Investigating the effect of using virtual reality videos during orthodontic treatments on the anxiety of adolescents under treatment in Birjand University Orthodontic Clinic.
the effect of using virtual reality videos during orthodontic treatments on the anxiety of adolescents
Design
The present study was a randomized clinical trial of 66 patients aged 10 to 15 year-old referred to the orthodontics department of the dental clinic of Birjand University of Medical Sciences. Patients were randomly assigned to two groups. By placing a virtual reality headset on the eye during the dental procedure, patients of the intervention group were watching an amusing video-audio VR clip by headset while the control group observed the dentist, the clinic room, and the dental practice around them during the ortodentic treatment. Before and after dental procedures, the anxiety levels of all participants in both groups were assessed by Beck Anxiety Assessment Questionnaire (BAI - Beck Anxiety Inventory).
Settings and conduct
Orthodontics department of the dental clinic of Birjand University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: 10-15 years old, ability to complete the questionnaire.
Exclusion criteria: visual or auditory impairment, insufficient literacy to complete the questionnaire.
Intervention groups
Intervention group: using virtual reality headset.
Control group: routine care.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140611018063N8
Registration date:2020-10-08, 1399/07/17
Registration timing:retrospective
Last update:2020-10-08, 1399/07/17
Update count:0
Registration date
2020-10-08, 1399/07/17
Registrant information
Name
Ali Rajabpour Sanati
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1067
Email address
ali.poursanati@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using virtual reality videos during orthodontic treatments on the anxiety of adolescents under treatment in Birjand University Orthodontic Clinic.
Public title
Investigating the effect of using virtual reality videos during orthodontic treatments on the anxiety of adolescents
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
10-15 years old
ability to complete the questionnaire
Exclusion criteria:
visual or auditory impairment
insufficient literacy to complete the questionnaire
Age
From 10 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
All the patients will be distributed randomly into two groups of A and B, by randomly choosing one card marked with A or B. Patients in the A group will be considered as the Case group and the patients in the B group will be considered as the Control 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
Research Council of Birjand University of Medical Sciences
Street address
Ghavari ave. Birjand medical university
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2018-11-26, 1397/09/05
Ethics committee reference number
IR.BUMS.REC.1397.307
Health conditions studied
1
Description of health condition studied
Anxiety of adolescents
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety in adolescents following orthodontic procedures
Intervention group: In this group, by placing the virtual reality headset on the eyes of the patients during the dental procedures, they will simultaneously watch a fun multimedia clip of virtual reality.
Category
Treatment - Other
2
Description
Control group: In this group, throughout the orthodontic treatment, patients will see the dentist, the clinic room and especially the dental procedures.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Orthodontics, Dental Clinic, Birjand University of Medical Sciences
Full name of responsible person
Majid Zare_Bidaki
Street address
Ghafari ave -Birjand
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3222 2300
Fax
+98 56 3222 7686
Email
m.zare@live.co.uk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Majid Zare_Bidaki
Street address
Ghafari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3222 2300
Fax
+98 56 3222 7686
Email
m.zare@live.co.uk
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
Majid Zare_Bidaki
Position
PHD
Latest degree
Medical doctor
Other areas of specialty/work
Microbiology
Street address
Ghafari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3222 2300
Fax
+98 56 3222 7686
Email
m.zare@live.co.uk
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
S. Sadegh Hosseini Sede
Position
M.D
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Moallem Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3222 2300
Fax
+98 56 3222 7686
Email
m.zare@live.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
S. Sadegh Hosseini Sede
Position
M.D
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ghafari ave, Birjand
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3222 2300
Fax
+98 56 3222 7686
Email
m.zare@live.co.uk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available