Investigating the effect of educational intervention based on the theory of planned behavior on the intention and behavior of Kangaroo mother care in the mothers who have premature infants hospitalized in the intensive care units of premature infants
Determining the effect of education based on the theory of planned behavior on the intention and behavior of kangaroo mother care in mothers with premature infants
Design
Quasi experimental design with pre-test, post-test in control and intervention group, based on training, with 60 people
Settings and conduct
Pre-test will be done through a questionnaire from both intervention and control groups. The face-to-face training intervention will take place in three sessions with once every two days. Training classes will be held at the hospital. Pictures and videos of kangaroo mother care will be used. Before discharging the infant, the post-test questions will be completed by the mothers participating in the study in both groups.
Participants/Inclusion and exclusion criteria
Having a premature baby (under 37 weeks), the mother's willingness to cooperate in the study, having a minimum of basic education, no problem with congenital anomalies, the mother has no history of infertility and the pregnancy is not the result of IVF. Having an Apgar score above 5 at birth, the baby weights more than 1200 grams, stable position of infant on the mechanical ventilation
Intervention groups
After obtaining informed consent from both groups, for the intervention group, face-to-face educational intervention based on the structures of the theory of planned behavior will be performed in three sessions on every two days. Training classes will be held with 3-4 people in each group at the hospital. The control group will receive routine training.
Main outcome variables
intention of kangaroo mother care, performing kangaroo mother care
General information
Reason for update
Acronym
KMC
IRCT registration information
IRCT registration number:IRCT20220407054443N1
Registration date:2022-05-24, 1401/03/03
Registration timing:registered_while_recruiting
Last update:2022-05-24, 1401/03/03
Update count:0
Registration date
2022-05-24, 1401/03/03
Registrant information
Name
Saeedeh Nemati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3368 7875
Email address
elnaznemati14@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-06-10, 1401/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of educational intervention based on the theory of planned behavior on the intention and behavior of Kangaroo mother care in the mothers who have premature infants hospitalized in the intensive care units of premature infants
Public title
The effect of educational intervention based on the theory of planned behavior on Kangaroo mother care in mothers who have premature infants
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in the study
Having a infant under 37 weeks hospitalized in the neonatal ward or NICU neonatal intensive care unit
Having a minimum of basic literacy
The baby should be in a stable condition on the mechanical ventilation
The baby may receive oxygen through a breathing tube, mask, or nose while caring for the baby, but the amount of oxygen needed should be approximately constant
The baby shall be kept in an incubator or cutter
Exclusion criteria:
having a fifth minute Apgar score less than 5
having less than 1200 grams weight.
having less than 30 weeks Intrauterine age of infant
During the last 12 hours, there is no need to change the device setting by doctor and nurse.
having no congenital malformations such as cleft palate, myelomeningocele, hydrocephalus and any other problems that lead to surgery and prevent the mother from being able to perform the usual care of a premature baby.
Maternal infertility history
Pregnancy resulting from IVF
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A pre-test will be performed through a questionnaire from both intervention and control groups. In the intervention group; an educational intervention will be conducted. Post-test will be done before discharging from hospital.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urzhans Ave , Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5719819762
Approval date
2022-03-09, 1400/12/18
Ethics committee reference number
IR.UMSU.REC.1400.469
Health conditions studied
1
Description of health condition studied
Kangaroo mother care
ICD-10 code
ICD-10 code description
2
Description of health condition studied
kangaroo mother care in mothers with premature infant
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intention of Kangaroo mother care in mothers who have premature infant
Timepoint
Before the intervention and when the baby is going to discharge
Method of measurement
Researcher-made questionnaire
Secondary outcomes
1
Description
Kangaroo mother care performing in mothers who have premature infant
Timepoint
Before the intervention and when the baby is going to discharge
Method of measurement
Researcher-made questionnaire
Intervention groups
1
Description
Intervention group: The face-to-face educational intervention will be done based on the structures of the theory of planned behavior in three sessions at every two days. Training classes in groups of 3-4 people will be held at the hospital. The educational content will be adjusted based on the needs assessment of the analysis of pre -test results. The educational content will be based on the structures of the theory of planned behavior. The duration of face-to-face training will be 45-60 minutes. content of the first session including: introduce and establish communication with the participants in the research, expression of purpose of the study, introduce kangaroo mother care, and readiness to do it. In the second session, prognosis related to premature infants, the consequences of kangaroo mother care, maternal and neonatal benefits of kangaroo mother care will be explained. In the third session, the father of the infant or one of relatives will be participate in secession, and barriers and facilitators of kangaroo mother care will be expressed. Lecture, question and answer strategy, and group discussion will be used in these sessions. Educational booklets, pamphlets, mobile phones, Whats App text messages, videos and pictures are used as teaching aid methods.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahzad Women's Comprehensive Educational and Medical Center
Full name of responsible person
Saeedeh Nemati
Street address
Hasani St.
City
Urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 44 3346 5079
Email
mahzad@umsu.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Motahari Educational and Medical Center
Full name of responsible person
Saeedeh Nemati
Street address
Kashani Street
City
Urmia
Province
West Azarbaijan
Postal code
5714615463
Phone
+98 44 3222 7002
Email
nursing_college@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Saber Golizadeh
Street address
Urmia University of Medical Sciences , Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 1930
Fax
+98 44 3224 0642
Email
Irajmohebbi@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Saeedeh Nemati
Position
Master student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Unit 7,Elin Apartment, First 16 Meters St.,Sadi St.
City
Urmia
Province
West Azarbaijan
Postal code
5719819762
Phone
+98 44 3368 7875
Email
elnaznemati14@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Roghaye Bayrami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery ,Nazlu Campus , Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
0098 44 327549614
Email
rozabayrami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saeedeh Nemati
Position
Master student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Unit 7,Elin Apartment, First 16 Meters St.,Sadi St.
City
Urmia
Province
West Azarbaijan
Postal code
5719819762
Phone
+98 44 3368 7875
Email
elnaznemati14@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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Publication of research results in the form of publishing a scientific article
When the data will become available and for how long
The access period starts 6 months after the publication of the article.
To whom data/document is available
All people
Under which criteria data/document could be used
To inform researchers and mothers with premature babies
From where data/document is obtainable
Dr. Roghieh Bayrami, Assistant Professor, School of Nursing and Midwifery, Urmia Email :rozabayrami@yahoo.com
What processes are involved for a request to access data/document
Enter the site of Urmia University of Medical Sciences and search for thesis title