Determining effect of animation-based education on anxiety and hemodynamic status of coronary angiography candidate patient
Design
Clinical trial with control group, parallel groups, randomized by time block method, phase 3 on 30 patients in each group. For randomization, radomization site and envelope in package were used.
Settings and conduct
The research population is all patients who are candidates for coronary angiography admitted to the post-angiography department of Imam Reza Teaching Hospital in Mashhad. An animation is prepared for the animation group and an educational video with similar educational content is prepared for the control group. On the morning of the angiography, about one to three hours before the angiography, the patients of each group are asked to watch the relevant file. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
Coronary angiography candidate patients without previous history of angiography, who are willing to participate in the research.
Intervention groups
In the animation group, a 3-7 minute animation is prepared with the two-dimensional method. This animation describes the indications of angiography, events during the procedure, risks and benefits, and an educational video with similar educational content is prepared for the control group. On the morning of the angiography, about 1 to 3 hours before the angiography, the patients of each group are asked to watch the related file.
Main outcome variables
anxiety;
Hemodynamic parameters: including systolic and diastolic blood pressure, mean arterial pressure and heart rate.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240719062475N1
Registration date:2024-08-05, 1403/05/15
Registration timing:prospective
Last update:2024-08-05, 1403/05/15
Update count:0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
Sajede Yaghmaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5523 6012
Email address
sajede.ya@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of animation-based education on anxiety and hemodynamic status of coronary angiography candidate patients
Public title
The effect of animation on anxiety and hemodynamic status of coronary angiography candidate patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age should be 65-40
Consent to participate in the research
Be alert
Have the ability to speak and communicate.
Do not have a history of previous angiography
The order for the patient's angiography is not an emergency
Do not have a work history as a medical staff
Do not have a visual defect that cannot be corrected with correction facilities
Don't have a hearing impairment that cannot be corrected with correction facilities
Be fluent in Persian language.
Exclusion criteria:
Have a confirmed history of mental illness.
Have a history of taking anti-anxiety medication in the last 6 months.
Have a history of severe stressful situations in the last 6 months.
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The research units are selected as available, based on the entry criteria, and then randomly assigned to one of the intervention or control groups.
In order to prevent the dissemination of information and the communication of the groups with each other and interference in the nurses' care method, allocation to two groups will be done randomly based on the day of referral for angiography. In this way, with the random time block method, a random sequence is designed for 30 working days for two animation and control groups by the Randomization site. The obtained sequence will be written on small cards and kept in the envelope in the closed order. On each sampling day, in the opened envelope, the card placed in the same order is taken out to determine which group the patients should be placed in on that day. The reason for using the envelope is to keep the random sequence confidential.
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 Faculty of Nursing and Midwifery - Mashhad University of Medical Sciences
Street address
Shahid Dr. Kharazmi Educational Complex, East Gate, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Approval date
2024-06-11, 1403/03/22
Ethics committee reference number
IR.MUMS.NURSE.REC.1403.025
Health conditions studied
1
Description of health condition studied
Ischaemic heart diseases
ICD-10 code
I24.8
ICD-10 code description
Other forms of acute ischemic heart disease
Primary outcomes
1
Description
The score that a person gets from the anxiety scale
Timepoint
The anxiety of the research units participating in the study will be measured as a pre-test at the beginning of the study (before the intervention) and at the same time in the control group. It will also be measured and recorded as a post-test in each group before going to angiography and about an hour after returning under the same conditions.
Method of measurement
In this research, the Spielberger State-Trait Anxiety Inventory (STAI) will be used to measure anxiety
2
Description
Hemodynamic parameters include systolic and diastolic blood pressure, mean arterial blood pressure, heart rate
Timepoint
The hemodynamic parameters of the research units participating in the study will be measured as a pre-test at the beginning of the study (before the intervention) and at the same time in the control group. It will also be measured and recorded as a post-test in each group before going to angiography and about an hour after returning under the same conditions.
Method of measurement
Hemodynamic parameters including systolic and diastolic blood pressure and mean arterial blood pressure are measured by the Saadat monitoring device, and the new pulse oximeter will be used by the researcher to measure the heart rate and recorded in the relevant table by the researcher.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: For the animation group, the animation is prepared with the two-dimensional method for 3-7 minutes. This video describes the indications of the procedure, events during the procedure, risks and benefits.. This video is designed to be viewed on smartphones, tablets, as well as computers. The videos for each group will be played by the researcher on the researcher's mobile phone. And if the patient needs, the video will be repeated one more time. The educational content of the animation and educational video will be sent to 7 experts before production and their corrective comments will be applied. After the production of the initial version of the animation and educational film, this version is given to the experts so that the final version can be prepared with their correction comments, and this version is used as a pilot for a group of patients, and its shortcomings will be fixed. And the animation of the content will be done by the animator team using software such as Adobe Photoshop, Adobe Illustrator, Adobe After Effects, Adobe Premiere, etc., and then the sound will be added. The animation process will be done as follows: 1. - At first, the complete motion graphics scenario is written. 2- At this stage, the mentioned text will be recorded by a speaker. 3- Based on the time and content determined, the sequence and plans are adjusted and stratified by the team, as well as the storyboard work. It will be ready. 4- Then the plans will be designed by Illustrator and Photoshop software. 5- In Illustrator and Photoshop software, all the characters and shapes that need to be animated will be layered and named. 6- Designed plans It will be entered into the After Effects software layer by layer and will be animated based on the time and the recorded sound. 7- The sequences will be outputted separately and entered into the Premiere software. can be
Category
Other
2
Description
Control group: For the control group, an educational video with similar educational content will be prepared and will be provided to the relevant group. that photos and videos and verbal explanations will be used in this film.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Post-Angiography Department
Full name of responsible person
Seyed Reza Mazloum
Street address
Imam Reza Educational Research and Treatment Center, Imam Reza Hospital Square, Ebn Sina Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
b.imamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tasfaghodi
Street address
Research and Technology Vice-Chancellor of Mashhad University of Medical Sciences, second floor, Qureshi Building,, front of University 16 Ave, University Ave
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3815 4138
Email
Tafaghodim@MUMS.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Reza Mazloum
Position
teacher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Kharazmi Educational Complex, East Gate, University Campus, Azadi Square
City
mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3859 8019
Email
mazlomr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sajede Yaghmaee
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Kharazmi Educational Complex, East Gate, University Campus, Azadi Square
City
mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3859 8019
Email
yaghmaeis4001@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sajede Yaghmaee
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Kharazmi Educational Complex, East Gate, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177949025
Phone
+98 51 3859 8019
Email
Yaghmaeis4001@mums.ac.ir
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
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
Title and more details about the data/document
All data obtained from this research will be shared after completion.
When the data will become available and for how long
Access to the data will be possible three months after the results are published.
To whom data/document is available
These data will be used for researchers working in academic and scientific institutions, as well as for patients who are candidates for coronary angiography.
Under which criteria data/document could be used
The data obtained in this research can be used in other scientific studies
From where data/document is obtainable
Copying (in any way) either from the full text or from their extraction, is possible only with the coordination of the supervisor and the registered author and based on the instructions provided by the Central Library of Mashhad University of Medical Sciences. Details can be accessed through the library of the respective faculty. The use of the thesis in articles with any scientific writing depends on mentioning the source and complying with the publishing rules of Mashhad University of Medical Sciences.
Seyed Reza Mazlom: mazlomr@mums.ac.ir
Sajideh Yaghmaei: Yaghmaeis4001@mums.ac.ir
What processes are involved for a request to access data/document
The author should send an email to the responsible author and register his request. After checking the correctness of the information of the mentioned person, the required content will be provided to him by mentioning the source.