the effect of early interventions with telemedicine on the development of premature babies and the self-efficacy of their parents in the corona pandemic
Determining the impact of timely interventions through distance education on the development process of premature babies and their parents' self-efficacy
Community Verified icon
Design
The clinical trial has two control and intervention groups, double-blind, randomized and is conducted on 32 patients.
Settings and conduct
Available samples from newborns admitted to the NICU department of Imam Hossein and Mahdieh Hospital in Tehran
Participants/Inclusion and exclusion criteria
Birth at 30 to 36 weeks of pregnancy 2- Baby weighing more than 1500 gr 3- Parents' ability to read and write and master Persian language 4-Having a smart mobile phone and relative familiarity with virtual systems and social networks Community Verified icon
Intervention groups
30 to 37 weeks premature babies hospitalized in the nicu department of Imam Hossein and Mahdieh Hospital in Tehran
Main outcome variables
Parental self-efficacy, newborn development, questionnaire for measuring knowledge-attitude-performance of mothers of premature babies
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220725055554N1
Registration date:2022-12-27, 1401/10/06
Registration timing:prospective
Last update:2022-12-27, 1401/10/06
Update count:0
Registration date
2022-12-27, 1401/10/06
Registrant information
Name
zahra amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8824 3160
Email address
zahra.mini75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-06, 1401/10/16
Expected recruitment end date
2023-04-18, 1402/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of early interventions with telemedicine on the development of premature babies and the self-efficacy of their parents in the corona pandemic
Public title
tele-education on premature's parents
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1-birthday 30 to 36 weeks of pregnancy
2- Baby weighing more than 1500 gr
3- Parents' ability to read and write and master Persian language
4-Having a smart mobile phone and relative familiarity with virtual systems and social networks
Exclusion criteria:
-Severe brain damage or congenital anomalies according to the medical record
2- Baby feet
3- Hospitalization in NICU for less than a week or more than a month
4-Apgar score lower than 7
5- IVH grade 3 or 4
6- Babies without a guardian or a single parent
7-Severe malaise of mother and baby
8-Addicted or alcoholic parents
Age
From 210 days old to 259 days old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation to two intervention and control groups is done in a simple random manner and in the form of alternating stratified blocks.That is, 4 samples with similar demographic information written in English letters and all possible permutations for placement Community Verified icon In the intervention or control group, it is written on separate pieces of paper, then a permutation is selected from among the papers randomly and by lottery. The first 2 samples will be in the intervention group and the next two samples will be in the control group. According to the week of birth, the samples are matched in two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Bailey's face-to-face test will be conducted by a foreign trainer without knowledge of the treatment groups. The participants were unaware of the purpose of the study and allocation to the groups. The data analyst will be a statistical consultant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice President of Research and Technology Shahid Beheshti University of Medical Sciences
Street address
gisha
City
tehran
Province
Tehran
Postal code
1651139969
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.569
Health conditions studied
1
Description of health condition studied
prematurity
ICD-10 code
I49.4
ICD-10 code description
Other and unspecified premature depolarization
Primary outcomes
1
Description
Parental self-efficacy
Timepoint
At the beginning of the study and 3 months after that
At the beginning of the study and 3 months after that
Method of measurement
bayley and ASQ (age and stages questionnaire)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group 3 months of free distance Includes videos, photos, videos and educational images prepared based on the MITP (mother infant transaction) program and hug care training.education on how to care for and develop premature babies.3 months and 6 training sessions will be held every other week.
Category
Rehabilitation
2
Description
Control group: The control group is a group that does not receive training during 3 months and only benefits from the routine interventions of the hospital. It only completes the primary and secondary questionnaires.Community Verified icon
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Zahra Amini
Street address
Madani
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
info@ehmc.ir
2
Recruitment center
Name of recruitment center
Mahdiyeh Hospital
Full name of responsible person
Zahra Amini
Street address
Shisheh Gar
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Sadigheh Naiemi
Street address
Gisha
City
Tehran
Province
Tehran
Postal code
1651139969
Phone
+98 21 23871
Fax
Email
zahra.mini75@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
1
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Amini
Position
Occupational Therapist
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Gisha
City
Tehran
Province
Tehran
Postal code
1561139969
Phone
+98 21 8824 3160
Email
zahra.mini75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Amini
Position
Occupationl Therapist
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Gisha
City
Tehran
Province
Tehran
Postal code
1561139969
Phone
+98 21 8824 3160
Email
zahra.mini75@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Amini
Position
Occupational Therapist
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Gisha
City
Tehran
Province
Tehran
Postal code
1561139969
Phone
+98 21 8824 3160
Email
zahra.mini75@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
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
It is published at the discretion of the respective professors
When the data will become available and for how long
6 months later
To whom data/document is available
Students
Under which criteria data/document could be used
----
From where data/document is obtainable
------
What processes are involved for a request to access data/document