The present study will be aimed to investigate the effects of VR technology on anxiety in patients undergoing endoscopy.
Design
In this research, the samples were selected by a goal-based method of 60 people and then assigned randomly to two groups of intervention (30 people) and control (30 people).
Settings and conduct
The inpatient and outpatient endoscopy candidates in Modarres hospital in Kashmar city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having an order for the upper gastrointestinal endoscopy
Age between 30 and 60 years
No history of previous endoscopy
Not having an emergency endoscopy
Do not take drowsy and sedative medicines
Not having severe pain due to the nature of the disease (such as cancer)
No drug addiction or strong analgesic
Exclusion criteria: Lack of hearing or visual impairment
Create intense anxiety at each stage of the study
Intervention groups
After obtaining written informed consent for participation in this research, demographic information questionnaire and Spielberger's revealing anxiety scale questionnaire containing 20 quadratic questions were completed in two groups before intervention, then the intervention group faced with virtual reality as follows: That is, while glasses are placed on the person's eyes that you know from the vast viewpoint, and provides him with a good view of the eye. The tool used for virtual reality technique is a virtual reality headset device that displays a simple film about endoscopy and nature film with high quality waterfall images and sound in a 15-minute interval for the pre-endoscopic test group. Then the anxiety is re-evaluated .in The end, data will analyzed by statistic tests using spss.
Main outcome variables
To reduce fear and anxiety related to endoscopy and decrease significant statistics in relation to the refusal to do so.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180529039903N1
Registration date:2018-07-16, 1397/04/25
Registration timing:registered_while_recruiting
Last update:2018-07-16, 1397/04/25
Update count:0
Registration date
2018-07-16, 1397/04/25
Registrant information
Name
Tahmine Ghasimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5523 6303
Email address
ghasimi.t@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-21, 1397/03/31
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: The Effect Of Virtual Reality On Anxiety in Patients Undergoing Upper Gastrointestinal Endoscopy
Public title
: The Effect Of Virtual Reality On Anxiety in Patients Undergoing Upper Gastrointestinal Endoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having an order for the upper gastrointestinal endoscopy
Age between 30 and 60 years
No history of previous endoscopy
Not having an emergency endoscopy
Do not take drowsy and sedative medicines
Mental consciousness and non-mental disorders (based on medical records)
Not having severe pain due to the nature of the disease (such as cancer)
No drug addiction or strong analgesic
Failure to record a new crisis, such as the death of a first-degree relative in the past six months
Lack of hearing or visual impairment
Exclusion criteria:
Unwillingness to continue to participate in the study for any reason
Create intense anxiety at each stage of the study
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the samples were selected by objective method and then assigned Simple randomization to intervention and control groups.
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
Ethnical Committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2017-09-27, 1396/07/05
Ethics committee reference number
IR.GMU.REC.1396.67
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Organic anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
before and after intervention
Method of measurement
STAI
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, the tool used for virtual reality technique is a virtual reality headset device, a simple film about endoscopy and nature film with high quality waterfall images and sounds in a 15 minute interval before the endoscope.
Category
Treatment - Other
2
Description
Control group: Receive routine care without any special intervention
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid modarres hospital
Full name of responsible person
Tahmine Ghasimi
Street address
17 Shahrivar Ave
City
Kashmar
Province
Razavi Khorasan
Postal code
9671616669
Phone
+98 51 5522 7402
Email
ghasimi.t@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpur
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
info@gmu.ac.ir
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
Habib Shareinia
Position
Instructor at School of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
shareinia.msn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpur
Position
head of the University of Nursing and Midwifery Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5027
Email
amohammadpur@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Tahmine Ghasimi
Position
student at master nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Edalat Ave
City
Kashmar
Province
Razavi Khorasan
Postal code
9671936686
Phone
+98 51 5523 6303
Email
ghasimi.t@gmu.ac.ir
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