Evaluation the effect of virtual reality on physiological indices and anxiety of patients before wisdom tooth surgery
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
Patients Candidate for wisdom tooth surgery in Mashhad Dentistry School. Operation in Mashhad Dentistry School
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patient's willingness to participate in the study with informed consent
The age range of 18-35 years
Having the necessary visual and auditory ability
Have the ability to read and write in Persian
Exclusion criteria:
History of diagnosed mental illness, cardiovascular disease (myocardial infarction, hypertension, cardiac arrhythmia)
History of diagnosed respiratory illnesses and disorders are
Using the drugs that affect heart and mind and breathing
Previous history of previous surgery
Intervention groups
Intervention group: The tool used for virtual reality technique is a virtual reality headset device, a film about nature with high quality waterfall images and sounds in a 10 minute before the surgery.
Control group: Receive routine care similar to intervention group without any special intervention (VR).
.
Main outcome variables
Anxiety. Physiological indices(blood pressure, pulse rate, rate and rhythm of inspiratory)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181023041425N1
Registration date:2020-03-13, 1398/12/23
Registration timing:registered_while_recruiting
Last update:2020-03-13, 1398/12/23
Update count:0
Registration date
2020-03-13, 1398/12/23
Registrant information
Name
Majid Hosseini Abrishami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
hoseiniabrishamim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-09, 1398/12/19
Expected recruitment end date
2020-05-18, 1399/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual reality on physiological indices and anxiety of patients before wisdom tooth surgery
Public title
The effect of virtual reality on anxiety of patients before wisdom tooth surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's willingness to participate in the study with informed consent
The age range of 18-35 years
Having the necessary visual and auditory ability
Have the ability to read and write in Persian
Exclusion criteria:
History of diagnosed mental illness, cardiovascular disease (myocardial infarction, hypertension, cardiac arrhythmias)
History of diagnosed respiratory illnesses and disorders are
Using the drugs that affect heart and mind and breathing
Previous history of previous surgery
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
First patients will be selected purposefully based on inclusion criteria and then are allocated into intervention and control groups by simple randomization (sortition and alternately).
Blinding (investigator's opinion)
Single blinded
Blinding description
1- Associate researcher who measures anxiety and physiological indicies waits for the patients in a specific room and he is blinded about patients groups. In order to prevent bias, each of people are guided to this room and their anxiety and physiological indicies will be measured and written down.
2-The analyser does not khnow about each of groups data (intervention and control groups).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
No. 20, Mahdi. 1 Ave., Valiasr Blvd., Gonabad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
96919119735
Approval date
2019-07-01, 1398/04/10
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1398.020
Health conditions studied
1
Description of health condition studied
wisdom tooth surgery
ICD-10 code
Z98.818
ICD-10 code description
Other dental procedure status
Primary outcomes
1
Description
physiological indices and anxiety before surgery
Timepoint
10 minutes before and after intervention
Method of measurement
Spielberger scale and physiological indices form, Monitoring system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, consent form and demographic information questionnaire will be completed. Then we measure anxiety and physiological indicies. Patients use virtual reality technique (includes a system and headset with high quality) for 10-15 minutes before injection. Then anxiety and physiological indicies are measured again and the surgery is done.
Category
Other
2
Description
Control group: In this group, all the steps explained in the intervention group will be done except using virtual reality system. Patients Wait for surgery without intervention(VR) and anxiety and physiological indicies are measured again exactly like the previous group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dentistry School
Full name of responsible person
Hoseini Abrishami Majid
Street address
No. 20, Mahdi. 1 Ave., Valiasr Blvd., Gonabad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
96919119735
Phone
+98 51 3882 9502
Fax
+98 51 3882 9500
Email
HoseiniAbrishamiM@mums.ac.ir
Web page address
http://dentistry.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hoseini Bagheri (Research Chancellor)
Street address
No. 20, Mahdi. 1 Ave., Valiasr Blvd., Gonabad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
96919119735
Phone
+98 51 3882 9502
Fax
+98 51 3882 9500
Email
BagheriH@mums.ac.ir
Web page address
http://dentistry.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
70
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
Mashhad University of Medical Sciences
Full name of responsible person
Hoseini Abrishami Majid
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 20, Mahdi. 1 Ave., Valiasr Blvd., Gonabad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
96919119735
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
HoseiniAbrishamiM@mums.ac.ir
Web page address
http://dentistry.mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hoseini Abrishami Majid
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 20, Mahdi. 1 Ave., Valiasr Blvd., Gonabad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
96919119735
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
HoseiniAbrishamiM@mums.ac.ir
Web page address
http://dentistry.mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hoseini Abrishami Majid
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 20, Mahdi. 1 Ave., Valiasr Blvd., Gonabad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
96919119735
Phone
+98 51 3882 9502
Fax
+98 51 3882 9500
Email
HoseiniAbrishamiM@mums.ac.ir
Web page address
http://dentistry.mums.ac.ir
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
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
Title and more details about the data/document
--
When the data will become available and for how long
--
To whom data/document is available
--
Under which criteria data/document could be used
--
From where data/document is obtainable
--
What processes are involved for a request to access data/document