The aim of the study:
The effect of family-centered intervention based on verbal communication and stress coping mechanisms (coping) neonates admitted to the neonatal intensive care unit
Type of study:
This study is a quasi-experimental study with two groups
Research environment:
Neonatal intensive care unit of a hospital affiliated with the Hamadan University of Medical Sciences
Research community:
All mothers of infants in the neonatal intensive care unit with age greater than 33 weeks
Sampling:
The availability and use of neonates admitted to the neonatal intensive care unit and is based on the inclusion criteria.
Entry criteria:
- Age over 18 years old.
- Member of the healthcare team may not.
- Top 33 week old baby.
Exclusion criteria:
Unwillingness to participate in research or tired mother or infant death
Sample size:
Test and control groups of 50 each.
The intervention:
Intervention Family-based intervention based on verbal communication with mothers of infants admitted to the NICU nurses in the study and control groups will perform.This form of communication and education to mothers in the intervention groups with mothers who will take delivery of the package (within 4 days). The control group will support the routine.
On the fourth day of the questionnaire is completed parenting stress and coping mechanisms (in both groups) and the results of the questionnaires in both groups compared.
General information
Acronym
NICU(neonatal intensive care unit)
IRCT registration information
IRCT registration number:IRCT201104276316N1
Registration date:2015-03-07, 1393/12/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-07, 1393/12/16
Registrant information
Name
Zahra Daneshvar Ameri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
daneshvz@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-02-08, 1393/11/19
Expected recruitment end date
2015-03-01, 1393/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of family-based intervention on stress and coping mechanisms (coping) neonates admitted to the neonatal intensive care unit (NICU).
Public title
Effects of family-based intervention on stress and coping mechanisms (coping) neonates admitted to the neonatal intensive care unit (NICU).
Purpose
Supportive
Inclusion/Exclusion criteria
Mothers inclusion criteria included the following:
1- Willingness to cooperate.
2- 24 to 48 hours after admission to the baby arrives.
3- Maternal age over 18 years old.
4- The absence of stressful events during the intervention in the family, including children who have a serious illness.
5- No truce with husband.
6- Able to read and write Persian.
7- Member of the healthcare team may not.
8- Avoid the use of anti-anxiety medication.
9- Types of drug addiction is not.
10- Children age greater than 33 weeks.
11- Absence of congenital anomalies of the nervous system disease in infants.
Mothers Exclusion criterion:
1- Unwillingness to participate in research or tired mother or infant death.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
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
Tehran University of Medical Sciences, School of Nursing and Midwifery
Street address
Tehran - tohid Square
City
tehran
Postal code
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
9011451008-1
Health conditions studied
1
Description of health condition studied
Stress and coping mechanisms
ICD-10 code
F40- 48
ICD-10 code description
Neurotic, stress-related and somatoform disorders
Primary outcomes
1
Description
Coping Mechanisms
Timepoint
On the first and fourth
Method of measurement
Lazarus and Folkman's coping mechanisms questionnaire
2
Description
stress
Timepoint
On the first and fourth days
Method of measurement
Parental Stress Inventory doctor Miles
Secondary outcomes
empty
Intervention groups
1
Description
Control group:
Written consent signed by the mother and demographic data sheet ,parental stress questionnaire and coping mechanisms questionnaire on the first day and again on the fourth day will be completed .
Category
Behavior
2
Description
Group test:
Mothers after signing informed consent, demographic data sheet,Parental Stress Inventory questionnaire completed adaptation mechanisms and more about the environment, laws, contact phone numbers and information necessary to receive primary and a complete package including all the things that might be controversial for mothers question (the physical space, the physician or physicians baby, named for the section, the baby care, baby pipes connected to the equipment, meeting times, how breastfeeding baby, hold the baby, etc.) are delivered. In the second and third days, the hours designated by the mothers regularly, at least twice a day for half an hour each time and information to meet the psychological needs of mothers will be discussed. On the fourth day, questionnaires completed by mothers of stress and coping mechanisms.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan University of Medical Sciences
Full name of responsible person
Tahereh Sattari
Street address
Hamadan - Fatemiyeh Hospital & Beasat Hospital
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences-Research Administration
Full name of responsible person
Dr. Taghizadeh
Street address
Tehran - Faculty of Nursing and Midwifery
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences-Research Administration
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Zahra Daneshvar Ameri
Position
Faculty member
Other areas of specialty/work
Street address
Tehran - School of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
daneshvz@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University
Full name of responsible person
Zahra Daneshvar Ameri
Position
Faculty member
Other areas of specialty/work
Street address
Tehran, TUMS School of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
daneshvz@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Tahereh Sattari
Position
Graduate student at the neonatal intensive care
Other areas of specialty/work
Street address
Tehran - Touhid Square - School of Nursing and Midwifery
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
daneshvz@sina.tums.ac.ir; hsattary@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)