198 pregnant women at 28 to 34 weeks, 18 to 40 years from Shiraz, low risk pregnancy,in hafez clinic will randomly divided into two groups(case and control)with Random allocation block. women in case group participate in attachment behaviors class to 6 weeks (one class per week) and every week they will follow-up until the end of pregnancy .Then their babies at birth, one month and three months evaluate on physical, psychological and motor development through questionnaires by the researcher and will be compared with control infants. then the results analyzed by spss software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042217393N1
Registration date:2014-06-29, 1393/04/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-29, 1393/04/08
Registrant information
Name
Akram Dokuhaki
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1622 0595
Email address
dokuhaki_a@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-02-17, 1392/11/28
Expected recruitment end date
2014-06-18, 1393/03/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of teaching attachment behaviors to pregnant mothers on physical,psychological and motor development indicators of infant.
Public title
The effect of attachment behaviors in pregnant mothers on infant.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:(18-40 year old women; single prenancy; from shiraz; low risk; in 28-34 weeks)
Exclusion criteria:(missed pregnancy; preterm labor; congenital disorder in infant)
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
198
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
Shiraz University of Medical Sciences
Street address
Zand, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2014-01-18, 1392/10/28
Ethics committee reference number
92-6857
Health conditions studied
1
Description of health condition studied
attachment behavior
ICD-10 code
P00
ICD-10 code description
Fetus and newborn affected by maternal conditions that may be unrelated to present pregnancy
Primary outcomes
1
Description
mental health
Timepoint
0 and 3 month
Method of measurement
checklist
Secondary outcomes
1
Description
phisycal indicator
Timepoint
0-1-3 month
Method of measurement
meter-balance
2
Description
phisycal development
Timepoint
3 month
Method of measurement
DDST
3
Description
mental health
Timepoint
0-3 month
Method of measurement
checklist
Intervention groups
1
Description
attachment behavior
Category
Behavior
2
Description
without any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Marzie Akbarzade
Street address
Hafez hospital-Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Zand, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Shiraz University of Medical Sciences
Full name of responsible person
Akram Dokuhaki
Position
master of education in midwifery
Other areas of specialty/work
Street address
Shiraz
City
Shiraz
Postal code
Phone
+98 71 1622 0595
Fax
Email
AkramDokuhaki@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
AkramDokuhaki
Position
master of education in midwifery
Other areas of specialty/work
Street address
Shiraz
City
Shiraz
Postal code
Phone
+98 71 1622 0595
Fax
Email
AkramDokuhaki@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
AkramDokuhaki
Position
master of education in midwifery
Other areas of specialty/work
Street address
Shiraz
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)