The Effect of Virtual Reality Distraction on Patient's Anxiety Before Coronary Angiography
Design
Two arm parallel group (intervention and control) randomized clinical trial, no blinded, daily simple random sampling method, sample size is 80 participants.
Settings and conduct
To create virtual reality in the intervention group, we will use a virtual reality headset, a mobile phone and headphones to play the sound. A video via a mobile phone will be played that can change the viewing angle of 360 degrees while changing the patient's head position. Its contents include relaxing landscapes such as nature, beach, sea, etc. The video will be played by mobile phone, before transporting the patient to the Cardiac Angiography Suite of Heshmat Educational Medical Center.
Participants/Inclusion and exclusion criteria
All patients aged 40 to 60 years old are candidates for angiography; No history of angiography; Lack of motion sickness; No severe audio and visual disability; Lack of psychiatric disease; Not wanting to continue the experimental sample; No symptoms of anxiety
Intervention groups
Intervention involves the implementation of virtual reality on mobile phone for intervention group. In the control group, virtual reality will not be implemented. The equivalent time playing virtual reality for the intervention group will be present in the control group. The researcher will be next to the participant and no action will be taken.
The Effect of Virtual Reality Distraction on Patient's Anxiety Before Coronary Angiography
Public title
Effect of Virtual Reality Distraction on Patient's Anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients aged 40 to 60 years old candidated for angiography
Exclusion criteria:
History of Angiography
Motion Sickness
Intense Hearing and Visual Disability
Psychiatric Diseases
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be performed with daily simple random sampling method. First, on a piece of paper, the name of the "intervention group", and on an another one, the name of the "control group" will be written, and placed in a bowl. Then one of the colleagues who do not have a role in sampling will randomly draw a paper. Whatever the result, the first day of sampling will be assigned to that group; then the next day, the sampling will be assigned to the other group. In other words, in one day, samples of the intervention group, and the next day the control group will be collected. Each groups, which reach earlier to 40, sampling for the other group will continue in the same way at one-day intervals to complete the sampling process for that group.
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
Guilan University of Medical Sciences
Street address
Gillan - Rasht - Namjoo Street - opposite Azodi Stadium - Gilan University of Medical Sciences
City
Rasht
Province
Guilan
Postal code
65385-41446
Approval date
2018-12-31, 1397/10/10
Ethics committee reference number
IR.GUMS.REC.1397.369
Health conditions studied
1
Description of health condition studied
Anxiety in candidates for coronary angiography
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety Scale in Short Version of the Spielberger's Anxiety Measurement Scale
Timepoint
Measuring anxiety score before and after intervention
Method of measurement
Short Version of the Spielberger's Anxiety Measurement Scale
2
Description
Systolic and diastolic blood pressure
Timepoint
Measuring systolic and diastolic blood pressure before and after intervention
Method of measurement
Aneroid sphygmomanometer
3
Description
Heart rate in one minute
Timepoint
Counting heart rate in one minute before and after intervention
Method of measurement
A stopwatch of a digital watch
4
Description
Respiratory rate in one minute
Timepoint
Counting respiratory rate in one minute
Method of measurement
A stopwatch of a digital watch
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention involves the implementation of virtual reality on mobile phone for intervention group. In the control group, virtual reality will not be implemented. To create virtual reality in the intervention group, we will use a virtual reality headset, a mobile phone and headphones to play the sound. A video via a mobile phone will be played that can change the viewing angle of 360 degrees while changing the patient's head position. Its contents include relaxing landscapes such as nature, beach, sea, etc. The video will be played by mobile phone, before transporting the patient to the Cardiac Angiography Suite. Sounds include soft music, birds singing and the sound of the waterfall. The duration of this video will be 5 minutes.
Category
Prevention
2
Description
Control group: In the control group, virtual reality will not be implemented. The equivalent time playing virtual reality for the intervention group will be present in the control group. The researcher will be next to the participant and no action will be taken.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Heart Dr Heshmat
Full name of responsible person
Mohammad Reza Yeganeh
Street address
15 Azar St, next to Management and PlaningOrganization
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 9064
Fax
+98 13 3366 8718
Email
heshmat@gums.ac.ir
Web page address
http://www.gums.ac.ir/heshmat
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Opposite17th Shahrivar Hospital, Shahid Siadati St.,Namjou St.
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5821
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
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
Mohammad Reza Yeganeh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery Faculty, Guilan University of Medical Sciences, Daneshjoo St., Shahid Beheshti A
City
Rasht
Province
Guilan
Postal code
416351873
Phone
+98 13 1555 5056
Fax
+98 13 1555 0097
Email
yeganeh@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Yeganeh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery Faculty, Guilan University of Medical Sciences, Daneshjoo St., Shahid Beheshti Ave., Rasht
City
Rasht
Province
Guilan
Postal code
41469-39814
Phone
+98 13 1555 5056
Fax
Email
yeganeh@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Yeganeh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing & Midwifery Faculty, Guilan University of Medical Sciences, Daneshjoo St., Shahid Beheshti Ave., Rasht
City
Rasht
Province
Guilan
Postal code
41469-39814
Phone
+98 13 1555 5056
Fax
Email
yeganeh@gums.ac.ir
Web page address
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The table of final results of the variables in data form and after statistical analysis is sharable without the individual information of each sample.
When the data will become available and for how long
Reachable in 2019
To whom data/document is available
Researchers and students in academic and scientific institutions, people working in the industry
Under which criteria data/document could be used
A variety of statistical analyzes will be allowed on data.
From where data/document is obtainable
Guilan University of medical Sciences, Vice chancellor for research
Corresponding author: Mohammad Reza Yeganeh
Address: Faculty of Nursing & Midwifery, Daneshjou St., Martyr Beheshti Boulevard, Rasht
+981333555058
info@gums.ac.ir
What processes are involved for a request to access data/document
After submitting the application, the application is examined at the research council and the individual can access the data for a maximum of two months.