Premature birth is a stressful process for families and supportive program can be a viable solution. The purpose of this study was the impact of the fathers of premature newborns participation in intervention-training program on mother-infant attachment and parental anxiety. This study is a randomized clinical trial that fathers of 60 premature infants hospitalized in neonatal intensive care unit Selected with a 1: 1 allocation will be divided into two intervention and control groups. control group fathers will received ward routine care but in intervention group, Two 45-minute training session using the display content and images with PowerPoint will implemented .The intervention group also will received a package contains a CD and a colored manual prepared by the researcher. At the end of the first session, they will visit he neonatal intensive care unit and other part of education will done at the baby's bedside. One day after the intervention, the parents have 3 days non-designated visiting hours for meeting personal needs and baby's care.
The mother-infant attachment with Avant checklist and parents anxiety with SpielBerger questionnaire will be measured in both groups in the beginning and end of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080613691N4
Registration date:2016-07-27, 1395/05/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-27, 1395/05/06
Registrant information
Name
Mohammad Arshadi Bostanabad
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
arshadi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-12-05, 1395/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
“Effect of educational- supportive intervention for fathers of premature newborn on mother-newborn attachment and parents anxiety”
Public title
“Effect of educational- supportive intervention for fathers of premature newborn on mother-newborn attachment and parents anxiety”
Purpose
Supportive
Inclusion/Exclusion criteria
(Baby Inclusion criteria : premature babies between 37-34 weeks of pregnancy; Apgar score of more than 7 minutes; lack of major congenital anormalies; two days after the adoption of childr; enLack of intubation ; One roll of; Having at least one meeting; the first time؛ Do not use aids fertility; Minimum weight 2000 gr; having oral feeding; wanted pregnancy)
( Parents Inclusion criteria: sign the consent and willingness to participate in the study ; there is no known mental problems ; having at least primary education ; living with his wife in Tabriz ; lack of medical staff)
( Exclusion criteria: The occurrence of adverse events during treatment (infant death) ; The reluctance of parents to continue reading ;Consumption of anti-anxiety drugs)
Age
To 2 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Tabriz University of Medical Sciences
Street address
Daneshgah Ave. Tabriz University of Medical Sciences
City
Tabriz
Postal code
5138947977
Approval date
2016-04-25, 1395/02/06
Ethics committee reference number
IR.TBZMED.REC.1395.99
Health conditions studied
1
Description of health condition studied
maternal-infant attachment
ICD-10 code
Z00.6
ICD-10 code description
Examination for normal comparison and control in clinical research programme
2
Description of health condition studied
anexity
ICD-10 code
f41.1
ICD-10 code description
generalized anexiety disorder
Primary outcomes
1
Description
anexity
Timepoint
before Intervention، post Intervention
Method of measurement
Spielberger questionnaire
Secondary outcomes
1
Description
mother-newborn attachment
Timepoint
before Intervention، post Intervention
Method of measurement
Inventory observation Avant
Intervention groups
1
Description
The intervention group will support educational interventions. The intervention will be done 2 days after admission to the intensive care unit for newborns.
Two meetings of a group that includes45-minute face-to-face with the parents of premature infants in the environment, equipment, personnel intensive care unit and medical care such as IV therapy, oxygen therapy, etc., and information on premature babies (behaviors and physical symptoms), the role of parents in protecting and caring for the baby and the mother, physical and emotional changes made to the mother after delivery, will be presented by the researcher using Power Point.And questions and answers between the researcher and fathers topics will be presented.At the end of the first session of the color manual and CD training 40 minutes, with educational content developed by researchers and confirmed by the teachers, the parents and the parents will be taught how to use them.And at the end of the first session, parents to see the facilities and meet the staff, and training in the sector will be
The intervention group will support educational interventions.
The intervention 2 days after admission to the intensive care unit for newborns at will
Two meetings of a group that includes 60-minute face-to-face with the parents of premature infants in the environment, equipment, personnel intensive care unit and medical care such as IV therapy, oxygen therapy, etc., and information on premature babies (behaviors and physical symptoms), the role of parents in protecting and caring for the baby and the mother, physical and emotional changes made to the mother after delivery, will be presented by the researcher using Power Point
Category
Treatment - Drugs
2
Description
In the control group، Fathers will be visit their infants as ward routine and will be have no accessibility to rsearch team during hospitalization.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
29 Bahman Hospital
Full name of responsible person
Kobra Ravanbakhsh
Street address
29 Bahman Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
ِDr. rashidi
Street address
Daneshgah Ave. Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arshadi Bostanabad Mohammad
Position
Assistant Professor
Other areas of specialty/work
Street address
South Sharyati Ave. Nursing and Midwifery Faculty
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
arshadi@tbzmed.ac.irarshadi-m@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)