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

Primary Purpose

Anxiety, Dental

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality
Standard
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety, Dental focused on measuring virtual reality, oral surgery, anxiety, pain

Eligibility Criteria

14 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHRU de BrestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

virtual reality

standard

Arm Description

Experimental arm is a virtual reality headphones

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 26, 2020
Last Updated
July 11, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT04609956
Brief Title
Virtual Reality Technology on Pain Perception and Anxiety Levels in Adolescents and Young Adults During Third Molar Germ Avulsion Surgery (VIDAMO)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
August 16, 2023 (Anticipated)
Study Completion Date
August 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Dental
Keywords
virtual reality, oral surgery, anxiety, pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a monocentric interventional prospective comparative randomized study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
virtual reality
Arm Type
Experimental
Arm Description
Experimental arm is a virtual reality headphones
Arm Title
standard
Arm Type
Other
Arm Description
Control arm is a usual practice (hydroxyzine + patient music with headphones)
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
Virtual reality consists of a headphones, a virtual reality headset and a smartphone.
Intervention Type
Other
Intervention Name(s)
Standard
Intervention Description
Standard arm is the habitual procedure. They use hydroxyzine and music with headphones
Primary Outcome Measure Information:
Title
Modified Anxiety Dental Scale (MADS)
Description
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.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Modified Anxiety Dental Scale (MADS)
Description
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.
Time Frame
Day 0
Title
Modified Anxiety Dental Scale (MADS)
Description
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.
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvie BOISRAME, Ph
Phone
02 98 22 01 95
Email
sylvie.Boisrame@univ-brest.fr
Facility Information:
Facility Name
CHRU de Brest
City
Brest
State/Province
Finistère
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie BOISRAME
Phone
02 98 22 01 95
Email
sylvie.boisrame@univ-brest.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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