Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001129774
Ethics application status
Approved
Date submitted
14/07/2022
Date registered
17/08/2022
Date last updated
23/06/2024
Date data sharing statement initially provided
17/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of virtual reality and aromatherapy on anxiety and pain in patients undergoing dental treatment under local anesthesia.
Scientific title
Effects of virtual reality and aromatherapy on anxiety and pain in adult patients undergoing dental treatment under local anesthesia.
Secondary ID [1] 307574 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 327023 0
Pain 327024 0
Dental anxiety 327025 0
Condition category
Condition code
Mental Health 324197 324197 0 0
Anxiety
Anaesthesiology 324198 324198 0 0
Pain management
Oral and Gastrointestinal 324334 324334 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
INTERVENTION GROUP 1 (VIRTUAL REALITY): In this study, virtual reality glasses from Shinecon® 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.

The images that the patient will be viewing through the virtual reality goggles will be mirrored on another screen to be monitored by the main researcher.

The main researcher will place the virtual reality goggles on the patient and the following procedure will be followed: In the pre-operating room, when the patient is alone, the virtual reality glasses will be delivered 15 minutes before the dental procedure under local anesthesia. After 15 minutes alone and viewing the 3D video, the patient goes to the operating room where the standard dental intervention under local anesthesia is carried out while the patient uses the virtual reality. Finally, the virtual reality goggles will be removed once the procedure is completed.


INTERVENTION GROUP 2 (AROMATHERAPY):

The main researcher will be in charge of placing the diffusers with lavender oil according to the following indications: In this group, while waiting in a room alone, patients will be breathing air with lavender essence for 15 minutes. For this, we will use a diffuser containing 5 drops of lavender oil diluted in 100ml of distilled water. The patient will enter the dental office after these 15 minutes, where there will be another dispenser with the same characteristics. In case the diffuser is exhausted during the intervention, it will be replaced by another of the same characteristics. Once the intervention is finished, the diffuser will be removed from the room immediately.


The type and dose of local anesthesia used in both groups will be decided by the dentist depending on the procedure to be performed.
Intervention code [1] 324027 0
Treatment: Devices
Intervention code [2] 324215 0
Treatment: Other
Comparator / control treatment
The control group will be made up of patients who will undergo different dental procedures under local anesthesia, according to the treatment needed by each of them, with no virtual reality stimulation or lavender oil inhalation will be applied during the procedure. The type and dose of local anesthesia will be decided by the dentist depending on the procedure to be performed.
Control group
Active

Outcomes
Primary outcome [1] 332012 0
Level of perioperative anxiety assessed by the State and Trait Anxiety Inventory (STAI)
Timepoint [1] 332012 0
15 minutes Pre and 15 minutes Post-operative
Primary outcome [2] 332013 0
Level of dental anxiety assessed by the Modified Dental Anxiety Scale (MDAS)
Timepoint [2] 332013 0
15 minutes Pre and 15 minutes Post-operative
Primary outcome [3] 332014 0
Level of perioperative pain assessed by 100 mm Visual Analogue Scale (VAS)
Timepoint [3] 332014 0
Patient will fill in the VAS scale 15 minutes after the intervention, indicating the pain felt DURING the dental procedure
Secondary outcome [1] 411902 0
Analyze the effect of virtual reality and aromatherapy on blood pressure (sphygmomanometer).
Timepoint [1] 411902 0
We collect these parameters: 15 minutes before the dental procedure, immediately after infiltration of local anesthesia and 15 minutes after dental treatment.
Secondary outcome [2] 411903 0
Analyze the effect of virtual reality and aromatherapy on heart rate (pulse oximeter) before, during and after the intervention.
Timepoint [2] 411903 0
We collect these parameters: 15 minutes before the dental procedure, immediately after infiltration of local anesthesia and 15 minutes after dental treatment.
Secondary outcome [3] 411904 0
Analyze the effect of virtual reality and aromatherapy on oxygen saturation (saturometer) before, during and after the intervention.
Timepoint [3] 411904 0
We collect these parameters: 15 minutes before the dental procedure, immediately after infiltration of local anesthesia and 15 minutes after dental treatment.

Eligibility
Key inclusion criteria
(1) patients over 18 years old, (2) patients who required only one extraction per episode, (3) patients which procedures could be performed with local anesthesia exclusively, (4) patients who agreed to participate in the study and had signed the Informed Consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
As for exclusion criteria, the following will be excluded: (1) patients with psychotropic medication or psychiatric treatment, (2) patients with systemic health problems, (3) patients with significant auditory pathology, (4) patients with coagulation disorders, (5) patients undergoing oncological treatment, (6) uncooperative patients, unable to understand the visual analog scale or the anxiety questionnaire, (7) patients with an active infection, (8) pregnant patients.

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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
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 <0.05 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 aromatherapy
(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
5/09/2022
Actual
5/09/2022
Date of last participant enrolment
Anticipated
Actual
22/12/2023
Date of last data collection
Anticipated
Actual
22/12/2023
Sample size
Target
273
Accrual to date
Final
273
Recruitment outside Australia
Country [1] 24894 0
Spain
State/province [1] 24894 0
Almería

Funding & Sponsors
Funding source category [1] 311848 0
Self funded/Unfunded
Name [1] 311848 0
Raúl Romero del Rey
Country [1] 311848 0
Spain
Primary sponsor type
Individual
Name
Raúl Romero del Rey
Address
Calle Santa Bárbara, 3, 04009, Almería (Spain)
Country
Spain
Secondary sponsor category [1] 313323 0
None
Name [1] 313323 0
Address [1] 313323 0
Country [1] 313323 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311289 0
Ethics and Research Commission of the Department of Nursing, Physiotherapy and Medicine of the University of Almeria
Ethics committee address [1] 311289 0
Ethics committee country [1] 311289 0
Spain
Date submitted for ethics approval [1] 311289 0
13/07/2022
Approval date [1] 311289 0
13/07/2022
Ethics approval number [1] 311289 0
EFM 204/2022

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120586 0
Dr Raúl Romero del Rey
Address 120586 0
Clínica Ciudad de Almería, calle Santa Bárbara, 3, 04009, Almería
Country 120586 0
Spain
Phone 120586 0
+34645127620
Fax 120586 0
Email 120586 0
[email protected]
Contact person for public queries
Name 120587 0
Raúl Romero del Rey
Address 120587 0
Clínica Ciudad de Almería, calle Santa Bárbara, 3, 04009, Almería
Country 120587 0
Spain
Phone 120587 0
+34645127620
Fax 120587 0
Email 120587 0
[email protected]
Contact person for scientific queries
Name 120588 0
Raúl Romero del Rey
Address 120588 0
Clínica Ciudad de Almería, calle Santa Bárbara, 3, 04009, Almería
Country 120588 0
Spain
Phone 120588 0
+34645127620
Fax 120588 0
Email 120588 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 dental clinic.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16625Study protocol  [email protected]
16626Ethical approval  [email protected]
16627Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.