Evaluate the Effect of distraction by virtual reality on pain, anxiety and stress of angiography
Design
Intervention group: In the virtual reality group, 4 days before the angiography and during admission, special glasses are placed on the patient's head, and for 15 minutes they distribute images designed to reduce pain. The severity of anxiety and pain will be measured before and after the intervention.
Settings and conduct
Intervention group: In the virtual reality group, 4 days before the angiography and during admission, special glasses are placed on the head of the patient, and for 15 minutes they distribute images designed to reduce pain. The severity of anxiety and pain will be measured before and after the intervention. this study will be conducted in Imam Reza Hospital in Mashhad
Participants/Inclusion and exclusion criteria
Age 18 to 60 Awareness of time, place and persons at the time of data collection At least the reading and writing skills
Intervention groups
patients undergoing angiography
Main outcome variables
pain, anxiety and stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171219037966N4
Registration date:2019-02-02, 1397/11/13
Registration timing:retrospective
Last update:2019-02-02, 1397/11/13
Update count:0
Registration date
2019-02-02, 1397/11/13
Registrant information
Name
Amirreza Nasirzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
nasirzadeh@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2018-11-03, 1397/08/12
Actual recruitment start date
2018-08-14, 1397/05/23
Actual recruitment end date
2018-12-13, 1397/09/22
Trial completion date
2019-01-25, 1397/11/05
Scientific title
Effect of distraction by virtual reality on pain, anxiety and stress of angiography
Public title
Effect virtual reality on angiography
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60
Awareness of time, place and persons at the time of data collection
At least the reading and writing skills
Exclusion criteria:
The patient's unwillingness to continue the research
Continuous use of analgesics 24 hours before intervention
Continuous use of anti-anxiety 24 hours before intervention
Sight or hearing problems
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the method of permutation blocks (4 blocks, 20) is used.
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 Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2018-01-31, 1396/11/11
Ethics committee reference number
IR.GMU.REC.1396.174
Health conditions studied
1
Description of health condition studied
Cardiac catheterization
ICD-10 code
I20
ICD-10 code description
Angina pectoris
Primary outcomes
1
Description
Anxiety level
Timepoint
4 days prior to angiography, time of the addmission
Method of measurement
Spielberger state-trait anxiety inventory
2
Description
Stress
Timepoint
4 days prior to angiography, time of the addmission
Method of measurement
DASS-21
3
Description
pain
Timepoint
During Angiography
Method of measurement
NSR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the virtual reality group, 4 days before the angiography and during admission, special glasses are placed on the head of the patient, and for 15 minutes they distribute the images designed to reduce the pain. In supine position, then a few deep abdominal breaths and The diaphragm is closed and comfortable in the best condition in which it relaxes. By providing a quiet, quiet environment and by minimizing environmental stimuli (such as low light, travel restrictions), the client will watch virtual reality imagery. The severity of anxiety, stress, and pain will be measured before and after the intervention.
Category
Treatment - Other
2
Description
Control group: 4 days before angiography and during admission without intervention, the intensity of anxiety, pain and pain will be measured during stroke. In this group, there will be no intervention to watch virtual reality movies.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Amirreza Nasirzadeh
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9691945182
Phone
+98 51 3802 2000
Email
nasirzadeharnz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Sajjadi
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
Sajjadi84a@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Amirreza Nasirzadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
nasirzadeharnz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
kokab basiri moghaddam
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 515722302
Email
k.basiri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
amirreza nasirzadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
nasirzadeharnz@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