Comparison of the effect of virtual reality with two approaches of distraction and educational film on anxiety and hemodynamic parameters in patients undergoing cardiac angiography
Comparison of the effect of virtual reality with two approaches of distraction and educational film on anxiety and hemodynamic parameters in patients undergoing cardiac angiography
Design
Clinical trial with control group, with parallel group; Double blind, randomized
Settings and conduct
This study is being performed at Razi Hospital in Birjand, South Khorasan Province. 90 patients are randomly divided into three groups of candidates for angiographic surgery of the control group and the group receiving the video of deviance and educational video. Then, the level of anxiety and hemodynamics of patients in the three groups before and after angiography will be examined by the nurse without knowing the patient's group.
Participants/Inclusion and exclusion criteria
Criteria for entering the study will include a candidate for angiography, a willingness to participate in the study, an age range of 35 to 70 years, and the necessary visual and auditory health to participate in the study.
The criteria for leaving the study include incomplete completion of the questionnaire by patients and patients' refusal to continue participating in the study, phobia of natural landscapes and wildlife, use of anti-anxiety drugs, neurological disorders, and patients with variable and critical hemodynamic conditions.
Intervention groups
Patients will be randomly assigned to be divided into one of three groups: intervention one (educational video), intervention two (including mental deviation film), or control group.
Main outcome variables
Anxiety
Patients' hemodynamics
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190618043934N6
Registration date:2020-07-20, 1399/04/30
Registration timing:retrospective
Last update:2020-07-20, 1399/04/30
Update count:0
Registration date
2020-07-20, 1399/04/30
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of virtual reality with two approaches of distraction and educational film on anxiety and hemodynamic parameters in patients undergoing cardiac angiography
Public title
The Impact of Virtual Reality on Anxiety and Hemodynamic Indicators Patients Candidate for Cardiac Angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for angiography
Having a conscious consent to participate in the study
Age range 35 to 70 years
Having visual and auditory health
Exclusion criteria:
Incomplete completion of the questionnaire by patients
The patient refuses to continue studying
Fear of natural landscapes and wildlife
Taking anti-anxiety medications
Suffering from neurological diseases
Patients with variable and critical hemodynamic conditions
Age
From 35 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The placement of individuals in each group will be randomly simple and blocked. In one of the three groups, intervention A (educational video), intervention B (including deviant film) or control group C will be placed. First, various triple blocks are created on different cards (ABC, CAB, CBA, BCA, BAC and ACB). One of these blocks is randomly selected and patients will be divided into one of three groups A, B or C. Then randomization is performed for other patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Data Analyzer: Without knowing the type of video shown to patients
Outcome Assessor: The ward nurse asks patients questions without knowing the type of medication received and records them in the relevant checklist.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari BLV
City
Birjand
Province
South Khorasan
Postal code
9717811674
Approval date
2020-02-10, 1398/11/21
Ethics committee reference number
IR.BUMS.REC.1398.360
Health conditions studied
1
Description of health condition studied
cardiovascular disease
ICD-10 code
A52.0
ICD-10 code description
Cardiovascular and cerebrovascular syphilis
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after angiography
Method of measurement
Spielberger Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 30 patients are candidates for angiography who are not shown a film.
Category
Rehabilitation
2
Description
Thirty patients are candidates for angiography for whom a virtual film with entertaining content and nature documentaries is shown to them through three-dimensional glasses, which is similar to the length of the patient film (5 minutes in Persian) in the intervention group.
Category
Rehabilitation
3
Description
30 patients are candidates for angiography surgery. The 3D educational video about the process of angiography surgery, which is the source of this video, is a valid medical books, authoritative articles and cardiologists. This video will be for 5 minutes in Persian. Regarding the environment for performing angiography and the equipment that will be encountered at the beginning of the patient's arrival and after work.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital in Birjand
Full name of responsible person
Mohammad Ali Sadeghi
Street address
Ghaffari Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Tooba Kazemi
Street address
Ghaffari Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3238 1200
Email
oabstudent@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
Moallem Blvd
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Davoud Oudi
Position
Member of the Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Moallem Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
Moallem Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no need to publish individual patient information
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