Determining the Effect of Mobile Based Education on Anxiety Reduction and Changes in Physiological Indices in Candidate Patients for Coronary Angiography
Design
It's clinical trial. The research sample consisted of 94 patients who were candidates for coronary artery angiography who were selected from the research community based on entry criteria, then random allocation, and non-probabilistic, easy-to-target and goal-based method, and were divided into two groups of 47 students with software and control software Routine training will be divided.
Settings and conduct
Initially refer to the angiographic section and select patients based on the criteria of entry and then obtain informed consent. Patients will be divided into two treatment groups with software downloads and control group with routine training.
Random assignment is done to prevent contact between patients in two groups and the samples are placed in the test and control group one day. Then, the physiological and spill-burger indices are obtained in the following way.
1- when the patient is nominated by a doctor.
2- half an hour after entering the department and performing routine pre-angiography operations in bed rest.
3-immediately befor angiography.
Participants/Inclusion and exclusion criteria
Would like to participate in the research project
Have a mobile phone with application software.
Have the ability to read, or have a family member who is close to the patient.
Not having a history of chronic mental illness (such as depression and chronic anxiety, psychosis, etc.) before performing angiography.
The patient is not angiographed as an emergency candidate.
Do not complain of chest pain.
Intervention groups
Patients who receive training through mobile software
Main outcome variables
Improvement of patient's educational level and consequently reduce patient anxiety and maintain physiological parameters within normal range
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190119042407N1
Registration date:2019-03-05, 1397/12/14
Registration timing:retrospective
Last update:2019-03-05, 1397/12/14
Update count:0
Registration date
2019-03-05, 1397/12/14
Registrant information
Name
ehsan zafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4263 3716
Email address
eh.zafari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-26, 1397/11/06
Expected recruitment end date
2019-02-25, 1397/12/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mobile-based education on anxiety and physiological indices of candidates for coronary artery angiography
Public title
The effect of mobile-based education on anxiety and physiological indices of candidates for coronary artery angiography
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patients undergoing coronary artery angiography
For the first time candidate for angiography
Exclusion criteria:
Patients who do not have access to smart phones
Patients who do not read and write
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning the intervention was randomized and random blocked blocks with block size 4
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 Ahwaz Jundishapor University of Medical Sciences
Street address
Academic City, Adjacent to Central Office of Jundishapur University of Medical Sciences and Health Services, Ahwaz, Deputy of Research and Technology Development.َ
City
Ahwaz
Province
Khouzestan
Postal code
15794 - 61357
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.AJUMS.REC.1397.748
Health conditions studied
1
Description of health condition studied
A Study of Mobile Based Learning Strategy on Reducing Anxiety in Candidate Patients for Coronary Angiography
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The open and hidden anxiety variables are made up of 40 questions by the Spielberger questionnaire. This questionnaire is used to measure the amount of anxiety. The first 20 questions were the anxiety state (apparent anxiety) and 20 questions of the anxiety tract (hidden anxiety). puts. In answering subjects to anxiety, there are a number of options for each statement, which they should select the option that best expresses their emotion. These options are: 1. Altogether 2. Altogether 3. Medium 4. Altogether. Options to respond to the anxiety tract scale include: 1. Almost never 2. Sometimes 3. Often 4. Almost always. In order to obtain an individual's anxiety score in each of the two scales, the total score of all twenty words of each scale is computed with respect to the fact that some of the phrases are translated verbatim and some of the terms are scored in reverse order. Therefore, the scores of each of the two state scales and the anxiety trap can range from 20 to 80. Scoring weights are inverse for non-anxiety expressions. The terms that are scored in reverse order when scoring, that is, in these questions the answer of a score of 3, the response of the two scores 2, and the response of a score of 1, are: the scale of the anxiety state: 20, 19, 16, 15, 11, 10, 8, 5, 2, 1 Anxiety Tract Scale: 39, 36, 34, 33, 30, 27, 26, 23, 21 The rest of the questions are scored directly, so that the answers to these questions A score of 1, a double response, and a three-point response score of 3. According to the scale of the case, scores 20-30 represent no apparent anxiety, scores 42-31 indicate a clear, mild anxiety, scores 53-43 represent moderate anxiety and scores of 54 and more indicate severe anxiety. According to the vein scale, scores of 34-20 did not indicate or the lowest amount of hidden anxiety, scores of 45-35 representing mild anxiety, scores 56-46 representing moderate anxiety and scores of 57 and more indicate severe anxiety, this factor is mild, moderate Or the severity of the level of apparent and hidden anxiety is measured.
Timepoint
The first turn is when the patient is angiographed by the candidate. A second shift takes place half an hour after entering the department and performing routine routine pre-angiography at rest in the bed. The third appointment is immediately investigated as soon as the patient is called to perform angiography. Further, the data will be taken through the statistical analysis methods described in the next section and will be carefully evaluated.
Method of measurement
Spielberger Questionnaire, Physiological Indicator Questionnaire, Rossmax Manometer Device Made in Taiwan, CE Certificate
The first turn is when the patient is angiographed by the candidate. A second shift takes place half an hour after entering the department and performing routine routine pre-angiography at rest in the bed. The third appointment is immediately investigated as soon as the patient is called to perform angiography. Further, the data will be taken through the statistical analysis methods described in the next section and will be carefully evaluated.
Method of measurement
Spielberger Questionnaire, Physiological Indicator Questionnaire, Rossmax Manometer Device Made in Taiwan, CE Certificate
Intervention groups
1
Description
Intervention group: In the intervention group, educational content is presented using mobile software. To this end, the educational materials including familiarity of the patient with the process of angiography and its adaptation, its complications, familiarity with the angiography, anxiety control methods based on psychological references in a face-to-face meeting were developed as a program and Certification supervisors are displayed to the patient as software on a mobile phone and expressed by the researcher on how to use it.
Category
Other
2
Description
Control group: The patient will receive the educational content routinely in the Angiography ward
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Ehsan Zafari
Street address
Farvardin Ave. Golestan Area
City
Ahwaz
Province
Khouzestan
Postal code
61357-3318
Phone
+98 61 3374 3061
Email
golestanhospital@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology University
Street address
Academic town Adjacent to Central Office of Jundishapur University of Medical Sciences and Health Services, Ahwaz
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ehsan Zafari
Position
Medical Emergency Technician
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 325, Mostafa Khomeini Ave
City
Andimeshk
Province
Khouzestan
Postal code
6481749786
Phone
+98 61 4263 3716
Fax
Email
eh.zafari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dariush Rokhafroz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Faculty of Nursing and Midwifery, Jundishapur University of Ahvaz
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61337338070
Email
darushrokhafroz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dariush Rokhafroz
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Faculty of Nursing and Midwifery, Jundishapur University of Ahvaz
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61337338070
Email
darushrokhafroz@gmail.com
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