Determining the effect of educational program on the stress of mothers of infants admitted to the neonatal intensive care unit
Design
In this study, 62 mothers of infants admitted to the neonatal intensive care unit will be selected based on entry criteria and the subjects will be randomly assigned into two groups of test and control and each person is assigned a code.
Settings and conduct
This research will be carried out in the neonatal intensive care unit of Vali-e-Asr Hospital in Birjand. After examining the criteria for entering the mothers, they will be divided into two groups of control and intervention and the Parent-Miles and Funk Tests Questionnaire before and one The weeks after the intervention will be completed for the two groups
Participants/Inclusion and exclusion criteria
Mothers of infants weighing less than 2500 grams and immature (uterine age less than 37 weeks)
Intervention groups
The control group will receive no training
The intervention group includes an instructional program for handwashing and infective control during contact with the baby, appropriate infant formula, proper physical conditions for the baby in the premature infant, nutrition from the stomach tube, and the teaching of breastfeeding, a suitable measure for weight gain, infant bathing Will receive the importance of hugging and touching the baby and explaining the equipment used for the baby and the condition of breathing and his appearance.
Main outcome variables
Maternal stress score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170902036026N4
Registration date:2018-02-01, 1396/11/12
Registration timing:retrospective
Last update:2018-02-01, 1396/11/12
Update count:0
Registration date
2018-02-01, 1396/11/12
Registrant information
Name
Fatemeh Taheri
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3245 0499
Email address
f.taheri@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Birjand University of Medical Sciences
Expected recruitment start date
2017-05-26, 1396/03/05
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
2017-05-26, 1396/03/05
Actual recruitment end date
2017-08-21, 1396/05/30
Trial completion date
empty
Scientific title
Clinical trial the effect of educational program on the stress of mothers of premature infants
Public title
The effect of educational program on the stress of mothers of premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers of infants weighing less than 2500 grams that are immature (uterine age less than 37 weeks)
The mother has literacy to read and write
Exclusion criteria:
The baby has no abnormalities
Premature birth of a premature baby
No history of depression or anxiety
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
62
Actual sample size reached:
62
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghaffari Street, Birjand
City
Birjand
Province
South Khorasan
Postal code
9718863388
Approval date
2017-05-07, 1396/02/17
Ethics committee reference number
ir.bums.REC.1395272
Health conditions studied
1
Description of health condition studied
Estress
ICD-10 code
F43.0
ICD-10 code description
Psychological disorders, stress disorders and physical disorders
Primary outcomes
1
Description
Maternal stress
Timepoint
Before intervention and 10 days after intervention
Method of measurement
Parent-Miles Stress Questionnaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: with presence of the mother on the infant's bedside, samples will receive face to face training and practical presentation with practice and repeat in the presence of a researcher during every day 30 to 45 for 3 days, giving minutes and video presentation (45 to 60 minutes). The booklet will be available for participants for reviewing the materials .
Category
Behavior
2
Description
Control group: No intervention will be received
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal Intensive Care Unit
Full name of responsible person
Ms. Parhiz, Nursing Head-Nurse
Street address
Vali Asr Hospital, Birjand
City
Birjand
Province
South Khorasan
Postal code
9718863388
Email
f.taheri@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Birjand University of Medical Sciences
Full name of responsible person
Kazemi Tuba
Street address
Research & Technology Dept, Third Floor, Education and Research Building, University of Medical Sciences, Birjand
City
Birjand
Province
South Khorasan
Postal code
9718863388
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Birjand 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
Valiasr Hospital
Full name of responsible person
Fatemeh Taheri
Position
Nurs
Latest degree
Master
Other areas of specialty/work
Street address
Vali Asr Hospital, Ghafari St, Birjand
City
Birjand
Province
South Khorasan
Postal code
9718863388
Phone
+98 56 3245 0499
Fax
Email
f.taheri@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vali Asr Hospital
Full name of responsible person
Fatemeh Taheri
Position
Nursing expert
Latest degree
Master
Other areas of specialty/work
Street address
Plaques 69, Tohid 7, Birjand
City
Birjand
Province
South Khorasan
Postal code
9718863388
Phone
+98 56 3245 0499
Fax
Email
f.taheri@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Taheri Fatemeh
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghaffari Street,Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9718863388
Phone
+98 56 3245 0499
Email
f.taheri@bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data for the original outcome is shared
When the data will become available and for how long
One year after the publication of the results
To whom data/document is available
Researchers of academic institutions
Under which criteria data/document could be used
Any analysis on the data is not allowed and is provided only to guide the researchers
From where data/document is obtainable
f.taheri@bums.ac.ir fateme taheri
What processes are involved for a request to access data/document
The researcher will have access to the data once the data is correct, after providing his or her profile and university at work or education, and providing evidence of non-misuse of data.