The effect of empowerment program for mothers with infants with heart disorders on their resilience and neonatal
Design
non-randomized clinical trial with control group on 60 mothers with infants with heart disease
It is not possible to randomly assign the intervention and control group due to the nature of the intervention, which is educational and in one place.
Settings and conduct
This study is a clinical trial and is performed individually for each mother. Sampling is done by available method among mothers and their infants admitted to the NICU ward of Imam Reza Hospital who meet the research criteria and are willing to participate in the study. Therefore, first the samples of the control group are included in the study .After receiving a written letter of introduction from the officials of the University of Medical Sciences, research unit selection form will be completed to check the inclusion criteria. The informed consent form is obtained. We will have a total of 60 samples in two groups (intervention group and control group). Then the designed intervention will be done within 9 days.
Participants/Inclusion and exclusion criteria
A baby with congenital heart disease
Has not had heart surgery.
No other chronic disease
not under mechanical ventilation.
Term or near term (above 35 weeks)
Direct care of the baby by the mother
Intervention groups
The intervention includes a mothers empowerment program in infant care as well as emotional empowerment in 4 one-hour sessions, performed every other day. In between sessions, the material taught is practically practiced by the mother under the supervision of the researcher. Their functional problems will be solved and their questions will be answered.
In the control group, education is done to mothers orally and by giving educational pamphlets.
Main outcome variables
Mother resilience,
Infant growth criteria (weight and head circumference)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200625047914N1
Registration date:2020-12-10, 1399/09/20
Registration timing:registered_while_recruiting
Last update:2020-12-10, 1399/09/20
Update count:0
Registration date
2020-12-10, 1399/09/20
Registrant information
Name
rayehe joneidy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 3015
Email address
joneidir971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-05, 1399/05/15
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of empowerment program for mothers of infants with congenital heart disease on their resilience and neonatal growth criteria
Public title
The effect of empowerment program for mothers of infants with congenital heart disease on their resilience and neonatal growth criteria
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
infant with congenital heart disease
Term or near term (above 35 weeks)
Direct care of the baby by the mother
Exclusion criteria:
Has not heart surgery
No other chronic disease
No history of birth of a baby with heart disease in family
Not bad state and not under mechanical ventilation.
The mother does not have a known mental disorder or the mother is taking neuroleptics
Not experiencing severe accidents (such as death of loved ones) in 6 months
Age
From 1 day old to 10 days old
Gender
Both
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
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mashhad univercity of Medical Sciences
Street address
Ebne sina Street
City
mashhad
Province
Razavi Khorasan
Postal code
93145856263
Approval date
2020-06-02, 1399/03/13
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.024
Health conditions studied
1
Description of health condition studied
congential heart disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Resilience score in Conner-Davidson Resilience Questionnaire. In this questionnaire, the maximum score is 125 and the minimum score is zero, and the score of each subject is equal to the total score of each of the questions.
Timepoint
after the intervention and at one month of age
Method of measurement
For maternal resilience variable: Connor-Davidson resilience questionnaire
2
Description
infant growth criteria( weight and head circumference)
Timepoint
after the intervention and at one month of age
Method of measurement
Measure the infant's weight and head circumference
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first meeting, an introduction will be made and explanations will be given about the study and the baby's illness . The next day, an emotional empowerment session will be held to teach coping techniques and stress management techniques. The third session will teach them about the impact of nutrition and nutrition on improving the condition of patients with congenital heart disease. .The fourth session is about drugs and the importance of their correct and timely use, their side effects and how to control them.On the last day and the fifth session, will be explained to the mothers about the effect of the infection and its symptoms on the baby and how to control and prevent the infection and the necessary care in case of infection of the infant.The duration of the sessions will vary from 45 minutes to one hour and a day, depending on the mother's needs. The teaching method is in the form of lectures, practical demonstrations, questions and answers, showing educational videos through mobile phones and role-playing. During the sessions with the mothers, the given exercises will be reviewed and practiced more. And if needed, mothers' questions will be answered.
Category
Lifestyle
2
Description
Control group: In the control group, routine care is provided for nutrition and medication, and trainings are also given orally by the nurse or giving pamphlet to mothers.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Mashhad
Full name of responsible person
Dr. Naghmeh Razaghi
Street address
Ebne Sina Street
City
mashhad
Province
Razavi Khorasan
Postal code
9314733333
Phone
+98 51 3859 1511
Email
joneidir971@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodim
Street address
Daneshgah Street
City
mashhad
Province
Razavi Khorasan
Postal code
9314733333
Phone
+98 51 3335 0913
Email
tafaghodim@mums.ac.ir
Grant name
Vice Chancellor for Research, Mashhad University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Naghmeh Razaghi
Position
Assistant Professor - faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ebne sina Street
City
mashhad
Province
Razavi Khorasan
Postal code
9314733333
Phone
+98 51 3846 5038
Email
razaghin@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
dr.razaghi
Position
proffessor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
chahrah doctora
City
mashhad
Province
Razavi Khorasan
Postal code
93156465456
Phone
+98 51 3526 2652
Email
joneidir971@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Naghmeh Razaghi
Position
Assistant Professor- faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ebne Sina Street
City
mashhad
Province
Razavi Khorasan
Postal code
93156465456
Phone
+98 51 3859 1511
Email
Razaghin@mums.ac.ir
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
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, can be shared such as information about the main outcome, ie maternal resilience and infant growth criteria, .
When the data will become available and for how long
14 monthes
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
All requests are reviewed for access to data or documentation
From where data/document is obtainable
Refer to the researcher, Dr. Razaghi.
Email: razaghin@mums.ac.ir
What processes are involved for a request to access data/document
Just send an email. Will be answered within 3 days.