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The effect of the educational program on Iranian premature infants' parental stress in neonatal intensive care unit: A double-blind randomized controlled trial.

Protocol summary

Summary
Birth is one of the important events in the life of each parent and if this matter, since beginning, requires hospitalization in NICU which is full of equipment, tools and supplies and it is noisy, it will put a lot of stress and shock to the parents. As long as the nurses are the primary sources of information to parents and they play a very important role in reducing their stress, we decided to determine the effect of education on the parental stress of the premature infants hospitalized in NICU. Inclusion criteria: 1) age greater than 18 years, 2) mastered in the Persian language and reading and writing ability, 3) a minimum of 1 times to meet the baby and had seen the NICU. Exclusion criteria: 1) The parents want to leave the study, 2) The parents did not participate all of the educational meeting, 3) The parents had another stressor factors moreover than inclusion criteria. Population of study: All of the parents of premature infants that admission in a Neonatal Intensive Care Unit in one of the Hospitals Related to Shiraz University of Medical Sciences. Environmental study: Neonatal Intensive Care Unit in one of the Hospitals Related to Shiraz University of Medical Sciences. In this study, the researcher, attending the Research Environment, selects her samples from the parents of hospitalized infants eligible for inclusion in the study and measured parental stress at three steps: second day after admission, and after intervention and one week after end of intervention, then measured parental stress average numbers in that 3 steps and compared with the same number in control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013121515810N1
Registration date: 2014-07-05, 1393/04/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-05, 1393/04/14
Registrant information
Name
Seyedeh Marzieh Baharlu
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4257
Email address
baharlu_m@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the educational program on Iranian premature infants' parental stress in neonatal intensive care unit: A double-blind randomized controlled trial.
Public title
The effect of the educational program on Iranian premature infants' parental stress in neonatal intensive care unit: A double-blind randomized controlled trial.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1) age greater than 18 years, 2) mastered in the Persian language and reading and writing ability, 3) a minimum of 1 times to meet the baby and had seen the NICU, 4) during the past year they didn’t have the previous experience stressors, 5) they didn’t have the previous precedent of a child had been hospitalized in the neonatal intensive care unit, 6) according to their own statements they were not being treated with certain medications such as tranquilizers, anti-anxiety, 7) according to their own statements they didn’t have physical or mental problems which interfere the participation in the study and completion the questionnaire used in the study, 8) during participation in curriculum they were not participate in another program or intervention, 9) they were not one of the medical staff, 10) they were willing to participate in the study in addition they completed a consent form. Exclusion criteria: 1) The parents want to leave the study, 2) The parents did not participate all of the educational meeting, 3) The parents had another stressor factors moreover than inclusion criteria.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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 Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Postal code
Approval date
2013-12-08, 1392/09/17
Ethics committee reference number
926605

Health conditions studied

1

Description of health condition studied
Parental Stress Parameters
ICD-10 code
Z00,Z01,Z0
ICD-10 code description
عوامل مؤثر بر اوضاع سلامتی و مرتبط با خدمات سلامت

Primary outcomes

1

Description
Stress
Timepoint
2days after admition,after intervention,1week after intervention
Method of measurement
Parental Stress Scale

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: Parents in the intervention group during four 45-minute sessions of face to face training in a hospital conference room and the baby's bedside are trained by the researcher
Category
Prevention

2

Description
control group: Parents in the control group did not receive any training of researcher and only in times of stress test similar to the intervention group evaluate their stress.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Zeinabyeh Hospital
Full name of responsible person
Seyedeh Marzieh Baharlu
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
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, shiraz 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
Shiraz University of Medical Sciences, Hazrate Fatemeh Nursing and Midwifery Faculty
Full name of responsible person
Seyedeh Marzieh Baharlu
Position
Neonatal Intensive Care Nursing Master of Science Student
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery Faculty, Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4257
Fax
Email
Baharlu_m@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences , Hazrate Fatemeh Nursing and Midwifery Faculty
Full name of responsible person
Nooshin Beheshtipour
Position
Pediatric Nursing MS,Faculty member
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery Faculty, Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4257
Fax
Email
Beheshti64@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyedeh Marzieh Baharlu
Position
Neonatal Intensive Care Nursing Master of Science Student
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery Faculty, Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
00
Fax
Email
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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