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

NCT04609956 | Completed

• 1 other identifier: 29BRC20.0107
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

Anxiety, Dental

Keywords

virtual reality; oral surgery; anxiety; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Modified Anxiety Dental Scale (MADS)

  Day 0

• Modified Anxiety Dental Scale (MADS)

  Day 7

Study Arms (2)

virtual reality

EXPERIMENTAL

Experimental arm is a virtual reality headphones

Other: Virtual reality

standard

OTHER

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

Other: Standard

Interventions

Virtual reality OTHER

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

virtual reality

Standard OTHER

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

standard

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, Finistère, 29200, France

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a monocentric interventional prospective comparative randomized study

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: February 16, 2021
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• 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.

Locations

FR (1)