1. Home
  2. Approved trials
  3. » فارسی

Assesing the effect of fathers involvement in the care of premature newborns based on developmental care principels on their bonding and self efficacy

Protocol summary

Study aim
Assesing the effect of fathers involvement in the care of premature newborns based on developmental care principels on their bonding and self efficacy
Design
This was a quasi-experimental study, performed on 80 fathers who had preterm infants in neonatal intensive care unit in two groups of control and intervention.
Settings and conduct
Neonatal intensive care units of Arash hospital affiliated to Tehran University of Medical Science
Participants/Inclusion and exclusion criteria
Inclusion criteria: Fathers who have premature baby (gestational age less than 37) in neonatal intensive care unit, the ability to understand and read in Persian, no addiction, not having a premature baby before. Exclusion criteria: The infant gets serious illness during the study (Lung hemorrhage, intraventricular hemorrhage...), mother with post par tum depression (the effect of mother depression on father bonding), hospitalization for more than 4 weeks (the effect of long hospitalization on fathers bonding and self- efficacy), discharge earlier than 1 week
Intervention groups
The control group includes fathers who filled demographic data form,mother to infant bonding scale and perceived parental self efficacy questionnaire in the first three days of application and again one month later. Their baby treat routinely. The intervention group includes fathers who participate in training sessions that researcher performed by using educational movies and medical moulages. In these session care processes, such as positioning, correct movement, feeding, kangaroo mother care, bathing of a swaddling baby, changing diapers, touching the baby, and understanding the behavior of the infant were educated with the participation of fathers and on their infants. Fathers filled demographic data form,mother to infant bonding scale and perceived parental self efficacy questionnaire in the first three days of application and again one month later
Main outcome variables
By implementing this plan, the level of self-efficacy and transplantation of fathers increased and the development of the baby will be affected

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171010036690N1
Registration date: 2018-01-31, 1396/11/11
Registration timing: retrospective

Last update: 2018-01-31, 1396/11/11
Update count: 0
Registration date
2018-01-31, 1396/11/11
Registrant information
Name
Fatemeh Morovati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
fmorovati@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-21, 1396/02/31
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
2017-05-21, 1396/02/31
Actual recruitment end date
2017-11-21, 1396/08/30
Trial completion date
empty
Scientific title
Assesing the effect of fathers involvement in the care of premature newborns based on developmental care principels on their bonding and self efficacy
Public title
Assesing the effect of fathers involvement in the care of premature newborns based on developmental care principels on their bonding and self efficacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Fathers who have premature baby (gestational age less than 37) in neonatal intensive care unit, the ability to undrestand and read in Persian, no addiction, not having a premature baby before
Exclusion criteria:
Exclusion criteria: The infant gets serious illness during the study (Lung hemorrhage, intra ventricular hemorrhage...), mother with post par tum depression (the effect of mother depression on father bonding), hospitalization for more than 4 weeks (the effect of long hospitalization on fathers bonding and self- efficacy), discharge earlier than 1 week
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
For preventing the information contamination between control and intervention group father will enter the study in succession of 10 people. The random sequence of the control and intervention group is determined by dropping coin. After ending sampling for 10 person and after discharging the last baby 10 father entered to study by the sequence identified.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Enghelab ave
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-05-06, 1396/02/16
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2241

Health conditions studied

1

Description of health condition studied
Assessing bonding and self- efficacy of fathers who have premature baby
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Bonding: The score obtained from the Mother to infant bonding questionnaire.
Timepoint
After 3 days, 4 weeks later
Method of measurement
The questionnaire of Mother to infant bonding scale.

2

Description
Self efficacy : The score obtained from the Perceived Parental self- Efficacy questionnaire
Timepoint
After 3 days, 4 weeks later
Method of measurement
Perceived Parental self- Efficacy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Fathers have a premature newborn that They are treated in accordance with the routine
Category
N/A

2

Description
Intervention group: Fathers have a newborn in the department that will participate in 4 sessions of evolutionary care education, including positioning, moving, feeding, nursing, bathing with a swaddling baby, changing diapers, touching the baby, understanding the behavior of the baby according to the nature of each infant. . After holding fathers' meetings with the help of the researcher, they performed the lessons learned on the baby's side as needed. During the first meeting with the infant's care department, the characteristics of the premature baby and its needs are taught to parents. During the second session, the philosophy of evolutionary care and how to care for the baby will be provided on the basis of the principles of evolutionary care on the replicate. During the third and fourth session, the care of the infant's bedside and in the presence of the researcher will be done by the fathers in practice.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash hospital
Full name of responsible person
Dr. Ladan Kashani
Street address
Shahid bagheri highway .Baghdarnia avenu
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 7788 3284
Email
hosp_arash@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Abasali Karimi
Street address
Enghlab ave
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8893 3766
Fax
+98 21 8892 5072
Email
tumspr@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

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh morovati
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
no 19, alireza sadegh nia alley, shohaday zia abad ave. barande seyfi blvd
City
Eslsmshahr
Province
Tehran
Postal code
3315688456
Phone
+98 21 5613 6589
Email
fatemehmorovati@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Morovati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No19, Alireza Sadegh nia alley, Shohadaye zia abad ave. Barande seyfi Blvd
City
Eslamshahr
Province
Tehran
Postal code
3315688456
Phone
+98 21 5613 6589
Email
fatemehmorovati@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh morovati
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No19, Alireza Sadeghnia Alley,Shohadaye ziaabad ave, Barande seyfi Blvd
City
Eslamshar
Province
Tehran
Postal code
3315688456
Phone
+98 21 5613 6589
Email
fatemehmorovati@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results will be sent as an article to be printed in internal or external journals
When the data will become available and for how long
Start access after printing the article
To whom data/document is available
All people
Under which criteria data/document could be used
If copyright is observed, mention the available resource
From where data/document is obtainable
fatemehmorovati@yahoo.com ظAn article in the journal has been published
What processes are involved for a request to access data/document
Within a week, an email request will be answered
Comments
Loading...