The effect of music therapy and virtual reality in creating distraction and reducing pain perception during anesthesia injection in patients referred to the endo ward of Isfahan University of Medical Sciences
Design
Group A: Virtual Reality Group
Group B: Music therapy group
Group C: Control group
Blinding of samples to record pain using VAS (Appendix) is done in such a way that after injecting VR or mp3 player is taken from the patient and the project partner who does not know the intervention method to record VAS (0-10) (Appendix) Refer and register it. Then the collected information is entered into the statistical software Spss version 22. Statistical data analysis in terms of descriptive calculation of mean and standard deviation and drawing of bar and box diagrams, and analytically in case of necessary conditions for one-way analysis of variance and Tukey multiple comparisons, and otherwise Kruskal-Wallis parametric bread test and I will be Whitney.
Settings and conduct
Patients referred to the endodontics department of the School of Dentistry of Isfahan University of Medical Sciences
Blinding of samples to record pain using VAS (Appendix) is done in such a way that after injecting VR or mp3 player is taken from the patient and the project partner who does not know the intervention method to record VAS (0-10) (Appendix) Refer and register it
Participants/Inclusion and exclusion criteria
18-40 years old, consent to participate in the study, non-pregnant patients, patients undergoing local anesthesia, patients with negative percussion test and normal periapical and without periodontal disease. No smoking, nicotine and alcohol
Intervention groups
Group A: Virtual Reality Group
Group B: Music therapy group
Group C: Control group
Main outcome variables
VAS score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046277N2
Registration date:2021-09-08, 1400/06/17
Registration timing:retrospective
Last update:2021-09-08, 1400/06/17
Update count:0
Registration date
2021-09-08, 1400/06/17
Registrant information
Name
ali ghazalgoo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5547
Email address
alighazalgoo@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-16, 1400/05/25
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of music therapy and virtual reality on the amount of pain during anesthesia injection
Public title
Investigating the effect of music and virtual reality on pain during anesthesia injection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-40 years
patients who are willing to participate in the study,
No hearing or vision problems
no diseases such as heart problems and other advanced systemic diseases
non-pregnant patient
Patients who do not smoke, nicotine or alcohol
Patients admitted to the general ward of the facult
Patients with negative pericardial test and normal periapical and without periodontal disease
no history of anesthesia injection in the anterior maxilla
Exclusion criteria:
The need for more complex treatment in the specialized department
Patients with immunodeficiency or hypertension
Patients who refuse to continue treatment and cooperation
Age
From 18 years old to 40 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
Patients were randomly assigned the number 1-30 to men. 31-60 We group women with a random number application in such a way that:
If the number 1-10 or 31-40 comes, they are in group A.
If the number 11-20 comes with 41-50, they are in group B.
If the numbers are 21-30 or 51-60, they are in group C.
The random number application is such that without human intervention, we give the application a range of 1 to 30, for example, and select a number for each patient. Which group should we be in?
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding of samples to record pain using VAS (Appendix) is done in such a way that after injecting VR or mp3 player is taken from the patient and the project partner who does not know the intervention method to record VAS (0-10) (Appendix) Refer and register it.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Pain score in the patient-filled VAS questionnaire
Timepoint
Measuring the amount of pain during anesthesia injection at the end of the injection
Method of measurement
Patient-filled VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who wear IMV260 Personal Eyewear Cinema VR glasses on their face during anesthesia injection and the selected video is played for 5 minutes before the injection and until the end of the injection.
Category
Prevention
2
Description
Intervention group: Group B: Patients whose favorite music is played with the headphone and mp3 player 5 minutes before the injection until the end of the injection.
Category
Prevention
3
Description
Control group: Group C: Patients for whom no intervention is performed during anesthesia injection.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry Isfahan University of Medical Sciences
Full name of responsible person
Ali Ghazalgoo
Street address
Isfahan, Shohada Sofeh St., Isfahan University of Medical Sciences, School of Dentistry
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 21 3792 5511
Email
AliGhazalgoo@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nakisa Torabinia
Street address
Isfahan, Shohada Sofeh St., Isfahan University of Medical Sciences, School of Dentistry
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5512
Email
Torabinia@dnt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ali Ghazalgoo
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Abbas abad Ave , golha bonbast
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5547
Fax
Email
alighazalgoo@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Ghazalgoo
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Abbas abad Ave , golha bonbast
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5547
Fax
Email
alighazalgoo@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Ghazalgoo
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Abbas abad Ave , golha bonbast
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5547
Fax
Email
alighazalgoo@yahoo.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
The patient's personal details are not required
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
Yes - There is 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
The patient's personal details are not required
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In case of research on a similar subject, she can use the data of this research.
From where data/document is obtainable
Dr. Ali Ghazalgoo with e-mail address: Alighazalgoo@yahoo.com
What processes are involved for a request to access data/document
Correspond with Dr. Ali Ghazalgoo by e-mail and receive the data at her discretion