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The effect of family-centered care on the amount of stress, anxiety and depression of mothers of premature infants hospitalized in the Neonatal Intensive Care Unit (NICU)

Protocol summary

Summary
The research is a quasi-experimental research. Research samples include 80 mothers with hospitalized premature infants selected by the gradual sampling method and placed in control and experiment groups. First, samples of the control group are selected. In the first step of family-centered cares, researchers get familiar with nurses and environment and the rest of family-centered care is done in the following three steps with the presence of researcher and mother: 1) At the beginning of taking care of infant by mother, 2) before the fourth day of hospitalization and 3) before the discharge of infant in presence of mother. In the first step, information is provided relating to appearance, behavior, sleep and wakefulness patterns, stress symptoms in infants, and mothers' role in taking care of premature infants. In the second step, the best interaction time with the infant, methods of taking care of premature infants, nutrition, bathing, maintaining the body temperature and taking care of the umbilical cord are provided to mothers. In the final step, the role of mothers in transferring infants from the hospital to house, effective relationship with infants, emphasis on the screening test of vaccination, medicines, and method of communicating with infants are addressed. In order to determine the effect of family-centered care on depression, anxiety and stress of mothers, DASS-21 scale is used at the beginning of mothers' taking care of infants, 4 days after the beginning of intervention and at the day of discharge 1) At the beginning of taking care of infant by mother, 2) before the fourth day of hospitalization and 3) before the discharge of infant with the presence of mother. In the first step, information is provided relating to appearance, behavior, sleep and wakefulness patterns, stress symptoms in infants, and mothers' role in taking care of premature infants. In the second step, the best interaction time with the infant, methods of taking care of premature infants, nutrition, bathing, maintaining the body temperature and taking care of the umbilical cord are provided to mothers. In the final step, the role of mothers in transferring infants from the hospital to house, effective relationship with infants, emphasis on the screening test of vaccination, medicines, and method of communicating with infants are addressed. In order to determine the effect of family-centered care on depression, anxiety and stress of mothers, DASS-21 scale is used at the beginning of mothers' taking care of infants, 4 days after the beginning of intervention and at the day of discharge by mothers

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015012212990N6
Registration date: 2015-02-14, 1393/11/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-02-14, 1393/11/25
Registrant information
Name
Minoo Mitra Cherhzad
Name of organization / entity
Guilan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 13 1555 5056
Email address
chehrzad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology, Guilan University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered care on the amount of stress, anxiety and depression of mothers of premature infants hospitalized in the Neonatal Intensive Care Unit (NICU)
Public title
The effect of family-centered care on the amount of stress, anxiety and depression of mothers of premature infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria for infants:Gestational age of 28 to 35 weeks, birth weight of less than 2500 g, being a single infant and lack of congenital malformations Inclusion criteria for mothers: Age more than 18 years, literacy, predominance in Persian language, not having an infant hospitalized in NICU before, lack of the experience of taking care of a premature infant, lack of a physical illness disturbing daily activities and lack of obvious neurological and psychiatric problems leading to take medicine.
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Samples of the control and experiment groups are homogenized in terms of some personal characteristics such as mother's age, mother's education, family's income and infant's birth rate

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences Ethics Committee
Street address
Deputy of Research and Technolog of University of Guilan, Iran Radiator, Imam Khomeini Blv, Rasht
City
Rasht
Postal code
Approval date
2014-12-30, 1393/10/09
Ethics committee reference number
2930459716

Health conditions studied

1

Description of health condition studied
Stress, Anxiety and Depression of mothers of premature infants
ICD-10 code
V- F43.9 ,
ICD-10 code description
Mental and behavioural disorders

Primary outcomes

1

Description
Stress , Anxiety and Depression
Timepoint
Before intervention , four days after the beginning of the intervention and during the hospital discharge after the last stage of intervention
Method of measurement
DASS-21 scale of stress, anxiety and depression

Secondary outcomes

empty

Intervention groups

1

Description
In the first step of family-centered care, the experiment group will get familiar with nurses, environment, facilities, equipment and unit's rule by the researcher and the rest of family-centered care is done in the following three steps with the presence of researcher and mother: 1) At the beginning of taking care of infant by the mother, 2) before the fourth day of hospitalization and 3) before the discharge of infant with the physical presence of mother for taking care of the infant. At any step lasting for one to two hours, first cares are taken by the researcher at the presence of the mother and the feedback is received by the mother. In addition, at the beginning of taking care of the infant by mother, the instructional booklet of family-centered care is provided to parents.
Category
Prevention

2

Description
The control group received usual care
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
17 Shahrivar And Alzahra Remedial Education Centers
Full name of responsible person
Solmaz Pourkhani
Street address
Namjoo Street,Gaz Square,Rasht
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research and Technology, Guilan University of Medical Sciences
Full name of responsible person
Doctor Abtin Heidarzadeh
Street address
Deputy of Research and Technolog of University of Guilan, Iran Radiator, Imam Khomeini Blv, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Guilan University of Medical Sciences
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
Guilan University of Medical Sciences
Full name of responsible person
Solmaz Pourkhani
Position
Bachelor's Degree in Nursing-Nurse
Other areas of specialty/work
Street address
Razi remedial education Center
City
Rasht
Postal code
Phone
+98 13 3312 9550
Fax
Email
Sogandbosari@YAHOO.COM
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Minoo Mitra Chehrzad
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Shahid Beheshti Nursing And Midwifery Faculty of Rasht
City
Rasht
Postal code
Phone
+98 13 3355 5056
Fax
Email
chehrzad@gums.ac.ir; mchehrzad@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Solmaz Pourkhani
Position
Bachelor's Degree in Nursing-Nurse
Other areas of specialty/work
Street address
Razi remidial education center
City
Rasht
Postal code
Phone
+98 13 3312 9550
Fax
Email
SOGANDBOSARI@YAHOO.COM
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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