The effect of home care follow-up program on premature newborns who receive NIDCAP, on mother's anxiety and stress and neonate's Physical growth parameters
Determining The effect of home care follow-up program on premature newborns who receive NIDCAP, on mothers’ anxiety and stress and neonates’Physical growth parameters
Design
Randomised, parallel group trial with blinded outcome assessment
Settings and conduct
To reduce the bias, control group data will first be collected. The mothers of the control group will receive regular care trainings during the hospital stay.After discharge the control group In the intervention group, Assessment Program NIDCAP is done by the researcher on the first day of the baby's birth، then every week and after the sustained condition of the newborn, every two weeks until the discharge is done.Its feedback is prepared by a person with an international certificate of NIDCAP and will be provided to the mothers. After one week after the discharge of the baby, the amount of anxiety and stress of the mother and growth parameters of the baby will be assessed.Re-assessment of NIDCAP will be done at home by a physician and a nurse and its developmental feedback will be provided to the mother. after one week, assessment of NIDCAP will be done at home by a nurse.
Participants/Inclusion and exclusion criteria
Mother Lack of known mental disorders in mothers. living in Mashhad.do not have any important or serious problem. did not experience any preterm infant birth.The baby's age is between 26-32 weeks. non anomaly and intracranial hemorrhage 3 and 4 and CLD.
Intervention groups
The study population includes mothers and their premature newborns admitted to the NICU of Omol-Banin Hospital of Mashhad
Main outcome variables
anxiety and stress-For mothers of the two groups, an Initial Spielberger Anxiety and Cohen Stress Questionnaire are completed. After the intervention, the Spielberger and Cohen Stress Anxiety Inventory was completed on the day of discharge and 2 months after discharge in two groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180127038529N1
Registration date:2018-05-30, 1397/03/09
Registration timing:registered_while_recruiting
Last update:2018-05-30, 1397/03/09
Update count:0
Registration date
2018-05-30, 1397/03/09
Registrant information
Name
Malihe Khoshahang
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3223 1065
Email address
khoshahangm1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of home care follow-up program on premature newborns who receive NIDCAP, on mother's anxiety and stress and neonate's Physical growth parameters
Public title
The effect of NIDCAP program on mother's anxiety and stress
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Mother consented to join to the program
Lack of known mental disorders in mothers
Mother is living in Mashhad
Mother is not addicted to drugs based on self-declaration
Mother do not have any important or serious problem
Mother did not have any twin or multiparty delivery
Mother did not experience any preterm infant birth
The baby's age is between 26-32 weeks
Exclusion criteria:
Usage of anti-anxiety drug by mother
Diagnosis of abnormalities in the baby
Age
From 6 months old to 8 months old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done in an accessible manner with simple random assignment
Blinding (investigator's opinion)
Double blinded
Blinding description
The intervention and control groups of mothers with preterm infants aged 32-26 who are blind to the purpose of the intervention. Data analysis is also conducted by the unacquainted person in the intervention and control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Imam Khomeini St., Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9144734767
Approval date
2018-01-10, 1396/10/20
Ethics committee reference number
IR.GMU.REC.1396.107
Health conditions studied
1
Description of health condition studied
mother’s anxiety and stress and neonate’s Physical growth parameters
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
Anxiety in mothers of premature infants
Timepoint
Determine mother's anxiety at beginning of study and after execution of the NIDCAP (the day of discharge of baby, before home care and at the end of 2-month period after discharge)
Method of measurement
Spielberger scale
2
Description
Stress in mothers of premature infants
Timepoint
Determine mother's stress at beginning of study and after execution of the NIDCAP (the day of discharge of baby, before home care and at the end of 2-month period after discharge)
Method of measurement
Cohen Perceived Stress Scale
3
Description
neonant's Physical growth parameters (such as weight, height, Head circumference, Chest circumference)
Timepoint
Determine neonant's Physical growth parameters at beginning of study and after execution of the NIDCAP (the day of discharge of baby, before home care and at the end of 2-month period after discharge)
Method of measurement
Meters and Weight Scales
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: includes the implementation the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) in accordance to the standards of this care program is done by the researcher on the first day of the baby's birth, and then every week and after the sustained condition of the newborn, every two weeks until the discharge is done.Its feedback is prepared by a person with an international certificate of NIDCAP and will be provided to the mothers. After one week after the discharge of the baby, the amount of anxiety and stress of the mother and growth parameters of the baby will be assessed and recorded.Re-assessment of NIDCAP will be done at home by a physician and a nurse and its developmental feedback will be provided to the mother. Then, after one week, assessment of NIDCAP will be done at home by a nurse and necessary trainings will be provided to the mother.
Category
Prevention
2
Description
Control group: In the control group received routine care