Protocol summary

Summary
Attachment pattern that has been associated with human although the face is been changing. Emotional relationship is formed during pregnancy. After delivery, eye contact, smell, and touch the baby and mother will be increased. This type of contact can be found in skin contact for mother and baby after birth can establish interactive relationship between mother and baby. Quality of the parent-child relationship affects on mental, social and emotional health of each individual. And the Initial relationship between mother and child has long-term effects on child development. During lactation, Anxiety and depression in mothers is reduced due to the psychological satisfaction that is established for Mother. In regard to the first 4 weeks of life, infant life is so important and sensitive the most important factor in preventing morbidity and mortality is breast feeding. Attachment behavior training is a method of suitable non-drug therapy and non-invasive to reduce the psychological symptoms and to improve of mother attachment. Mother-to-infant attachment is definitely the health Physical and mental health is effective especially in adults in the future. Many psychoanalysts and psychologists believed that Core health any person lies in early attachment relationship between mothers - infant. Research in this direction In order to determine the factors maternal attachment - embryo decoding the way to the future mental health of the mother and child is widely considered their health. Training of attachment behavior should be considered from the beginning of pregnancy. This study will support the efficacy of psycho - social attachment of mother - child and impact on breastfeeding. This research is descriptive and clinical on 60 pregnant women (Not high risk and psychosis), early pregnancy, at least from 3 to 9 months to will be referred Vali Asr Hospital. This project will perform them. Pregnant women will participate with the knowledge and consent of the design goals of the study, the data receive by demographic and clinical diagnostic interviews, and questionnaire contained 14 main factors related to attachment and attachment rates of mother-to-baby check Avant. The questionnaire will be presented in early pregnancy samples, and then women randomly divided to two groups’ intervention and control. 30 patients will be in the intervention group and 30 patients in the control group. Intervention group in addition to routine prenatal care from 3 to 9 months, once or twice a month, six to eight sessions of supportive psychotherapy will be performed by clinical psychologist. The control group will receive routine care during pregnancy. The first visit is usually discharged after 3-7 days of birth at the end of the month and the first, third; sixth, ninth and twelfth mother to infant attachment behavior in groups will be monitored and recorded using checklists Avant. Attachment indicators before and after intervention in both groups and between groups were examined. The results led to will be increase in mental health mothers - the baby.

General information

Acronym
attachment of mother & breast feeding
IRCT registration information
IRCT registration number: IRCT2012091710746N1
Registration date: 2012-10-02, 1391/07/11
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-10-02, 1391/07/11
Registrant information
Name
Nasrin Abedinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2357
Email address
abedinia@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-12-15, 1392/09/24
Expected recruitment end date
2016-12-15, 1395/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey Support Social & Psychological Effects on attachment of mother – child and its effects on breast feeding
Public title
The survey Support Social & Psychological Effects on attachment of mother – child and its effects on breast feeding
Purpose
Health service research
Inclusion/Exclusion criteria
All pregnant women who have not high risk and severe mental health problems .
Age
From 20 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Research Council of Tehran University, Etics Committee
Street address
ghods Avenu Keshavarz Bluvar
City
Tehran
Postal code
Approval date
2012-08-27, 1391/06/06
Ethics committee reference number
18175

Health conditions studied

1

Description of health condition studied
Behaviour and Emotional disorder
ICD-10 code
F93
ICD-10 code description
Emotional disorders with onset specific to childhood

Primary outcomes

1

Description
Attachment
Timepoint
One or two times during pregnancy and postpartum months 1-3-6-9-12
Method of measurement
Questionnaire Avant

Secondary outcomes

1

Description
Social support,
Timepoint
Before and after study
Method of measurement
Questionnaire made by the researcher

2

Description
Self-esteem
Timepoint
Before and after study
Method of measurement
Questionnaire made by the researcher

3

Description
Anxiety and depression
Timepoint
Before and after study
Method of measurement
Questionnaire made by the researcher

Intervention groups

1

Description
Intervention group in addition to routine prenatal care from 3 to 9 months, once or twice a month, six to eight sessions of supportive psychotherapy will be performed by clinical psychologist. The first visit is usually discharged after 3-7 days of birth at the end of the month and the first, third; sixth, ninth and twelfth mother to infant attachment behavior in group will be monitored and recorded using checklists Avant. Attachment indicators before and after intervention in both groups and between groups were examined.
Category
Behavior

2

Description
The control group will receive routine care during pregnancy. The first visit is usually discharged after 3-7 days of birth at the end of the month and the first, third; sixth, ninth and twelfth mother to infant attachment behavior in group will be monitored and recorded using checklists Avant. Attachment indicators before and after intervention in both groups and between groups were examined.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Research Center of Breast feeding
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Tehran UniversityMaternal Fetal Neonatal Research Center
Full name of responsible person
Mamak Shariat
Street address
Maternal Fetal Neonatal Research Centervali Asr Hospital, Imam Khomeini Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Tehran UniversityMaternal Fetal Neonatal Research Center
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
Maternal Fetal Neonatal Health Research Center
Full name of responsible person
Nasrin Abedinia
Position
MSc Clinical psychologist
Other areas of specialty/work
Street address
Maternal Fetal Neonatal Research Center,vali Asr Hospital, Imam Khomeini Hospital
City
Tehran
Postal code
Phone
+98 21 6119 2357
Fax
Email
nasrin.abedinia@yahoo.com; nasrin.abedinia@gmail.com; abedinia@farabi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Maternal Fetal Neonatal Research Center
Full name of responsible person
Nasrin Abedinia
Position
MSc clinical psychologist
Other areas of specialty/work
Street address
Maternal Fetal Neonatal Research center vali asr hospital Imam Khomeini Hospital
City
Tehran
Postal code
Phone
+98 21 6119 2357
Fax
Email
nasrin.abedinia@yahoo.com; nasrin.abedinia@gmail.com; abedinia@farabi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mternal fetal neonatal health research center
Full name of responsible person
Nasrin Abedinia
Position
clinical psychologist
Other areas of specialty/work
Street address
vali asr hospital Mternal fetal neonatal health research center
City
Tehran
Postal code
14191
Phone
+98 61192357
Fax
+98 66591315
Email
nasrin.abedinia@yahoo.comabedinia@farabi.tums.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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