Protocol summary

Study aim
Objective: The effect of educational program based on attachment behaviors on the acceptance of maternal role in adolescent primigravida pregnant
Design
In this research, 80 eligible people referring to the selected medical centers are selected. Participants are randomly divide into intervention and control groups.
Settings and conduct
In this study, adolescent primigravida pregnant women who are referred to the selected treatment centers in Tehran are attending three sessions of the training course for three consecutive weeks.
Participants/Inclusion and exclusion criteria
Participants including major eligibility criteria: Mothers aged 15-19; Single pregnancy; Gestational age between 28 and 32 week Exit Conditions: absence training courses for more than one session; occur unpleasant and affecting event on the psyche of mother; Death of fetus or newborn; Admission of the newborn in intensive care unit
Intervention groups
Intervention group, Individuals participate in educational program based on attachment behaviors on 3 consecutive weeks for 90 minutes. Control group, receive routine care at selected clinics.
Main outcome variables
Acceptance of Maternal Role ( maternal identity, Parenting sense of competence)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171026037022N3
Registration date: 2018-03-07, 1396/12/16
Registration timing: retrospective

Last update: 2018-03-07, 1396/12/16
Update count: 0
Registration date
2018-03-07, 1396/12/16
Registrant information
Name
Asiyeh Kaheh
Name of organization / entity
Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 4608 5374
Email address
kaheei.a@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Iran University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2018-02-19, 1396/11/30
Trial completion date
empty
Scientific title
Effect Of Training Program Based On Attachment Behaviors On The Acceptance Of Maternal Role In Adolescent Nulliparous Pregnant Women
Public title
Effect of Training on Acceptance of Maternal Role
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers aged 15-19 Single pregnancy Gestational age between 28 and 32 weeks
Exclusion criteria:
Occur unpleasant and affecting event on the psyche of mother Death of Fetus or newborn Admission of the newborn in intensive care unit
Age
From 15 years old to 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 73
Randomization (investigator's opinion)
Randomized
Randomization description
The method of sampling in this study is available on a target-based basis and randomly assigned by binary block method in two groups of test and control. First, on the two cards, the numbers will be 1 and 2, then the qualified person will be asked to choose a card from the two cards. (Test group number 1 and control group number 2). Upon completion of the sampling, mothers will be placed in the selected clinics of prenatal care, in each of the groups of 10 who will be arranged in the initial drawing.
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 Iran University of Medical Sciences
Street address
School of nursing and midwifery, Yasemi Rashid Street, Vali-asr Street, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.IUMS.REC 1395.9311373023

Health conditions studied

1

Description of health condition studied
Acceptance of Maternal Role
ICD-10 code
F69
ICD-10 code description
Unspecified disorder of adult personality and behavior

Primary outcomes

1

Description
Maternal Identity
Timepoint
Before the intervention - Ten days after delivery
Method of measurement
Maternal Identity Questionnaire in the third trimester of pregnancy and postpartum

2

Description
Parenting Sense of Competence
Timepoint
Before the intervention - Ten days after delivery
Method of measurement
Parenting Sense of Competence scale

Secondary outcomes

1

Description
Maternal - fetal attachment
Timepoint
Before Intervention - Ten Days After Childbirth
Method of measurement
Cranly Maternal-fetal attachment questionnaire

Intervention groups

1

Description
Control group: The control group will receive routine care only.
Category
Other

2

Description
Intervention group: They will receive different training on attachment behaviors to the fetus for three consecutive weeks (three sessions - 90 minutes).
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Akbar Abadi Hospital
Full name of responsible person
Freshteh Jahdi
Street address
Shahid Akbar Abadi Hospital, Molavi Street, Tehran
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com

2

Recruitment center
Name of recruitment center
Lolagar Hospital
Full name of responsible person
Fereshteh Jahdi
Street address
Lolagar Hospital, Khosh street, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6683 5000
Email
lolagarhos@yahoo.com

3

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Freshteh Jahdi
Street address
Firoozgar Hospital, Vali-e-Asr Square, Tehran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
h_firoozgar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Morteza Naserbakht
Street address
Iran University of Medical Sciences, Next to Milad tower, Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fereshte Jahdi
Position
Ph.D. Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of nursing and midwifery, Yasemi Rashid street, Valiasr Street. Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8888 2886
Fax
Email
Jahdi.Fr@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Asiyeh Kaheh
Position
MSc student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Almas 2, mozafar Blvd, Shahid Baqeri Town, Tehran
City
Tehran
Province
Tehran
Postal code
1498964141
Phone
+98 21 4608 5382
Fax
Email
kaheh58540@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fereshteh Jahdi
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of nursing and midwifery, Yasemi Rashid Street, Valiasr street. Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8888 2886
Fax
Email
F.jahdi@iums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic data, Parenting Sense Of Competence Scale and Maternal identity (information on the main outcome) We explain how to collect data and methodology We publish Informed consent Form We publish the results of the research
When the data will become available and for how long
Availability since 1399
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Use of research and research results in medical centers
From where data/document is obtainable
Refer the library of the Faculty of Nursing and Midwifery of Iran.
What processes are involved for a request to access data/document
Refer the Library of the Faculty of Nursing and Midwifery of Iran.
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