Protocol summary

Summary
Cardiovascular diseases are the main causes of death in United States and around the world and it is the number one killer in Iran. Cardiovascular diseases in Iran are the leading cause of death responsible for 39.3% of total deaths. Recently cardiac catheterization common procedure and diagnostic methods that used in all over the world and almost 6000 person from 1 million of western countries use this method in a one year. In most cases invasive diagnostic method have a stress and anxiety for patient. Patient that undergoing coronary angiography may be anxious that what happen in angiography room and anxiety increase in the waiting period immediately prior to the procedure. This anxiety decrease level of comfort and satisfaction of patients. Patient’s orientation with environment increase level of comfort and satisfaction. Inadequate education and lack of sufficient research whereby the design of this study to increase level of comfort and satisfaction of patients that undergoing coronary angiography.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017030332303N2
Registration date: 2017-04-11, 1396/01/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-11, 1396/01/22
Registrant information
Name
Morteza Shamsizadeh
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0535
Email address
shamsizadeh@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of video based education on comfort and satisfaction in patients undergoing coronary angiography
Public title
The effects of video based education on comfort and satisfaction in patients undergoing coronary angiography in Hamadan Farshchian Hospital
Purpose
Other
Inclusion/Exclusion criteria
The inclusion criteria: age between 30 - 75; do not have a history of previous angiography; scheduled for elective, non- emergency; do not have a psychosis; able to understand and speak Persian language; do not have a mental retardation and unheard. The exclusion criteria: patients admitted for an emergency cardiac catheterization; history of previous cardiac catheterization; patients with cognitive impairment; patients with a history of taking psychotropic agents; those having major hearing or visual difficulties because hearing and visual capabilities are needed to comprehend the material presented in the educational intervention; those having a life-threatening or an associated major illness such as renal failure or cancer because these serious illnesses may differently affect patients’ anxiety level and their way of dealing with stressful events, and those have deteriorated health conditions prior to or post- cardiac catheterization and need to be admitted for intensive care unit.
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
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
Hamedan University of Medical Sciences
Street address
Fahmideh Street, Hamedan University of Medical Sciences, Hamedan
City
Hamedan
Postal code
651783-8698
Approval date
2017-02-19, 1395/12/01
Ethics committee reference number
IR.UMSHA.REC.1395.544

Health conditions studied

1

Description of health condition studied
Cardiovascular disease
ICD-10 code
I25.1
ICD-10 code description
I25.1 Atherosclerotic heart disease Coronary (artery): • atheroma • atherosclerosis • disease • sclerosis

Primary outcomes

1

Description
Comfort
Timepoint
Before and after education
Method of measurement
Visual Analog Scale

2

Description
Satisfaction
Timepoint
After education
Method of measurement
Astley questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
All patients receive the usual care including a written pamphlet and brief information regarding the cardiac catheterization procedure, such as time for fasting, skin preparation, wound care, routine hemodynamic observations, and pain management.
Category
Other

2

Description
In addition to usual care, patients in the experimental group receive an educational video which take place in the same room. The educational session provide by one of the investigators with a 40-minute educational videotape. This video have 4 part that each part have a 10 minutes. First part about physical environment of angiography room and equipment of this room. Another parts about preoperative, intraoperative and post-operative care for patients. Participants able to ask for further information after viewing the video. Content validity of the videotape establish by an expert cardiologist who frequently performed cardiac catheterization.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Cardiovascular subspecialty Hospital
Full name of responsible person
Ehsan Movaheditabar
Street address
Fahmideh Street, Hospital Heart Farshchian, Hamedan
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor of Hamedan University of Medical Sciences
Full name of responsible person
Ehsan Movaheditabar
Street address
Fahmideh Street, Hamedan University of Medical Sciences, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Khodayar Oshvandi
Position
Ph.D of Nursing
Other areas of specialty/work
Street address
Fahmideh Street, Hamedan University of Medical Sciences, Hamedan
City
Hamedan
Postal code
651783-8698
Phone
+98 81 3838 1480
Fax
+98 81 3838 0447
Email
oshvandi2005@yahoo.com
Web page address
www.umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Khodayar Oshvandi
Position
Ph.D of Nursing
Other areas of specialty/work
Street address
Fahmideh Street, Hamedan University of Medical Sciences, Hamedan
City
Hamedan
Postal code
651783-8698
Phone
+98 81 3838 1480
Fax
+98 81 3838 0447
Email
oshvandi2005@yahoo.com
Web page address
www.umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Khodayar Oshvandi
Position
Fahmideh Street, Hamedan University of Medical Sciences, Hamedan
Other areas of specialty/work
Street address
Ph.D of Nursing
City
Hamedan
Postal code
651783-8698
Phone
+98 81 3838 1480
Fax
+98 81 3838 0447
Email
oshvandi2005@yahoo.com
Web page address
www.umsha.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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