion criteria: heart disease; mental disorder and complication in pregnancy such as vaginal bleeding, diabet, hypertention, preterm labor.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
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
Ethics committee of Shiraz University Of Medical Sciences
Street address
Central department of Shiraz University Of Medical Sciences,Zand Street, Shiraz
City
Shiraz
Postal code
713451978
Approval date
2012-08-23, 1391/06/02
Ethics committee reference number
00987112122389

Health conditions studied

1

Description of health condition studied
anexiety
ICD-10 code
f41.1
ICD-10 code description
generalized anexiety disorder

2

Description of health condition studied
pregnancy
ICD-10 code
Z34
ICD-10 code description
suprvision of normal pregnancy

Primary outcomes

1

Description
Anxiety
Timepoint
At the start of intervention- After intervention
Method of measurement
Spielberger questionnaire

Secondary outcomes

1

Description
Maternal fetal attachment
Timepoint
At the start of intervention- After intervention
Method of measurement
Cranly questionnaire(MFA)

2

Description
Paternal fetal attachment
Timepoint
At the start of intervention- After intervention
Method of measurement
Cranly questionnaire(PFA)

Intervention groups

1

Description
Intervention group: teaching maternal fetal attachment and paternal fetal attachment techniques to expectant fathers for a month ( 4 section weekly). first section: to get familiar to attachment meaning and to get familiar with different kinds of attachment techniques. second section: general meaning of stress ,symptoms,ways to control and relaxation meaning. 3th section: to get familiar with mental and physical changes in pregnancy. 4th section: to get familiar with paternal role to be connected with fetus
Category
Behavior

2

Description
Control group: the summary of whole teaching topics in the form of note afte the study will done.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Marziye Akbar Zade
Street address
Hafez Hospital, Abiverdi Squer
City
shiraz

2

Recruitment center
Name of recruitment center
Shoshtary hospital
Full name of responsible person
Khadije Abdali
Street address
Shooshtari Hospital, Shariaty Squer, Shiraz, Fars.
City
shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholam Reza Hatam
Street address
7th Flat, Central department of Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Shiraz University of Medical Sciences
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
Fatemeh College of Nursing And Midwifery, Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
Shiraz
Postal code
713451978
Phone
+98 71 1647 4258
Fax
Email
akbarzadehmarzieh@ yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fatemeh College of Nursing And Midwifery, Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4258
Fax
Email
akbarzadehmarzieh@ yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Fatemeh College of Nursing and Midwifery, Shiraz University of Medical Sciences
Full name of responsible person
Sara Setodeh
Position
Student, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square, Shiraz
City
Shiraz
Postal code
Phone
Fax
Email
setodehs@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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