Determining the effect of education with film on anxiety level of patients undergoing coronary angiography in educational therapeutic center of heshmat in Rasht
Design
Randomized clinical trial with control group, community-based, single blind, randomized
Settings and conduct
Samples will be drawn by lottery and will be randomly assigned to the studied groups. After reviewing the eligible patients, they will be satisfied.
A draw box in which 2 are three paper with numbers 1(test) and 2(control) in it is provided to the patient to randomly remove a number. That number represents the group in which it is placed. If the number of samples of each group is completed, that number will be withdrawn from the lottery container. This will continue to the required number of samples for two groups.
The sample size of each group is 64 patients. For the test group, the questionnaire is completed first day before the angiography, Then the educational film is provided to the patient and after all the patient's questions will be answered. However, in the control group the day before the angiography, the questionnaire was completed by the patient and the patient receives only routine hospitalized training. Then, the morning of the angiography, the anxiety questionnaire is again completed by the patients. one of the patients knew the type of training in the other group, and each group was checked in a week to not interact.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient satisfaction, 25-75 years, no history of angiography, the ability to communicate verbally and understand Persian language, Lack of blindness and deafness
Exclusion criteria: Detection of anxiety and depression in medical records, Cancellation of angiography during study
Intervention groups
The test group receives training through film.
Main outcome variables
anxiety control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180303038934N2
Registration date:2018-10-18, 1397/07/26
Registration timing:registered_while_recruiting
Last update:2018-10-18, 1397/07/26
Update count:0
Registration date
2018-10-18, 1397/07/26
Registrant information
Name
Arezoo Monfared
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 5058
Email address
a.monfared@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of education with film on anxiety level of patients undergoing coronary angiography in educational therapeutic center of heshmat
Public title
The effect of education with film on anxiety level of patients undergoing coronary angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction
25-75 years
no history of angiography
The ability to communicate verbally and understand Persian language
Lack of blindness and deafness
Exclusion criteria:
Detection of anxiety and depression in medical records
Patient dissatisfaction
Cancellation of angiography during study
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be drawn by lottery and will be randomly assigned to the studied groups. After reviewing the eligible patients, they will be satisfied.
A draw box in which 2 are three paper with numbers 1(test) and 2(control) in it is provided to the patient to randomly remove a number. That number represents the group in which it is placed. If the number of samples of each group is completed, that number will be withdrawn from the lottery container. This will continue to the required number of samples for two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
All actions, including the completion of questionnaires and the use of educational film, are done by a researcher and the study is single blind, and the patients in 2 groups are not informed of any of the differences in education.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
In Front of the 17 Shahrivar Hospital .,Seiadati Ave., Namjo Ave., Rasht City
City
Rasht
Province
Guilan
Postal code
39841-41469
Approval date
2017-02-11, 1395/11/23
Ethics committee reference number
IR.GUMS.REC:1395.333
Health conditions studied
1
Description of health condition studied
Coronary Angiography
ICD-10 code
I25
ICD-10 code description
Chronic ischemic heart disease
2
Description of health condition studied
anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
Primary outcomes
1
Description
the spielberger's Anxiety Inventory contains 20 questions for State anxiety and 20 questions for Trait anxiety. The final score is in the range of 80-20 and the higher score indicates more anxiety.
Timepoint
The anxiety questionnaire is completed twice. Before training and after training to the patient
Method of measurement
spielberger's Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the test group, the day before the angiography is completed, the questionnaires are completed and then the educational film will be provided to the patient and after the end of the film all the patient's questions will be answered. Then, the morning of the angiography, the anxiety questionnaire is again completed by the patient.
Category
Behavior
2
Description
Control group: In the control group the day before the angiography, the questionnaire was completed by the patient and the patient receives only routine hospitalized training. Then, the morning of the angiography, the anxiety questionnaire is again completed by the patient.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmat Educational and Therapeutic Center of Rasht
Full name of responsible person
Arezoo Monfared
Street address
Rasht, 15 Khordad Ave. Heshmat Educational and Therapeutic Center of Rasht
City
Rasht
Province
Guilan
Postal code
41448
Phone
+98 13 3366 9064
Fax
Email
a.monfared88@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Street address
In Front of 17 Shahrivar Hospital., Siadati Ave., Namjo Ave., Rasht
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Arezoo Monfared
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
خیابان دانشجو، بزرگراه شهید بهشتی، رشت
City
Rasht
Province
Guilan
Postal code
1873- 41635
Phone
+98 13 3355 5056
Email
a.monfared88@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Arezoo Monfared
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Student Ave., Shahid Beheshti Blu., Rasht
City
Rasht
Province
Guilan
Postal code
1873- 41635
Phone
+98 13 3355 5056
Email
a.monfared88@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Arezoo Monfared
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Student Ave., Shahid Beheshti Blu., Rasht
City
Rasht
Province
Guilan
Postal code
1873- 41635
Phone
+98 13 3355 5056
Email
a.monfared88@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Based on the goals in the design, the amount of anxiety is reported before and after the training and some of the individual information listed in the Variables section
When the data will become available and for how long
Starting from the second half of 2019
To whom data/document is available
Researchers, Guilan University of Medical Sciences, samples of study, University and Hospital Researchers
Under which criteria data/document could be used
Data after analysis, is available to others through publication in scientific journals
What processes are involved for a request to access data/document
Usually, information will be available through the publication of the paper. But if the person asks for more and more information, can submit application by email and phone and in person. Then information will be provided according to the size and type of data that will be considered.