Protocol summary

Summary
The aim of narrative writing effect on fathers’stress over the neonatal hospitalization in NICU is the purpose of this research.The approach of this research is the quasi-experimental of pre-test and after-test.The two groups of intervention and control complete the stress questionnaire on the first day. The intervention group complete the narrative writing, 3 times within 7 days, while the normal care is taken on control group. Lastly, the stress questionnaire is completed by both groups in the end of day 7 of neonatal hospitalization.

General information

Acronym
Neonatal Intensive Care Unit
IRCT registration information
IRCT registration number: IRCT201406045866N21
Registration date: 2014-07-19, 1393/04/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-07-19, 1393/04/28
Registrant information
Name
Akram Sanagoo
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1443 0360
Email address
sanagoo@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research & Technology, Golestan University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Narrative Writing on Fatherl Stress in Neonatal Intensive Care Settings
Public title
Writing emotion by fathers such as Story
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having an infant less than 37 gestational age; father age between 18-45 years old; having at least pre-high school education; not having another child with the history of hospitalization in the NICU; not having sick children at home; not having a severe stressful problem in the last 2 months; not having a history of psychedelic and drug use. Fathers’ exclusion criteria: lack of interest in participation in the research and infant’s death.
Age
From 18 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences,Shastkola
City
Gorgan
Postal code
4934174515
Approval date
2014-06-08, 1393/03/18
Ethics committee reference number
5620893031811

Health conditions studied

1

Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction

Primary outcomes

1

Description
Stress
Timepoint
First day after intervention and 7th day after intervention
Method of measurement
Standardized Mills questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: the first, the fathers in the intervention group will complete the Parental Stressor Scale on the 1rd day of the infant’s hospitalization. and then will ask to perform narrative writing at least three times until the end of the 7th day of the hospitalization, When they will ask again to complete the PSS questionnaire.
Category
Other

2

Description
control group : the fathers in the control group will complete the Parental Stressor Scale on the 1rd day of the infant’s hospitalization. Then, the fathers in the control group followe only the routine procedures of the NICU, and they were will ask to the end of the 7th day of the hospitalization, again to complete the PSS questionnaire.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Talghanii Hospital
Full name of responsible person
Negarin Akbari
Street address
Taleghani Street and Sayyad shirazi Street
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research & Technology, Golestan University of Medical Sciences
Full name of responsible person
Dr. Leila M Jouybari
Street address
Deputy of Research & Technology, Golestan University of Medical Sciences,Shastkola
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research & Technology, Golestan 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
Tehran University of Medical Science
Full name of responsible person
Negarin Akbari
Position
Ms Student of Critical Nursing Care
Other areas of specialty/work
Street address
Department of Neonatal Intensive Care Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
n-akbari@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing Research Center, Golestan University of Medical Sciences
Full name of responsible person
Leila M Jouybari
Position
PhD
Other areas of specialty/work
Street address
Golestan University of Medical Sciences, Shastkola Gorgan Golestan Iran, Islamic Republic Of
City
Gorgan
Postal code
Phone
+98 17 1443 0360
Fax
Email
Jouybari@gmail.com; Jouybari@goums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing Research Center, Golestan University of Medical Sciences
Full name of responsible person
Dr. Leila M Jouybari
Position
PhD of NUrsing Education, Dean of Nursing Research Center
Other areas of specialty/work
Street address
Nursing Research Center ,Golestan University of Medical Sciences,Shastkola
City
Gorgan
Postal code
Phone
+98 17 1443 0360
Fax
Email
Jouybari@gmail.com; Jouybari@goums.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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