Protocol summary

Study aim
The main objective: determining the effect of written / spoken exposition on depression, anxiety and stress. Specific purpose: comparison of anxiety and stress depression in patients immediately, one week and one month after the beginning of the study in four groups.
Design
100 patients are randomly assigned to quadruple blocks in four groups of 25.
Settings and conduct
The open heart surgery departments of Amiralmomenin Kurdoki Hospital are the place of study. Double blind study.
Participants/Inclusion and exclusion criteria
Research samples are open-heart hospital post-operative patients. Conditions for inclusion to study: lack of mental illness; non-use of drugs. Exclusion criteria: disclose less than three times in the emotional disclosure group or having readmission during the study.
Intervention groups
Intervention: four to ten minutes to expose 10-15 minutes of written / spoken emotional excitement. Study groups: two groups of Intervention and two control groups. Intervention group one: negative emotional disclosure. Intervention group Two: Positive emotional disclosure. Control group one: Neutral emotional disclosure. Control group two: no action is taken.
Main outcome variables
Depression; anxiety; stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110219005866N29
Registration date: 2018-10-27, 1397/08/05
Registration timing: retrospective

Last update: 2018-10-27, 1397/08/05
Update count: 0
Registration date
2018-10-27, 1397/08/05
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
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
2018-06-22, 1397/04/01
Actual recruitment end date
2018-09-21, 1397/06/30
Trial completion date
2018-09-21, 1397/06/30
Scientific title
The Effect of Written / Speech Expression on Depression, Anxiety and Stress in Patients After Open-Heart Surgery Amiralmomenin Kordkuy Hospital
Public title
Effect of Written / Speech Expression on Depression, Anxiety and Stress
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No use of psychoactive drugs No addiction
Exclusion criteria:
Patients for any reason continue to participate in the study at the time of study Patients with less than three exposures in the emotional exacerbation group are excluded Patients re-admitted to the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Actual sample size reached: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Four random block assignments were assigned to the groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Executable Examiner; Information Analyzer
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Gorgan،Golestan University of Medical Sciences
City
Gorgan
Province
Golestan
Postal code
49341-74515
Approval date
2018-07-15, 1397/04/24
Ethics committee reference number
IR.GOUMS.REC.1397.073

Health conditions studied

1

Description of health condition studied
Coronary heart disease
ICD-10 code
125.0
ICD-10 code description
Coronary heart disease

Primary outcomes

1

Description
Depression
Timepoint
Come to study, one week later, one month after the study
Method of measurement
DASS-21 questionnaire (depression, anxiety, stress)

2

Description
stress
Timepoint
Come to study, one week later, one month after the study
Method of measurement
DASS-21 questionnaire (depression, anxiety, stress)

3

Description
Anxiety
Timepoint
Come to study, one week later, one month after the study
Method of measurement
DASS-21 questionnaire (depression, anxiety, stress)

Secondary outcomes

empty

Intervention groups

1

Description
Two intervention groups: intervention group one, negative emotional disclosure, intervention group two, positive emotional disclosure
Category
Behavior

2

Description
Control group: two groups of control, control of neutral excitement and control group two, routine care
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan University of Medical Scinses
Full name of responsible person
Akram Sanagoo
Street address
Shast Kola Road
City
Gorgan
Province
Golestan
Postal code
49165-568
Phone
+98 17 3245 1360
Fax
+98 17 3242 5171
Email
a_sanagu@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Honarvar
Street address
Shast kola
City
Gorgan
Province
Golestan
Postal code
49341-74515
Phone
+98 17 3242 1660
Fax
+98 17 2345 6778
Email
honarvar@goums.ac.ir
Web page address
http://goums.ac.ir/
Grant name
Deputy of Research and Technology of Golestan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Akram sanagoo
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shast kola
City
Gorgan
Province
Golestan
Postal code
49341-74522
Phone
+98 17 3245 1360
Fax
+98 17 3245 5171
Email
a_sanagu@yahoo.com
Web page address
http://goums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
َAkram Sanagoo
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shast kola
City
Gorgan
Province
Golestan
Postal code
49341-74522
Phone
+98 17 3245 1360
Fax
+98 17 3245 5171
Email
a_sanagu@yahoo.com
Web page address
http://goums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Akram Sanagoo
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shast kola
City
Gorgan
Province
Golestan
Postal code
49341-74522
Phone
+98 17 3245 1360
Fax
+98 17 3245 5171
Email
a_sanagu@yahoo.com
Web page address
http://goums.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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