Protocol summary

Summary
Objectives: To determine the effect of poetry therapy of anxiety in patients with, Myocardial Infarction. Design: The study is a Clinical Tria.l Setting and conduct: Poetry sessions for each patient individually and for four sessions per week and each session takes about 45 minutes for each person carried. Participants including major eligibility criteria: 60 Patients with a heart attack suffered moderate anxiety. Interventions: Reading poetry approved for patients that have been collected in a book. Variables: poetry therapy, Moderate anxiety, Heart attack.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015082412830N4
Registration date: 2015-10-04, 1394/07/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-04, 1394/07/12
Registrant information
Name
Faezeh Jahanpour
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1455 0187
Email address
f.jahanpour@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Bushehr University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Poetry Therapy On the level of the anxiety in Patients With Myocardial Infarction in Boushehr Heart Hospital in 1394.
Public title
The Effect of Poetry Therapy On the level of the anxiety in Patients With Myocardial Infarction in Boushehr Heart Hospital in 1394.
Purpose
Treatment
Inclusion/Exclusion criteria
Criteria for inclusion of patients in the study included coronary heart disease diagnosis by a physician, as well as having mild to moderate anxiety. Exclusion criteria included the following: 1. Patients with large myocardial infarction 2. History of heart disease and hospitalization in ICU and CCU 3. Hemodynamically unstable 4. History of seizures 5. Deaf 6. The primary school 8. The non-Persian speaking 9. Older than 65 years 10. Drug addiction
Age
From 74 years old to 29 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Bushehr University of Medical Sciences
Street address
No. 12, Bahmani, Yasini Avenue,Bushehr University of Medical Sciences Campus, Iran, Bushehr
City
Bushehr
Postal code
7514633341
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
Bpums.res.1394.15

Health conditions studied

1

Description of health condition studied
Acute Myoccardial Infarction
ICD-10 code
I21
ICD-10 code description
Myocardial infarction specified as acute or with a stated duration of 4 weeks (28 days) or less from onset

Primary outcomes

1

Description
Anexity
Timepoint
Pre test, Post test
Method of measurement
Beck Anxiety Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Poetry therapy in case group
Category
Behavior

2

Description
Placebo in the control group
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Heart Hospital of Bushehr
Full name of responsible person
Dr Amir Abbasi
Street address
NO 7, Intersection Justice St, Heart Hospital of Bushehr, Bushehr
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,bushehr University of Medical Sciences
Full name of responsible person
Afshin Ostavar
Street address
NO 12, Campus of Medical Sciences,Bahamni, Yasini Avenue, Bushehr
City
Bushehr
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,bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Faeze Jahanpoor
Position
PhD in Nursing / Associate Professor
Other areas of specialty/work
Street address
NO 7, School of Nursing and Midwifery,Bahmani, Yasini st, Bushehr
City
Bushehr
Postal code
7514633341
Phone
+98 774550187
Fax
Email
F.Jahanpour@Bpums.Ac.Ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
NO 31, Bushehr University of Medical Sciences
Full name of responsible person
Darush Iranpoor
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Medicine, Bushehr University of Medical Sciences, a crossroads of Justice st, Bushehr,
City
Bushehr
Postal code
7517933755
Phone
+98 77 1252 0657
Fax
Email
Iranpoor@Bpums.Ac.Ir
Web page address

Person responsible for updating data

Contact

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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