Determining the effect of attachment behavior training to mothers on short-term health outcomes of preterm infants in neonatal intensive care units
Design
A clinical trial with a blind, randomized, one-way control group, including 80 randomly assigned to two groups
Settings and conduct
The setting of research is Amirkola Children's Hospitals and the Ayatollah Rouhani Hospital in Babol. After obtaining the necessary permissions and obtaining the approval of the Ethics Committee, The researcher explains the goals of the study to the mothers who entered the study. Then, randomly, the eligible subjects in the study are assigned to intervention and control groups. Before the intervention, At first meeting with mothers in the first 48 hours, the checklist for attachment behavior is completed by the researcher's assistance. For intervention group, attachment behaviors are taught by the researcher and the control group receives routine caregivers.Maternal attachment behaviors are re-examined at the time of discharge and the results are analyzed statistically
Participants/Inclusion and exclusion criteria
Mothers with premature infants admitted to Amirkola and Ayatollah Rouhani Children's Hospitals
Intervention groups
The intervention group is a group in which mothers' attachment behaviors are taught. The control group receives routine care
Main outcome variables
Mother's attachment behaviors;
Duration of full oral feeding in both groups;
Duration of admission
General information
Reason for update
Acronym
neonatal intensive care unit : NICU
IRCT registration information
IRCT registration number:IRCT20180718040513N1
Registration date:2018-12-25, 1397/10/04
Registration timing:registered_while_recruiting
Last update:2018-12-25, 1397/10/04
Update count:0
Registration date
2018-12-25, 1397/10/04
Registrant information
Name
Mojtaba Qanbari qalesari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
mojtaba.ghanbari@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of teaching attachment behaviors to mothers on the short-term health consequences of premature infants in NICUs.
Public title
effect of maternal attachment behaviors on the health of premature infants
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers who able to read and write
Neonates with birth weight< 1500
neonates with apgar scor>7
Exclusion criteria:
Mothers who are physical and mental ill
the prohibition on mothers breastfeeding
Mothers addiction to drugs and alcohol
neonates with congenital anomalies
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Each of the maternal infants who enter the study is randomly assigned a number, these numbers are randomly distributed among the questionnaires and the units are assigned to the intervention and control groups based on the number received
Blinding (investigator's opinion)
Single blinded
Blinding description
Mothers do not notice the presence of evaluators, and the checklist for the groups is encrypted with a code and the evaluator is blind to the groups. The data analysis is performed by a statistician who has no information about the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Research Ethics Committee
Street address
Mazandaran, Babol, Babol University of Medical Sciences, Health Research Cente
City
Babol
Province
Mazandaran
Postal code
۴۱۳۶۷-۴۷۱۷۶
Approval date
2018-08-05, 1397/05/14
Ethics committee reference number
ir.mubabol.hri.rec.1397.113
Health conditions studied
1
Description of health condition studied
Mother and neonate attachment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Duration of full oral feeding in both groups;
Timepoint
From admission to full oral feeding
Method of measurement
From the beginning of the first oral feeding of the neonate, according to the physician's order, until the neonate is able to fully nourish it (feeding without gavage)
2
Description
neonate weight
Timepoint
at the time of admission and discharge
Method of measurement
using the standard digital weighing scale
3
Description
duration of admission
Timepoint
from admission until discharge
Method of measurement
Calculate the number of days the newborn is admitted to the hospital, from the time of admission to the date of the doctor's order for the discharge of the baby
Secondary outcomes
1
Description
Mother's attachment
Timepoint
At the time of admission and discharge
Method of measurement
Avant attachment behavior scale
Intervention groups
1
Description
Intervention group: Attachment behaviors are taught to mothers of the intervention group, Maximum 48 hours after admission for 4 sessions, once a day and each session 20 -30 minute, face to face and on the neonate bedside. the content of education are Familiarity with neonatal care environment and equipment for the newborn, appearance and behavioral characteristics of premature neonates and behaviors related to attachment (emotional, Neighborhood, Care)
Category
Behavior
2
Description
Control group: routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amircola Child Hosital and Ayatolla rouhani Hosital
Full name of responsible person
Afsaneh Arzani
Street address
Faculty of Nursing&Medwifery,Babol University of Medical Sciences, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
a.arzani@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Deputy of research and technology, Babol university of medical sciences, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۵۴
Phone
+98 11 3219 0557
Fax
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mojtaba Qanbari qalesari
Position
Assistant rofessor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Babol university of medical science- nursing faculty
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Fax
Email
m2ghanbari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mojtaba Qanbari qalesari
Position
Assistant rofessor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Babol university of medical science- nursing faculty
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Fax
Email
m2ghanbari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mojtaba Qanbari qalesari
Position
Assistant rofessor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Babol university of medical science- nursing faculty
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Fax
Email
m2ghanbari@yahoo.com
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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The demographic characteristics of the samples, such as age, level of education, etc., Also information on the main outcome of the study are published in the form of a dissertation
When the data will become available and for how long
Immediately after publishing the results in dissertation form
To whom data/document is available
Data is accessible to the general public
Under which criteria data/document could be used
Data is accessible to the general public. The application is submitted electronically only by email: m2ghanbari@yahoo.com
From where data/document is obtainable
E.Mail: m2ghanbari@yahoo.com; arzaniaf@gmail.com
nursing and midwifery faculty, Babol University of Medical Sciences
What processes are involved for a request to access data/document
The applicant will be provided electronically about a month after submitting the application