Virtual Reality Technology on Pain Perception and Anxiety Levels in Adolescents and Young Adults During Third Molar Germ Avulsion Surgery (VIDAMO)

Anxiety, Dental Clinical Trial

— VIDAMO  

Official title:

Comparative Randomized Study of Virtual Reality Technology on Pain Perception and Anxiety Levels in Adolescents and Young Adults During Third Molar Germ Avulsion Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04609956
• Other study ID #: 29BRC20.0107
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2021
• Est. completion date: August 16, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Brest
• Contact: Sylvie BOISRAME, Ph
• Phone: 02 98 22 01 95
• Email: sylvie.Boisrame[@]univ-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For a long time, the fear of the dental surgeon has been the main reason why a percentage of the population avoids regular consultation.

There are many techniques to manage anxiety (tell-show-do, positive reinforcement, live modeling, etc). Now, virtual reality offers this possibility as a non-drug alternative technique.

Few studies have assessed the value of virtual reality in peroperative during an oral surgery procedure.

It is interesting to compare the immediate post-operative anxiety level between groups using virtual reality headset (RV) versus standard protocol (hydroxyzine + music with headphones : SMP)

Description:

Anxiety is defined as a state of psychic disorder caused by fear of danger ; pain as an unpleasant sensory and emotional experience. Although pain and anxiety are subjective sensations, oral cavity care is very much associated with these perceptions.

Thus, the fear of the oral health practitioner (dental surgeon, oral surgeon, maxillofacial surgeon, etc.) is one of the main reasons why a large part of the population does not consult. This real phobia installed in people's imaginary is partly explained by the fact that the mouth is an intimate part of the body. Indeed, according to the Freudian theory, discovery of body and sexuality begins with the oral stage with the oral and esophageal sphere favored as an erogenous zone (supported by the motor activity of sucking). In this way, the oral cavity is a place of love privacy and erotic intimacy, but also a means of communication and a means of recognizing tastes. Regular consultation with a specialist is consequently essential since good oral hygiene is a source of well-being (notions of pleasure, satisfaction).

Oral health practitioners have many solutions in order to reduce patients' apprehension of anxiety and their painful perceptions. In addition to the psychological approach and cognitive-behavioral therapy (tell-show-do, adapt vocabulary, involve the patient in the therapeutic project) ; medical means are available to the practitioner. According to the therapeutic gradient: firstly use of anxiolytics (hydroxyzine) more or less associated with music therapy or other methods of distraction, conscious sedation (Equimolar mixture of Oxygen and Nitrous Oxide - EMONO) and as a last resort general anesthesia.

An alternative non-drug technique has increased : the use of virtual reality (VR). This new technology, recognized for its entertainment value (creation of virtual environments that immerse people in a simulated world) has been extended to other fields including health, particularly for pain and anxiety management.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 16, 2023
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 20 Years

Eligibility

Inclusion Criteria:

• Aged between 14 and 20 years

• Needing one (or more) germ avulsion (s) of the third molars

• With asymptomatic tooth, no signs of infection and germ status

• Affiliated or beneficiary of a social security system

• Have given informed consent or whose consent has been given by one parent

Exclusion Criteria:

• Patients with visual or auditory deficits that contra-indicating the use of the virtual reality headset

• Non-cooperative patients, who do not speak or do not read French fluently, don't understand the principle of a stress scale and collaborate on tests.

• Refusal to participate

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety, Dental

Intervention

Other:
• Virtual reality
Virtual reality consists of a headphones, a virtual reality headset and a smartphone.
• Standard
Standard arm is the habitual procedure. They use hydroxyzine and music with headphones

Locations

Country	Name	City	State
France	CHRU de Brest	Brest	Finistère

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Anxiety Dental Scale (MADS)	For primary outcome, (Modified anxiety dental scale (MADS) is a questionnaire measuring immediate post-operative anxiety. MADS is assessed on a 0 (no stressed) to 25 (very stressed) scale. A score greater than 19 or more corresponds to a very stressed or even phobic patient.	Day 0
Secondary	Modified Anxiety Dental Scale (MADS)	For second outcome, (Modified anxiety dental scale (MADS) is a questionnaire measuring pre-operative anxiety. MADS is assessed on a 0 (no stressed) to 25 (very stressed) scale. A score greater than 19 or more corresponds to a very stressed or even phobic patient.	Day 0
Secondary	Modified Anxiety Dental Scale (MADS)	For second outcome, (Modified anxiety dental scale (MADS) is a questionnaire measuring delay post-operative anxiety.MADS is assessed on a 0 (no stressed) to 25 (very stressed) scale. A score greater than 19 or more corresponds to a very stressed or even phobic patient.	Day 7