Protocol summary

Study aim
Determining of The Effect of Educational Support based on Parenting Self-Efficacy on Attachment and Self-Efficacy of Mothers of Newborns Admitted in the NICU
Design
• Two arm parallel group trial with outcome assessment and simple randomization • The total sample is 84 people.
Settings and conduct
This research was carried out in the neonatal intensive care unit of Kashani Hospital. The mothers of the intervention group hold on Supportive education based on self-efficacy during three sessions. The mothers of the control group are routinely trained.
Participants/Inclusion and exclusion criteria
Interior Criteria: A newborn with gestational age above 36 weeks admitted in NICU. Exterior Criteria: 1) Serious illness of newborn during the study 2) Depression or postpartum psychosis during the study 3) Admission to the baby for more than 4 weeks 4) Discharge of the baby earlier than a week
Intervention groups
Mothers who have a baby admitted in the NICU are divided into two groups by coin throwing (according to the inclusion and exclusion criteria). The first group of mothers are received by the researcher during the 3-4 sessions of the neonatal developmental care program. The second group, which is the control group, includes mothers who receive routine training.
Main outcome variables
The main consequence of this study is increased self-efficacy and attachment in mothers with hospitalized infant.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150928024239N3
Registration date: 2018-02-06, 1396/11/17
Registration timing: registered_while_recruiting

Last update: 2018-02-06, 1396/11/17
Update count: 0
Registration date
2018-02-06, 1396/11/17
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66927171
Email address
zareiikh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-16, 1396/08/25
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Educational Support based on Parenting Self-Efficacy on Attachment and Self-Efficacy of Mothers of Newborns
Public title
The Effect of Educational Support based on Parenting Self-Efficacy on Attachment and Self-Efficacy of Mothers of Newborns in NICU
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
newborn with a gestational age older than 36 weeks are admitted to the NICU Ability for reading and writing in Persian language
Exclusion criteria:
Serious illness of newborn during the study Depression or postpartum psychosis during the study Admission to the baby for more than 4 weeks Discharge of the baby earlier than a week
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by throwing coins
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
ثبت نشده است.
Secondary trial Id
_
Registration date
2018-01-21, 1396/11/01

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical sciences
Street address
Faculty of Nursing and Midwifery Tehran, West Nusrat Street , Tohid Square , Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۷۱
Approval date
2017-11-12, 1396/08/21
Ethics committee reference number
IR.TUMS.FNM.REC.1396.3880

Health conditions studied

1

Description of health condition studied
Self-Efficacy - Attachment
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Avent checklist for measuring maternal and infant attachment behaviors.
Timepoint
Attachment questionnaire gets complete in the intervention and control groups in the 2nd week of admission by the researcher.
Method of measurement
Avent checklist.

2

Description
Self_efficacy by The Perceived Maternal Parenting Self_efficacy Questionnaire ) Barnes ---- and
Timepoint
The self- efficacy questionnaire will be done in 4th weeks after admission by the mothers of both groups.
Method of measurement
The Perceived Maternal Parenting Self_efficacy Questionnaire (Barnes)

Secondary outcomes

1

Description
Increased attachment
Timepoint
A week to ten days after being admitted.
Method of measurement
Avant mother attachment check list.

Intervention groups

1

Description
Intervention group: Mothers who have a baby admitted in the NICU can receive education during three sessions.The first session, they will introduc with the setting and the characteristics of the premature baby and its needs. During the second session, they discuss the developmental care philosophy and how to care for the baby based on the principles of developmental care on the model. The context includes care positions, correct movement, baby feeding, nursing care, bathing, and diaper change. The third session is conducted practically done by the mothers on their newborn in the presence of the researcher.
Category
Behavior

2

Description
Control group: Mothers who have a baby admitted in the NICU are received educational routine.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital,Tehran
Full name of responsible person
Fatemeh Tahmasebi
Street address
Second Square,Bukhara-ey Khzaneh Street,Besat Road,Tehan
City
Tehran
Province
Tehran
Postal code
1834893113
Phone
+98 21 5103 6230
Fax
+98 21 5506 1137
Email
Fatemeh.tahmasebi140@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Research Deputy of Tehran University of Medical Sciences
Street address
Tohid Square, Faculty Of Nursing and Midwifery Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
resdeputy@tums.ac.ir
Web page address
http://fnm.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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

2

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Maryam Modares
Street address
Sixth Floor,Central Organization of the University,Corner of Quds Street ,Keshavarz Blvd , Tehran University of Medical Sciences.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8898 7381
Fax
+98 21 8898 9664
Email
resdeputy@tums.ac.ir
Web page address
http://fnm.tums.ac.ir
Grant name
Medical University Tehran
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Tahmasbi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
1st Floor,No 5,Bozorgi Alley,Homay Street,Southern Majidiye Neighborhood.
City
Tehran
Province
Tehran
Postal code
1633656911
Phone
+98 21 2253 7635
Email
fatemeh.tahmasebi140@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Tahmasebi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Floor 1,No 5,Bozorgi Alley,Homay Street,Southern Majidiye Neighborhood
City
Tehran
Province
Tehran
Postal code
1633656911
Phone
+98 21 2253 7635
Email
fatemeh.tahmasebi140@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Tahmasebi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Floor 1,No .5,Bozorgi Alley , Homay St , Southern Majideh District
City
Tehran
Province
Tehran
Postal code
1633656911
Phone
+98 21 2253 7635
Email
fatemeh.tahmasebi140@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Only a portion of the data which is the main outcome information could be shared.
When the data will become available and for how long
A clinical study will report six months after the publication of the results
To whom data/document is available
Professors, and students who have permission from me and my professors.
Under which criteria data/document could be used
Not applicable to the public.
From where data/document is obtainable
baharzar42@gmail.com fatemeh.tahmasebi140@gmail.com And the Library of the Faculty of Medicine, which is the basis of the thesis.
What processes are involved for a request to access data/document
No documented documents except the thesis recorded in the University Library of the Faculty of Medical Sciences are currently available.
Comments
Only those written in the thesis are available, in which the thesis is also available at the Faculty Library.
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