The effects of Kangaroo Mother Care education intervention on the Premature Infants based on expanded health belief model : Shahid Sadoughi hospital ٬Yazd
The aim of this study was to investigate the effects of Kangaroo Mother Care education intervention on the Premature Infants based on expanded health belief model in Shahid Sadoughi hospital ٬Yazd.
Design
This research is a randomized controlled trial. The convenience or accidental sampling method, which will be done on 124 premature infants admitted to Shahid Sadoughi Hospital in Yazd, Iran, in two intervention and control groups.
Settings and conduct
At first, the control group after receiving routine training provided at the NICU of the hospital in relation to kangaroo care by the education officer for the mothers, the questionnaire of the variables considered including the characteristics of the newborn and the parents and the EHBM construct questionnaire for the mothers of this group is completed. After discharge, the EHBM constructs questionnaire and the outcome of the infant will be completed again.In the intervention group , the sampling was done in the same way as the control group based on the inclusion criteria of the study. After receiving the routine training , the questionnaires of the variables including newborn and parent characteristics and the EHBM construct questionnaire They will be completed. Then, all mothers in the intervention group receive a kangaroo care education based on the EHBM model and at the time of discharge, the EHBM construct questionnaire and the outcome of the newborn are completed.
Participants/Inclusion and exclusion criteria
Neonatal conditions for the study of gestational age less than 32 weeks, birth weight less than 1800 grams, sustained cardiovascular status at the start of kangaroo care and parents’ consent to participate and cooperate with the study .
Intervention groups
Interventions will include individual training sessions and small groups.
Main outcome variables
Baby weighing - Oxygen therapy time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181024041451N1
Registration date:2019-02-17, 1397/11/28
Registration timing:retrospective
Last update:2019-02-17, 1397/11/28
Update count:0
Registration date
2019-02-17, 1397/11/28
Registrant information
Name
Sedigheh Safari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9100
Email address
se.safari71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-16, 1397/07/24
Expected recruitment end date
2019-02-13, 1397/11/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Kangaroo Mother Care education intervention on the Premature Infants based on expanded health belief model : Shahid Sadoughi hospital ٬Yazd
Public title
The effects of Kangaroo Mother Care education intervention on the Premature Infants
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The gestational age is less than and equal to 32 weeks
the birth weight is less than and equal to 1800 grams
the cardiovascular condition is stable
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
One of the strengths of this study was its exploratory approach to the design of the research instrument. By measuring CVI and CVRs, an attempt was made to develop an adapted valid and reliable instrument to the conditions of the study population to objectively reflect mothers' perceptions;
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahid Sadoughi University of Medical Sciences in Yazd
Street address
School of Public Health, shahid Sadoughi University of Medical Sciences, Gomnam Shahid Blvd,Alem Square
City
Yazd
Province
Yazd
Postal code
891517316
Approval date
2017-07-03, 1396/04/12
Ethics committee reference number
IR.SSU.SPH.REC.1396.62
Health conditions studied
1
Description of health condition studied
premature infants
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mother's perceived sensitivity score
Timepoint
Before starting kangaroo care and time to discharge the baby
Method of measurement
Researcher-made questionnaire based on expanded health belief model
2
Description
Mother's perceived intensity score
Timepoint
Before starting kangaroo care and time to discharge the baby
Method of measurement
Researcher-made questionnaire based on expanded health belief model
3
Description
Mother's perceived benefit score
Timepoint
Before starting kangaroo care and time to discharge the baby
Method of measurement
Researcher-made questionnaire based on expanded health belief model
4
Description
The score of the perceived barriers of the mother
Timepoint
Before starting kangaroo care and time to discharge the baby
Method of measurement
Researcher-made questionnaire based on expanded health belief model
5
Description
The score of the Cues to action of the mother
Timepoint
Before starting kangaroo care and time to discharge the baby
Method of measurement
Researcher-made questionnaire based on expanded health belief model
6
Description
Mother's self-efficacy score
Timepoint
Before starting kangaroo care and time to discharge the baby
Method of measurement
Researcher-made questionnaire based on expanded health belief model
7
Description
Mother's perceived social support score
Timepoint
Before starting kangaroo care and time to discharge the baby
Method of measurement
Researcher-made questionnaire based on expanded health belief model
8
Description
Mother's Locus of control score
Timepoint
Before starting kangaroo care and time to discharge the baby
Method of measurement
Researcher-made questionnaire based on expanded health belief model
Secondary outcomes
1
Description
Weight of baby discharge time
Timepoint
At the time of discharge the baby
Method of measurement
Using Digital Scales
2
Description
The duration of oxygen therapy
Timepoint
At the time of discharge the baby
Method of measurement
Use of a baby's treatment file - The number of days the baby has received supplemental oxygen in any form.
3
Description
Duration of hospitalization
Timepoint
At the time of discharge the baby
Method of measurement
The sum of the days when the baby was admitted to the NICU due to complications of prematurity.
4
Description
retinopathy
Timepoint
At the time of discharge the baby
Method of measurement
Use of a baby's treatment file
5
Description
The death of babies
Timepoint
At the time of discharge the baby
Method of measurement
Whether or not a baby is alive
6
Description
Average baby's weight gain per day
Timepoint
Daily
Method of measurement
Using Digital Scales
Intervention groups
1
Description
Intervention group: In addition to routine hospital training, mothers with preterm infants also receive Kangaroo Care Education based on the Expanded Health Belief Model.
Category
N/A
2
Description
Control group: Only receive routine hospital training.
Shahid Sadoughi University of Medical Sciences,Shohadaye gomnam Blvd,Alem Square
City
Yazd
Province
Yazd
Postal code
891517316
Phone
+98 35 3820 9100
Email
se.safari71@gmail.com
Grant name
Research Deputy of Shahid Sadoughi University of Medical Sciences, Yazd
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Sedighe Safari
Position
MSC student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Shahid Sadoughi University of Medical Sciences,Shohadaye gomnam Blvd,Alem Square
City
Yazd
Province
Yazd
Postal code
891517316
Phone
+98 35 3820 9100
Email
se.safari71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hosseinali Sadeghian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Shahid Sadoughi University of Medical Sciences,Shohadaye gomnam Blvd,Alem Square
City
Yazd
Province
Yazd
Postal code
891517316
Phone
+98 35 3820 9100
Email
sadeghian.hossein@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sedighe Safari
Position
MSC student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Shahid Sadoughi University of Medical Sciences,Shohadaye gomnam Blvd,Alem Square
City
Yazd
Province
Yazd
Postal code
891517316
Phone
+98 35 3820 9100
Email
se.safari71@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Given the preparation of the article for the publication of scientific journals, individual data of unidentified samples will be available to reputable journals.
When the data will become available and for how long
3 months after the publication of the article, information will be provided to individuals upon request.
To whom data/document is available
Only those who are busy at university centers will have access.
Under which criteria data/document could be used
There are no other conditions to correspond with the author.
From where data/document is obtainable
Author responsible by email
What processes are involved for a request to access data/document
After submitting the application on average after one to two weeks