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

NCT ID: NCT04609956

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-16
• Study Completion Date: 2024-05-28

Brief 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)

Detailed 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.

Conditions

Anxiety, Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

virtual reality

Experimental arm is a virtual reality headphones

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: OTHER

Virtual reality consists of a headphones, a virtual reality headset and a smartphone.

standard

Control arm is a usual practice (hydroxyzine + patient music with headphones)

Group Type: OTHER

Standard

Intervention Type: OTHER

Standard arm is the habitual procedure. They use hydroxyzine and music with headphones

Interventions

Virtual reality

Virtual reality consists of a headphones, a virtual reality headset and a smartphone.

Intervention Type: OTHER

Standard

Standard arm is the habitual procedure. They use hydroxyzine and music with headphones

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU de Brest

Brest, Finistère, France

Countries

France

Other Identifiers

29BRC20.0107

Identifier Type: -

Identifier Source: org_study_id