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The Effects of emotion regulation training on The level of Mother-to-Child Attachment in Mothers of Insecure Attachment in the First Pregnancy

Protocol summary

Summary
This study investigates the effects of emotion regulation training on mother-infant attachment in Mothers of Insecure Attachment in the First Pregnancy. Inclusion criteria: women 18-35 years old; pregnant; 30-34 week gestational age, at least secondary education, insecure attachment, lack of following in the past year: chronic diseases, mental disorders, major, on a psychiatrist or admitted drug consumption ; drug addiction. Exclusion criteria: Cancel mother; absence of more than one session, doing homework, birth before 37 weeks and after 41 weeks, weighing less than 2500 and more than 4000 grams. Random sampling method that divided the mothers into two groups. Two health centers in Mashhad, were selected randomly. The mother's eligible for both health center - treatment through questionnaires attachment Collins and Reid are determined. Mothers entered the study are insecure. Cassidy and Kranly completed questionnaires in both groups. For the intervention group, 8 sessions of emotional regulation based on dialectical behavior therapy, a two-hour sessions a week for two months in the training room runs. At the last meeting questionnaires Cassidy, Collins, Kranly and re-completed. The control group did not and only health center to receive prenatal care. 15-19 days after delivery to the filing mothers to newborns are admitted to both

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014100519407N1
Registration date: 2015-10-30, 1394/08/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-30, 1394/08/08
Registrant information
Name
Aliye Shojafar
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
shojafara1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Mashhad University of Medical Sciences
Expected recruitment start date
2014-11-13, 1393/08/22
Expected recruitment end date
2015-03-10, 1393/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of emotion regulation training on The level of Mother-to-Child Attachment in Mothers of Insecure Attachment in the First Pregnancy
Public title
The effects of emotion regulation training on maternal attachment to the baby in the mother's first pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for mothers: informed consent; gestational age between 30 and 34 weeks according to records; insecure attachment style mother by questionnaire Collins-Reed; age 18 to 35 years; first pregnancy; mothers at least guidance; lack of disease chronic mother like diabetes, hypertension, heart disease and epilepsy; the absence of major psychological disorders, psychiatric history, medication or hospitalization due to mental illness in the mother during the last year; no abuse and addiction drugs and stimulants, according to parents and health care records in; the absence of major stress in recent years (mother or wife's serious illness, death of a close, migration). Exclusion criteria during the study: criteria related to the mother include: withdrawing from further participation in the training sessions; the absence of the mother in more than a training session doing homework outside of class for more than one session; taking stimulants, narcotics, alcohol and smoking in our study; the incidence of major stress during the study period; the incidence of severe complications of pregnancy; separation of mother and baby for more than 24 hours after birth and during the study period; the mother died. Criteria for the newborn: birth before 37 weeks or after 41 weeks; birth weight less than 2,500 or more than 4,000 grams; congenital malformations in infants to prevent mother hugging baby; the baby died.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
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 deputy, Mashhad University of Medical Sciences
Street address
Research deputy, Qureshi Building, Daneshgah Street, Doctora Crossroads, Mashhad
City
mashhad
Postal code
Approval date
2014-10-28, 1393/08/06
Ethics committee reference number
research/930155/1/180

Health conditions studied

1

Description of health condition studied
Mothers in the First Pregnancy
ICD-10 code
Z34.0
ICD-10 code description
Supervision of normal first pregnancy

Primary outcomes

1

Description
The level of Mother-to-Child Attachment
Timepoint
15-19 days after delivery, after intervention
Method of measurement
Muller Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention1: Mother's insecure groups, trained in dialectical behavior therapy based on emotion regulation, at 8 weeks and 11-13 hours on Sundays every week (for two months).
Category
Behavior

2

Description
Intervention2: The control group only prenatal Health center according to the protocol, received no intervention does not occur to them
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center Shahrak-e-lashkar
Full name of responsible person
Reyhani Tayebe
Street address
Fatemiyeh 14-blvd Shahid Fallahi
City
Mashad

2

Recruitment center
Name of recruitment center
Health Center Najafi
Full name of responsible person
Reyhani Tayebe
Street address
Piroozi blvd
City
Mashad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research deputy, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Qureshi Building, Daneshgah Street, Doctora Crossroads, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy, 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
Aaliye Shojafar
Position
MSc in Nursing, Neonatal Intensive Care
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doctora Crossroads, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3868 6997
Fax
Email
shojafara1@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
Reyhani Tayebe
Position
MSc Nursing, Faculty member of School of Nursing and Midwifery, Mashhad
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doctora Crossroads, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Reyhanit@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
Aaliye Shojafar
Position
MSc in Nursing, Neonatal Intensive Care
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doctora Crossroads, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3868 6997
Fax
Email
shojafara1@mums.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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