Protocol summary

Summary
This is a randomized controlled trial. Whit aim to compare the effect of education through three methods of face to face, multimedia CD and Text messaging on anxiety and vital sign of patients undergoing exercise test In selected Hospitals of Larestan regional in 2017.150 heart disease patients whose exercise test had the characteristics of the study, were randomly assigned into three groups. Collection tools is included demographic questionnaire and Beck Anxiety Inventory. Patients receive routine care in control group and Interactive multimedia CD in the experimental 1 group and SMS before and one week after receiving the necessary training in experimental 2 group. Beck Anxiety Inventory questionnaire before intervention and one week after the intervention will be completed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017042933689N1
Registration date: 2017-08-20, 1396/05/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-08-20, 1396/05/29
Registrant information
Name
Maani Beizaei
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
stud6499884464@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of education through three methodes of face to face, multimedia CD and Text messaging on anxiety and vital sign of patients undergoing exercise test
Public title
The effect education volunteer patients exercise stress test.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The age range 20 to 60 years, at least having read and write ability, having a computer and a phone line, does not attend in a similar study; people who have moderate anxiety; exclusion criteria: lack of desire to continue cooperation and withdrew from the study, a history of anti-anxiety drugs usage.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
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 of Shiraz University of Medical Sciences
Street address
Ethics Committee, Seventh floor, Shiraz University of Medical Sciences, next to the Red Crescent Headquarters, Zand Ave., Shiraz
City
Shiraz
Postal code
71348-14336
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
95-01-08-13441

Health conditions studied

1

Description of health condition studied
Coronary heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic Heart Disease

Primary outcomes

1

Description
Anxiety
Timepoint
A week before the intervention and after the intervention
Method of measurement
Beck Anxiety Inventory

Secondary outcomes

1

Description
Vital signs (pulse, blood pressure)
Timepoint
A week before the intervention and after the intervention
Method of measurement
Manometer and monitoring devices

Intervention groups

1

Description
The group control will receive education the method face- to face that inclusive instructions from the before exercise test in communication shave, How to use the drug, How to do exercise test, The cause of the stress test requested by a doctor and routine training.
Category
N/A

2

Description
In the test group with the interactive multimedia CD after the doctor's request for exercise testing, A pre-test will be taken, And then the interactive multimedia CD that is approved by the cardiologist Will be available to patients. Also the researcher control and check to see films by patients, At the time many will be contacted in the event of problems in Movies, In case of difficulty in implementing the movie, will help patients. And the content of the CD is about the purpose and method of performing the exercise test and necessary care before, during and after the test.
Category
N/A

3

Description
The test group with SMS during the course of one week, daily texting in the morning and in the afternoon, including text content on the purpose and how to conduct the exercise test, and the purpose of performing the necessary tests and care before, during and after the test will be sent. Information content In two methods of training Through interactive multimedia and SMS Will be largely considered the same.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic Heart Omidvar Hospital Ewaz
Full name of responsible person
Fozieh Haghighat
Street address
7433195185, Street Beaasat, Evaz
City
Ewaz

2

Recruitment center
Name of recruitment center
Hospital Cardiology Clinic of Imam Reza (AS) Lar
Full name of responsible person
Maani Beizaei
Street address
Lar,new city, Dadman Highway
City
Lar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Science
Full name of responsible person
Dr. Seyd Basir Hashemi
Street address
Vice chancellor for research, seventh floor, Shiraz University of Medical Sciences, next to the Red Crescent headquarters, Zand Ave., 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 Science
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 Science,Shiraz Hazrate Fatemeh Nursing and Midwifery college
Full name of responsible person
Maani Beizaei
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery college, Namazi Square, Shiraz.
City
Shiraz
Postal code
7134-814336
Phone
+98 71 3647 4254
Fax
+98 71 3647 4254
Email
maani.beizaei@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hazrat Fateme College of Nursing and Midwifery
Full name of responsible person
Dr.Kamelia Torabi Zade
Position
PhD, associate professor of nursing education
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery college, Namazi Square, Shiraz.
City
Shiraz
Postal code
1433-671348
Phone
+98 71 3647 4254
Fax
Email
Torabik@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Science,Shiraz Hazrate Fatemeh Nursing and Midwifery college
Full name of responsible person
Maani Beizaei
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery college, Namazi Square, Shiraz.
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
maani.beizaei@yahoo.com
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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