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Trial registered on ANZCTR


Registration number
ACTRN12622000384752
Ethics application status
Approved
Date submitted
5/05/2021
Date registered
4/03/2022
Date last updated
4/03/2022
Date data sharing statement initially provided
4/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of virtual reality and music on anxiety and perioperative pain in impacted third molar extraction under local anesthesia.
Scientific title
Effect of virtual reality and music on anxiety and perioperative pain in impacted third molar extraction under local anesthesia in adults.
Secondary ID [1] 304120 0
AGC-LSR-2020-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain 321806 0
anxiety 321807 0
Condition category
Condition code
Surgery 319530 319530 0 0
Other surgery
Anaesthesiology 320940 320940 0 0
Pain management
Mental Health 320941 320941 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTERVNETION GROUP 1 (MUSIC GROUP)
Once the bibliographic search has been carried out and based on the most effective, comfortable studies and with the best results for the patient, it has been proved that there is no clear evidence of which type of music is more beneficial decreasing anxiety, but music determined by patient is preferred. For their use, patients will be given an iPOD®-type electronic acoustic reproduction device with free and unlimited access to Spotify Premium® music application, with wireless headphones headband type (Trust Urban®) (property of the Service of Oral and Maxillofacial Surgery), with pads that improve acoustics and an adjustable headband, which allow individual and isolated listening to the music during the process.

In the pre-operating room, when the patient is alone, the headband-type headset will be delivered 15 minutes before the molar extraction with the music selected by the patient. For the effectiveness of the musical effect, and to avoid the risk or possibility of acoustic damage to the patient, the recommended volume is about 60-70 decibels (db).
After 15 minutes alone listening to music, the patient goes to the operating room where the standard surgical extraction of the lower third molar is performed while the patient uses the music player throughout the surgery. During the surgery, the basic vital signs will be taken again: TAD / TAS, Sat O2 and HR through the same tower with which they were taken in the consultation and in the ante-operating room. These constants will be taken at different times during the surgical procedure: during the infiltration of local anesthetic (articaine with epinephrine 40 / 0.005mg / ml (brand name Ultracain ®)); during mandibulotomy and dental section carried out with a handpiece at 40,000 revolutions with a 23 milling cutter; and after the closure of the flap and placement of local compressive gauze. This procedure may take around 15 minutes

15 minutes after the surgery, the STAI-Y1 questionnaire will be passed again and the basic vital signs will be taken again. And finally, a visual analog scale (VAS) will be used to indicate the perioperative pain experienced by the patient.

INTERVENTION GROUP 2 (VIRTUAL REALITY GROUP)

In this study, virtual reality glasses from Bnext ® (property of Oral and Maxillofacial Surgery service) will be used, these have adjustable straps to the contour of the head to give greater comfort to the patient and allow a prolonged use of them. It also has the ability to adjust the focus and distance that optimize the quality and focus of the image. It has a protection system for the patient's sight, to guarantee their visual safety.

For its use, it is only necessary to insert a compatible smartphone in the front part of the glasses, thus allow to see images in a 360º world where the limit is the imagination.

A 3D video with relaxing images of nature will then be played, along with the relaxing sounds that accompany the 3D images, that allow the patient to disconnect as there is a continuous fusion between listening and visualizing a relaxing situation.

In the same way as in the music intervention group, in the pre-operating room and being unaccompanied, the patient will be provided virtual reality glasses 15 minutes before the intervention.

After 15 minutes alone and viewing the 3D video, the patient goes to the operating room where the standard surgical extraction of the lower third molar is carried out while the patient uses the virtual reality device that will be used throughout the surgery.

During the surgery, the basic vital signs will be taken again: TAD / TAS, Sat O2 and HR through the same tower with which they were taken in the consultation and in the ante-operating room. These constants will be taken at different times during the surgical procedure: during the infiltration of local anesthetic (articaine with epinephrine 40 / 0.005mg / ml (brand name Ultracain ®)); during mandibulotomy and odontosection carried out with a handpiece at 40,000 revolutions with a 23 bur; and after the closure of the flap and placement of local compressive gauze.
15 minutes after the surgery, the STAI-Y1 questionnaire will be passed again and the basic vital signs will be taken again. And finally, a visual analog scale (VAS) will be used to indicate and record the periopertory pain experienced by the patient.
Intervention code [1] 320468 0
Treatment: Devices
Comparator / control treatment
The control group will be made up of patients who will undergo the extraction of the third molar with no musical stimulation or virtual reality will be applied during the surgical procedure.
Control group
Active

Outcomes
Primary outcome [1] 327414 0
Level of perioperative anxiety assessed by the State and Trait Anxiety Inventory (STAI)
Timepoint [1] 327414 0
15 minutes Pre and 15 minutes Post-operative
Primary outcome [2] 328722 0
Level of perioperative pain assessed by 100 mm VAS scale
Timepoint [2] 328722 0
Patient will fill in the VAS scale 15 minutes after the intervention, indicating the pain felt DURING the surgery
Secondary outcome [1] 395010 0
Analyze the effect of music and virtual reality on blood pressure (sphygmomanometer).
Timepoint [1] 395010 0
We collect these parameters: the first time we evaluate the patient (one week before the surgery), 15 minutes before surgery, during the infiltration of local anesthesia, during ostectomy, at the end of the extraction of the third molar, and 15 minutes after surgery.
Secondary outcome [2] 407105 0
Analyze the effect of music and virtual reality on heart rate before, during and after the intervention.
Timepoint [2] 407105 0
We collect these parameters: the first time we evaluate the patient (one week before the surgery), 15 minutes before surgery, during the infiltration of local anesthesia, during ostectomy, at the end of the extraction of the third molar, and 15 minutes after surgery.
Secondary outcome [3] 407106 0
Analyze the effect of music and virtual reality on oxygen saturation (saturometer) before, during and after the intervention.
Timepoint [3] 407106 0
We collect these parameters: the first time we evaluate the patient (one week before the surgery), 15 minutes before surgery, during the infiltration of local anesthesia, during ostectomy, at the end of the extraction of the third molar, and 15 minutes after surgery.

Eligibility
Key inclusion criteria
1. Adult patients between 18-50 years of age, the age range in which tooth eruption generally occurs
2. Both men and women will be selected.
3. Single procedure per surgical act, that is, only one extraction per patient and episode.
4. Procedure performed under exclusive local anesthesia.
5. Patients who have authorized their participation in the clinical trial as well as undergo the surgical removal by signing the Informed Consent.
Minimum age
18 Years
Maximum age
51 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients under 18 years of age or over 51 years of age.
2. Multiple procedure, that is, dental polyextraction in the same surgical act.
3. Patients with deafness or with hearing pathology.
4. Patients who are blind or with significant loss of visual acuity.
5. Patients who suffer from epilepsy or have had an epileptic seizure in the last 6 months.
6. Anticoagulated patients or with bleeding disorders.
7. Patients undergoing cancer treatment or immunosuppressed.
8. Patients being treated with bisphosphonates.
9. Patients with systemic pathology that may interfere with the result.
10. Patients who have received locoregional radiotherapy.
11. Previous surgery in the lower retromolar trigone area.
12. Disabled patients, non-collaborators.
13. Patients unable to understand and fill in the visual analog scale and the anxiety questionnaire.
14. Patients operated under general anesthesia and / or sedation.
15. Presence of active suppurative infection at the time of surgery.
16. Pregnant patients or possibility of pregnancy (verified by pregnancy test).
17. Any medical or surgical condition that, at the discretion of the investigator, puts the patient at risk or that prevents the patient from meeting the requirements of the study or terminating
the same.
18. Patient who does not want or authorize to participate in the study or does not have a correct command or understanding of the Spanish language.
19. Patients with severe cardiac impulse conduction dysfunctions.
20. Patients with decompensated heart failure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The online Randomizer 18 (Research Randomizer, 1997) was used to randomly generate 297 sets of numbers, each of which contained two numbers ranging from 1 to 3 in random order. A total of 273 unique codes were generated based on the 91 sets of {1, 2 and 3} (eg Set1Group1, Set1Group2, Set1Group3) and placed in a box. After signing the consent, a code was randomly chosen for each patient, to ensure that the 273 patients were equally distributed into three groups according to the group number of each code: group 1 (experimental group 1), group 2 (experimental group 2) and group 3 (control group).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The average number of patients operated on with impacted lower wisdom teeth per month during the study period was 65. Every Monday afternoon, during the study period, 10-12 patients will be operated on. Patients meeting the selection criteria were recruited and agreed to participate in the study. Before beginning the study, the online Randomizer 18 (Research Randomizer, 1997) was used to randomly generate 297 sets of numbers, each of which contained two numbers ranging from 1 to 3 in random order. A total of 297
Unique codes were generated based on the 91 sets of {1, 2, and 3} (eg Set1Group1, Set1Group2, Set1Group3) and placed in a box. After signing the consent, a code was randomly chosen for each patient, to ensure that the 297 patients were equally distributed into three groups according to the group number of each code: group 1 (experimental group 1), group 2 (experimental group 2) and group 3 (control group).

With all the variables described, a database will be prepared and their statistical treatment will be carried out with the SPSS 22.0 program.

Univariate or descriptive analysis will be performed. For qualitative variables, frequencies with their corresponding percentages will be calculated and for quantitative variables, measures of central tendency and dispersion measures (mean, minimum, maximum and standard deviation) will be performed.
In the bivariate analysis, for the comparison of qualitative variables, the Chi-square test will be applied, considering a value of p <0.005 to be significant. For the comparison of means of quantitative variables, after a normality test (Kolmogorov-Smirnov Test), parametric or non-parametric tests will be applied, as appropriate, for variables with normal distribution, the T-Student test will be used for independent variables, T-Student test for paired variables and one-way ANOVA with their corresponding “post hot” tests, for variables that do not follow a non-normal distribution, Mann-Whitney U test to compare independent variables, Wincoxon test for paired variables , Kruskal-Wallis for more than two independent variables, and the Friedman test for more than two paired variables.

Multivariate analysis will be performed using binary logistic regression, using musical intervention (yes / no) or virtual reality (yes / no) as the dependent variable and all those that were considered to have influenced the model as independent variables. The Hosmer-Lemeschow goodness of fit test and a statistical significance of p <0.05 will be performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2020
Date of last participant enrolment
Anticipated
Actual
28/04/2021
Date of last data collection
Anticipated
Actual
28/04/2021
Sample size
Target
273
Accrual to date
Final
280
Recruitment outside Australia
Country [1] 23673 0
Spain
State/province [1] 23673 0
Almeria

Funding & Sponsors
Funding source category [1] 308499 0
Hospital
Name [1] 308499 0
Hospital Universitario Torrecárdenas
Country [1] 308499 0
Spain
Primary sponsor type
Individual
Name
Ana Rocío García Carricondo
Address
Avenida Torrecardenas, 3P
04009, Almería (Almería)
Spain
Country
Spain
Secondary sponsor category [1] 309350 0
None
Name [1] 309350 0
Address [1] 309350 0
Country [1] 309350 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308459 0
COMITE DE ETICA DE LA INVESTIGACION DE ALMERIA
Ethics committee address [1] 308459 0
Calle Hermandad de Donantes de Sangre, s/n, 04009 Almería
Ethics committee country [1] 308459 0
Spain
Date submitted for ethics approval [1] 308459 0
10/02/2020
Approval date [1] 308459 0
27/03/2020
Ethics approval number [1] 308459 0

Summary
Brief summary
Procedures with local anesthesia are very prevalent in the medical field, representing the most frequent surgical procedure in Oral and Maxillofacial Surgery Services, and it is widely known that, especially the interventions in our field and dentistry, are situations experienced as a moment of stress, fear and anxiety for the patient, which is why there is interest in finding and applying non-invasive therapies, with the aim of attenuating and improving these undesirable states.

Music therapy and virtual reality are disciplines that are increasingly studied and growing in the field of medicine, especially in areas aimed at controlling pain and anxiety, to ensure better comfort for the patient who undergoes invasive procedures.

The objective of the work is to evaluate the role of virtual reality and music in reducing anxiety and perioperative pain in the surgical extraction of impacted third molars under local anesthesia.

For this, a controlled parallel group clinical trial (RCT) has been proposed, with three groups: experimental 1 (91 patients) who will undergo surgical extraction of the third molar receiving musical stimulation during the surgical procedure. Experimental group 2 (91 patients) to whom virtual reality will be applied during the surgical procedure. And control group (91 patients) who will be the patients who will have the third molar extracted without receiving musical stimulation or virtual reality during the surgical procedure.

The variables to be studied will be: the evaluation of anxiety and pain in all the subjects that make up the three arms of the trial, being evaluated using the Trait and State anxiety questionnaire (STAI) and the numerical visual analogue scale (VAS). And epidemiological variables such as age, sex, dental laterality, degree of inclusion, variation in basic vital signs (HR, Sat O2, TA).

Music therapy and virtual reality can provide new knowledge in medical practice and become a resource for the control of anxiety and pain in patients undergoing oral surgery; offering the healthcare professional non-pharmacological or invasive tools that will enable them to provide holistic and comprehensive care to the user, improving their comfort and quality of care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110762 0
Dr ANA ROCIO GARCIA CARRICONDO
Address 110762 0
Servicio de Cirugía Oral y Maxilofacial. Hospital Universitario Torrecárdenas. Calle Hermandad de Donantes de Sangre s/n, 04009, Almería, Almería (Spain)
Country 110762 0
Spain
Phone 110762 0
+34625088560
Fax 110762 0
Email 110762 0
[email protected]
Contact person for public queries
Name 110763 0
LAURA SORRIBES DE RAMON
Address 110763 0
Avenida Albufereta, 32. 03016 Alicante, Alicante (Spain)
Country 110763 0
Spain
Phone 110763 0
+34670567071
Fax 110763 0
Email 110763 0
[email protected]
Contact person for scientific queries
Name 110764 0
LAURA SORRIBES DE RAMON
Address 110764 0
Avenida Albufereta, 32. 03016 Alicante, Alicante (Spain)
Country 110764 0
Spain
Phone 110764 0
+34670567071
Fax 110764 0
Email 110764 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data is confidential and must remain only in the hospital


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Results publications and other study-related documents

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