To determine the effect of an educational intervention on discharge readiness of preterm infants’ parents
Design
Two arm parallel group non randomized controlled trial, discharge education intervention with outcome parents readiness assessment
Settings and conduct
The place of the study Muhumbili and Mloganzila National Hospitals, Dar es Salaam;
The study populationParents of Preterm Infants.
Participants/Inclusion and exclusion criteria
Parents of preterm infants with a gestational age of less than 37 weeks; Parents are the main caregivers of preterm infants after discharge from the hospital; Being literate (at least elementary school education and above) parents of preterm infants; Parents with at least 18 years of age; Home as the child’s discharge destination; Parents, who are mentally stable and in fair condition based on parent self-report and review of their medical records by the researcher.
Exclusion Criteria
Parents of preterm infants with congenital anomalies;
Those neonates who need major operation;
neonates who are readmitted to the hospital;
Intervention groups
Intervention group: Parents in the intervention group will receive four sessions of discharge’s educational intervention. Each session will last for 60 minutes; the researcher will use lecture, questions and answers, using videos demonstration and discussion as the method of teaching the participants. After each session premature infants’ parents will be given handout about the teaching for memorizing.
Control group: Parents in the control group will only receive normal hospital discharge routine care.
Main outcome variables
Readiness score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231015059726N1
Registration date:2024-03-04, 1402/12/14
Registration timing:registered_while_recruiting
Last update:2024-03-04, 1402/12/14
Update count:0
Registration date
2024-03-04, 1402/12/14
Registrant information
Name
Glory Masimango
Name of organization / entity
Country
Tanzania, United Republic of
Phone
+255 787 633 695
Email address
masimangog6@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of an Educational Intervention on Discharge Readiness of Preterm Infant's Parents
Public title
Discharge Intervention on Readiness of Parents
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Parents of preterm infants with a gestational age of less than 37 weeks
Parents are main caregivers of preterm infants after discharge from hospital
Literate (at least elementary school education and above) parents of preterm infants
Parents with at least 18 years of age
Home as the child’s discharge destination
Parents, who are mentally stable and in fair condition based on parent self-report and review their medical records by researcher
24 hours post-delivery at intervention medical center or 48 hours post admission in NICU or HDU from peripheral hospitals
Exclusion criteria:
Parents of preterm infants with congenital anomalies
Those who need major operation
Who are readmitted to the hospital
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
this will be a random assignment between two hospitals, in which one hospital will be randomly assigned to be the control hospital and the other hospital will be assigned to be the intervention hospital.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
Mirkhani( nosrat) St; Tohid sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2023-10-15, 1402/07/23
Ethics committee reference number
IR.TUMS.FNM.REC.1402.143
Health conditions studied
1
Description of health condition studied
The current study is relevant to neonates health improvement, by conducting a program that prepare parents for neonates discharge.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Parents Readiness for Discharge. In this study we will use PedRHDS form for Parents of Hospitalized Children (including NICU) that consist of 29 (23) items in 5 subscales including: Parent Personal status = 1a,2a,3a,4a,5a,6۶a, 6b,7a (8 items); (items 2a, 5a, 6b should be reverse scored), Child Personal status = ۱b,۲b,۳b,۴b,۷b (۵ items): (item ۲b should be reverse scored), Knowledge = 8 to 16 (9 items), Coping Ability = 17-19 (3 items) and Expected Support = 20-23 (4 items). Scores are calculated by adding item scores and dividing by the number of items, thus calculating the RHDS score as the mean of item scores. The possible range of scores is 0 to 10 using this method. This approach applies to total scale and subscale scores.
Timepoint
one week after intervention.
Method of measurement
The data will be gathered by using questionnaire (PedRHDS form).
Secondary outcomes
empty
Intervention groups
1
Description
The intervention will involve conducting four face-to-face educational sessions with a duration of one hour for each session, that will be conducted every other day. The educational intervention will consists of providing information regarding the care for a pre-term new born after discharge( including Kangaroo Mother Care, feeding, safe sleeping positions, thermal care, bathing, diaper changing, vaccination, general hygiene, and follow-up clinics).
Category
Other
2
Description
Control group: The control group receive normal hospital routine (some information regarding the neonates feeding, and other consideration will be provided for parents during the discharge, in some cases this procedure maybe missed).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Muhimbili National Hospital
Full name of responsible person
Dr. Mehrnaz Geranmayeh
Street address
Tohid Square, Dr. Mirkhani St. ( eastern Nostrat
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 912 218 2811
Email
geranmay@tums.ac.ir
2
Recruitment center
Name of recruitment center
Mloganzila National Hospital in Tanzania, Africa
Full name of responsible person
Dr. Mehrnaz Geranmayeh
Street address
Tohid Square, Dr. Mirkhani St. (Eastern Nosrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 912 218 2811
Email
geranmay@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marzieh Hasanpour
Street address
Tohid Square, Dr. Mirkhani St. (East Nosrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4413
Email
m-hasanpour@sina.tums.ac.ir
Web page address
https://fnm.tums.ac.ir
Grant name
No grant
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Marzieh Hasanpour
Position
Supervisor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mirkhani St.; Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+9861054425
Email
m-hasanpour@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marzieh Hasanpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr. Mirkhani St. ( Eastern Nosrat); Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
m-hasanpour@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farshad Sharifi
Position
co-supervisor in statistics
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Dr. Mirkhani St. ( Eastern Nosrat); Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 912 201 4236
Fax
+98 21 8822 0085
Email
farshad.sharifi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available