Protocol summary

Summary
The aim of this research is study the effect of narrative writing on stress among patients famillies of intensive care units of Babol University of Medical Sciences. This is a single blinded clinical trail with before and after groups. One hundred and six patients famillies of intensive care unites of teaching hospitals affiliated to Babol University of Medical Services will participate in the study. Inclusion criteria are at least Age between 18- 65, At least secondary education, Absence of any other patient with a history of hospitalization in the intensive care unit, Absence of critically ill patients at home, Absence of acute stress problem in the last six months, Non-use of drugs associated with psychotic disorders in the past six months. The patients famillies will invite to attend in a orientation meeting to be informed about the process of research work. The intervention group will asked to write narrative one week. The data will collected with Depression Anxiety and Stress Scales (DASS-21) questionnaire before and after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016102930570N1
Registration date: 2017-01-27, 1395/11/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-27, 1395/11/08
Registrant information
Name
Hosein Bagherzadeh Sheshpol
Name of organization / entity
Golestan University of Merdical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
parhambagherzade@ymail.com
Recruitment status
Recruitment complete
Funding source
Deputy of Research & Technology, Golestan University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Narrative Writing On stress level Among patients famillies Of Intensive Care Units
Public title
The effect of narrative writing on hospitalized patients famillies stress in Intensive Care Units
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria :Age between 18- 65, At least secondary education, Absence of any other patient with a history of hospitalization in the intensive care unit, Absence of critically ill patients at home, Absence of acute stress problem in the last six months, Non-use of drugs associated with psychotic disorders in the past six months. exclusion criteria :Death of patient, Acute stress problems during the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 106
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
2016-03-09, 1394/12/19
Ethics committee reference number
IR.GOUMS.REC.1394.348

Health conditions studied

1

Description of health condition studied
Stress
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder

Primary outcomes

1

Description
Stress
Timepoint
Aweek
Method of measurement
DASS questionnaire

Secondary outcomes

1

Description
Anexity and Depression
Timepoint
A week
Method of measurement
DASS questionnaire

Intervention groups

1

Description
Intervention group: The participants will asked to write at least once a clinical narrative. They will receive a notebook which is designed for this purpose. They should write about their emotions, thoughts , the worse ethical experiences, the hard moments, the bad behaviors, clinical decisions.
Category
Rehabilitation

2

Description
Control group:Stress questionnaire completed by the participants on the first day and then again after one week .
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
SHahid Yahyanejad Teaching Hospital Babol University of Medical Sciences
Full name of responsible person
Hossein BagherZadeh
Street address
SHahid Yahyanejad Hospital ,Farhang Street
City
Babol

2

Recruitment center
Name of recruitment center
SHahid Beheshti Teaching Hospital Babol University of Medical Sciences
Full name of responsible person
Hosein Bagherzadeh SHeshpol
Street address
SHahid Beheshti Hospital , Ganj Afroz Street
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research & Technology, Golestan University of Medical Sciences
Full name of responsible person
Dr Masood Khoshnya
Street address
Deputy of Research & Technology, Golestan University of Medical Sciences , Shastkola Gorgan
City
Gorgan
Grant name
313863/348
Grant code / Reference number
456456
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
Golestan University of Medical Sciences
Full name of responsible person
Hosein Bagherzadeh Sheshpol
Position
Ms Student of Critical Nursing Care
Other areas of specialty/work
Street address
Bouyeh School of Nursing & Midwifery, Golestan University of Medical Sciences , Shastkola
City
Gorgan
Postal code
4934174515
Phone
+98 11 3219 2443
Fax
+98 32421657
Email
parhambagherzade@ymail.com
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
Dr Leila M Jouybar
Position
PhD, Dean of Nursing Rsearch Center
Other areas of specialty/work
Street address
Golestan University of Medical Sciences , Shastkola
City
Gorgan
Postal code
49165568
Phone
+98 17 3243 0360
Fax
+98 32421657
Email
Jouybari@gmail.com ; Jouybari@goums.ac.ir
Web page address
Jouybarigoums.ac.ir

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
49165568
Phone
+98 17 3243 0360
Fax
+98 32421657
Email
Jouybari@gmail.com ; Jouybari@goums.ac.ir
Web page address
Jouybarigoums.ac.ir

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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