The assess Video Interaction Guidence of mother- infant interaction in mothers with premature neonates in Neonatal Intensive Care Units".
Design
trial with intervention and control group -80 mother- in acssess
Settings and conduct
Nullipara mothers with preterm infant 34-37 week that hospitalized in NICU in Imam hkomaeini and booalisina hospital in sari depended to Mazandaran University of Medical Sciences.
Participants/Inclusion and exclusion criteria
nullipara mothers with no history in preterm labour-mother with no difficault diseases- Iranian nationality-with lowest literacy of reading and writikg
Intervention groups
intervention group including 34 nullipara mothers who their preterm infant hospitalized in NICU. at first day,they filled pss questionaire(pretest) and then,recieved VIG(Video Interaction Guidence).then, at fourth day,intervention group recieved VIG and then filled pss questionaire(first posttest) and in seventh day, they recieved VIG and then filled pss questionaire (secound posttest).control group including 40 mothers compeleted pss questionaire in first day(pretest),fourth day(first posttest) and seventh day(secound posttest) and they recieved hospital routin care.
Main outcome variables
Mothers stress reducing who their preterm infant hospitalized in NICU
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170220032693N1
Registration date:2018-05-31, 1397/03/10
Registration timing:retrospective
Last update:2018-05-31, 1397/03/10
Update count:0
Registration date
2018-05-31, 1397/03/10
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4220 3877
Email address
maryambarzegar93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-24, 1396/10/03
Expected recruitment end date
2018-02-01, 1396/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Video Interaction Guidanceof mother-infant interaction on stress in mothers with premature neonates in Neonatal Intensive Care Units".
Public title
The effect of video interaction guidance of mother-infant interaction on stress in mother".
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Nullipara-
mothers with the lowest literacy in reading and writing
Iranian nationality- married
Not addiction with alcohol and extasia material
NO associated with difficault diseases
Exclusion criteria:
affected to depression
having preterm labour before this reseach
Age
From 21 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethic commitee of iran university of Medical Science
Street address
Shahid beheshti alley,Edalat 41, Rezvan building
City
Ghaemshahr
Province
Mazandaran
Postal code
4765754536
Approval date
2018-03-02, 1396/12/11
Ethics committee reference number
R.IUMS.REC.1395.9311451002.
Health conditions studied
1
Description of health condition studied
The effect of Video Interaction Guidence on preterm infants mother
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
mother stress
Timepoint
The first, fourth and seventh day
Method of measurement
questionaire-Likert
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Recieving Video Interaction Guidence.Intervention group compelete pss quesionaire(pretest) and then recieved Video Interaction Guidence in first day.then,theyrecieved Video Interaction Guidence in fourth day and filled pss questinaire(first posttest).in seventh day,mothers recieved Video Interaction Guidence and then filled pss questionaire(secound post test).
Category
N/A
2
Description
Control group: control group recieved just hospital routin care and filled pss questionaire in first day(pretest) and fourth day(first posttest) and seventh day(secound posttest).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali sina and Imam khomeini hospital
Full name of responsible person
Barzegar ,Maryam
Street address
No41,Edalat 41Alley,Shahid beheshti Street,Ghaemshahr town
City
Ghaemshahr
Province
Mazandaran
Postal code
4765754536
Phone
+98 11 4220 3877
Email
maryambarzegar93@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Seid Kazem Malakouti.
Street address
Shahid beheshti alley,41 Edalat , Rezvan building
City
Ghaemshahr
Province
Mazandaran
Postal code
4765754536
Phone
+98 11 4220 3877
Fax
Email
maryambarzegar93@gmail.com
Web page address
Grant name
20000000Rial
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
50
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
Maryam Barzegar
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid beheshti Alley,Edalat 41, Rezvan Building
City
Ghaemshahr
Province
Mazandaran
Postal code
4765754536
Phone
+98 11 4220 3877
Email
maryambarzegar93@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
Barzegar, Maryam
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid beheshti Street,Edalat41 Alley,Rezvan building
City
Ghemshahr
Province
Mazandaran
Postal code
4765754535
Phone
+98 11 4220 3877
Email
maryambarzegar93@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam barzegar
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid beheshti alley,Edalat41,rezvan building
City
Ghaemshahr
Province
Mazandaran
Postal code
476575536
Phone
+98 42203877
Fax
Email
maryambarzegar93@gmail.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
No - There is not a plan to make this available
Title and more details about the data/document
It possible some of data related to outcomes that intersect
When the data will become available and for how long
six month after resaults published
To whom data/document is available
Researcher who employed in association and university
Under which criteria data/document could be used
Useability of data should be with permitting responsible author.
From where data/document is obtainable
access to data by mobile phone
What processes are involved for a request to access data/document
connecting with responsible author by electronic post and mobile