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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Anxiety, Dental
• Intervention / Treatment: Other: Virtual reality; Other: Standard

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sylvie BOISRAME, Ph; Phone Number: 02 98 22 01 95; Email: sylvie.Boisrame@univ-brest.fr

Study Locations

• France
  • Finistère
    • Brest, Finistère, France, 29200
      • Recruiting
      • CHRU de Brest
      • Contact: Sylvie BOISRAME; Phone Number: 02 98 22 01 95; Email: sylvie.boisrame@univ-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virtual reality; Experimental arm is a virtual reality headphones	Other: Virtual reality; Virtual reality consists of a headphones, a virtual reality headset and a smartphone.
Other: standard; Control arm is a usual practice (hydroxyzine + patient music with headphones)	Other: Standard; Standard arm is the habitual procedure. They use hydroxyzine and music with headphones

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Estimated): August 16, 2023
• Study Completion (Estimated): August 16, 2023

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: pain; anxiety; virtual reality; oral surgery
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 29BRC20.0107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No