Protocol summary

Summary
Our goal was to study the effects of premature infant's parent empowerment program in NICU, as a family centered intervention, on their involvement, stress and beliefs. A quasi-experimental, posttest-only design with a comparison group was conducted with 65 families with preterm infants from 2010 to 2011 in NICUs and high risk neonate units in two Hospitals of Tehran University of Medical Science. Parents in experiment group received information and behavioral activities about the appearance and behavioral characteristics of preterm infants and how best to parent them via verbal face to face education, audio taped in CD or Bluetooth and written materials.Both fathers and mothers in the empowerment program group were more involved in their infants’ care, and reported significantly less stress in the NICU, as well as, higher beliefs about their parental role and what behaviors and characteristics to expect of their infants during hospitalization, compared with control parents. So, Parent empowerment program can involve parents in their infants’ care and reduce parenting stress among both mothers and fathers of preterm infants and improves their beliefs about parental role and what behaviors and characteristics to expect of their infants in NICU.

General information

Acronym
Parental Empowerment Program
IRCT registration information
IRCT registration number: IRCT138904234372N1
Registration date: 2011-02-24, 1389/12/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-02-24, 1389/12/05
Registrant information
Name
Roghieh Karimi
Name of organization / entity
Nursing School of Tehran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 7120
Email address
karimirg@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical science
Expected recruitment start date
2010-06-05, 1389/03/15
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of premature infant's parent empowerment program in NICU, on their involvement, stress and beliefs in Hospitals of Tehran University of Medical Science.
Public title
Parental Empowerment Program, on their Involvement, Stress & Beliefs
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: All mothers and fathers were above 18 years of age, who could read and speak persian, and did not consume antianxiety drugs, Whitout stressful event in family, And whose infants born at the study sites, below 37 weeks of gestational age and singelton birth. exclusion criteria:situation that cause Neonatal death.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 65
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Review Committee of Tehran University of Medical Sciences
Street address
Floor 6, Central Building of Tehran University ,Intersection of Ghods & Keshavarz Blv.
City
Tehran
Postal code
Approval date
2010-01-05, 1388/10/15
Ethics committee reference number
433/130/د/89

Health conditions studied

1

Description of health condition studied
parental Stress
ICD-10 code
Z75.8
ICD-10 code description
Other problems related to medical facilities and other health care

2

Description of health condition studied
Parental Involvement
ICD-10 code
Z76.3
ICD-10 code description
Healthy person accompanying sick person

3

Description of health condition studied
parental Belief
ICD-10 code
Z63.9
ICD-10 code description
Problem related to primary support group, unspecified

Primary outcomes

1

Description
parental Involvement in neonatal care in NICU
Timepoint
1-2 day before discharge
Method of measurement
Observational check list of parental involvement in neonatal care in NICU

2

Description
parental Beliefs in NICU
Timepoint
1-2 day before discharge
Method of measurement
parental Beliefs Scale in NICU (PBS:NICU)

3

Description
parental stress in NICU
Timepoint
1-2 day before discharge
Method of measurement
parental stress Scale in NICU (PSS:NICU)

Secondary outcomes

empty

Intervention groups

1

Description
Parents in experiment group received parental empowerment program that contains information and behavioral activities about the appearance and behavioral characteristics of preterm infants and how best to parent them via verbal face to face education, audio taped in CD or Bluetooth and written materials.
Category
Behavior

2

Description
in admission, hospitalize & discharge time standard care done for both control & intervention group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Mirza kuchak khan Hospital
Full name of responsible person
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
Valie Asr Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for research of tehran university of medical science
Full name of responsible person
Dr. Yunesiyan
Street address
floor 6, central bulding of university , Ghods, Keshavarz Blv.
City
Tehran
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 of tehran university of medical science
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
nursing school of tehran university of medical science
Full name of responsible person
Mahboobeh Khajeh
Position
Master of Science in nursing
Other areas of specialty/work
Street address
Nosrat street, East side of Tohid sq.
City
Tehran
Postal code
Phone
+98 912 373 2434
Fax
Email
mkhajeh@tums.ac.ir; m_khajeh@ymail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
nursing school of tehran university of medical science
Full name of responsible person
Roghieh Karimi
Position
Master of Science in nursing/faculty member
Other areas of specialty/work
Street address
Nosrat street, East side of Tohid sq.
City
Tehran
Postal code
Phone
+98 21 6692 2700
Fax
Email
karimirg@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Mahboobeh Khajeh
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
mkhajeh@tums.ac.ir
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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