The goal of this study is to to evaluate the effect of education father- fetus attachment on mental health of primipregnant mothers. This is a clinical trial research. Inclusion criteria mothers: first pregnancy; age between 18-35; ability to read and write; gestational age 32-28 weeks; single pregnancy; mental health score less than 23. inclusion criteria fathers :Complete a consent form; at least read and write; monogamy and The first experience of fatherhood .exclusion mothers criteria: history of psychological problems; history of acute or chronic medical conditions; infertility; high risk pregnancy ; Grief and stressful incidents occurred during the last 6 months. exclusion fathers criteria: history of drug and alcohol use; history of mental problems .This research was done on 60 pregnant mothers and their husbands who visit for prenatal care in the health centers of Mashhad city In the year of 1394-95. Couples randomly placed in two groups of 30 each for intervention and contro.Fathers intervention group receive father-fetal attachment training in the form of three session of 120 minute classes weekly. The woman in control group received routine prenatal care only. immediately and after 3 weeks (follow-up) Both intervention and control groups evaluate by father- fetus attachment questionnaires and Goldberg mental health questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016010225808N1
Registration date:2016-08-18, 1395/05/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-18, 1395/05/28
Registrant information
Name
Nassim Khajavian
Name of organization / entity
Departeman Biostatistic
Country
Iran (Islamic Republic of)
Phone
+98 51 5725 7678
Email address
khajaviann931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of father- fetus attachment education on mother's mental health
Public title
The effect of father- fetus attachment to the mother's mental health
Purpose
Supportive
Inclusion/Exclusion criteria
Mothers inclusion criteria: to complete the consent form, is of Iranian origin and resident of Mashhad, is the first pregnancy, gestational age based on LMP and ultrasound between 32-28 weeks of the first quarter, chronological age is 35-18 years; singleton pregnancy have twins, have the ability to read and write is not less than 22 mental health score. Inclusion criteria fathers: to complete the consent form, is of Iranian origin and resident of Mashhad, have the least literate; his first become fathers is to be monogamous..Mothers exclusion criteria: history of psychological problems, a visit to the psychiatric clinic, effective drugs, or admitted to the psychiatric hospital is facing, have a history of acute or chronic medical condition, have a high risk pregnancy, current drug use and alcohol during pregnancy, have a history of infertility, grief and traumatic and stressful events occurred during the last 6 months. Exclusion criteria fathers: drug and alcohol use have; a history of mental problems, referring to psychiatric clinics, psychiatric drugs that have or hospitalization, bereavement, traumatic and stressful events occurred during the last 6 months there is, in the absence of more than a training session
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:
60
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
Regional Committee for Medical Research Ethics Mashhad University of Medical Sciences
Street address
Vice President of Research and Technology, next to the cinema curb, Daneshgah Avenue, Mashhad, Iran
City
Mashhad
Postal code
Approval date
2015-12-05, 1394/09/14
Ethics committee reference number
IR.MUMS.REC.13940542
Health conditions studied
1
Description of health condition studied
pregnancy
ICD-10 code
z34
ICD-10 code description
Supervision of normal pregnancy
2
Description of health condition studied
Mother's mental health
ICD-10 code
F99
ICD-10 code description
Mental disorder, not otherwise specified
Primary outcomes
1
Description
Mother's mental health
Timepoint
At the beginning of intervention, intervention, follow-up
Method of measurement
Form Goldberg mental health
2
Description
Mental health of mothers
Timepoint
At the beginning of intervention, intervention, follow-up
Method of measurement
Weaver father-fetus attachment questionnaire
Secondary outcomes
1
Description
Effect of intervention
Timepoint
Three weeks after the intervention
Method of measurement
Natan H marital satisfaction questionnaire modified igneous - Social Support Questionnaire modified Cassidy
Intervention groups
1
Description
In the intervention group training 3 times a parent-baby attachment to parents (weekly) First session: Understanding the stages of fetal development problems, common physical changes pregnant women, Second session: Introduction to psychological changes and the importance of maternal mental health and its impact on the health of the family, duties of the spouses during pregnancy. Third session: Introduction to mental and physical changes in pregnancy. Fourth session : The role of the father, the concept of attachment and attachment parents - embryos, since the formation of parent-baby attachment, links to the fetus and mother-baby attachment behavior
Category
Other
2
Description
No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center staff
Full name of responsible person
Nosraty Ashraf
Street address
22 Aleey, Rostami street, Mashhad, Iran
City
Mashhad
2
Recruitment center
Name of recruitment center
Heath Center 22 Bahman
Full name of responsible person
Nosraty Ashraf
Street address
32 Alley, Mohammad Abad, Mashhad, Iran
City
Mahhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tafaghodi Mohsen
Street address
Vice President of Research and Technology, next to the cinema curb, Daneshgah Avenue, Mashhad, Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ashraf Nosraty
Position
Consultation on midwifery, Master
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ibn Sina Street, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3725 6651
Fax
Email
NosratyA1@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kobra Mirzakhani
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ibn Sina Street, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
MirzakhaniK@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Kobra Mirzakhani
Position
Master of Midwifery-the coach
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ibn Sina Street, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
MirzakhaniK@mums.ac.i
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)