Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia

Anxiety Clinical Trial

— REVIDEN  

Official title:

Assessment of the Impact of Virtual Reality on Patient Anxiety During Dental Avulsions Under Local Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05963750
• Other study ID #: 21-0188
• Status: Completed
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: July 2023
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fear of the dentist is a very common phenomenon which delays consultations and brings negative consequences on oral and general health. Virtual reality (VR) reduces children's pain and anxiety during dental care or oral surgery. The aim of this prospective, randomized and controlled study is to show the effectiveness of virtual reality to reduce anxiety in a sample of adults during tooth avulsions under local anesthesia. There is a group with virtual reality and a control group without virtual reality. Patients complet the State Trait Anxiety Inventory - State - (STAI-YA) questionnaire and the visual analog anxiety scale (VAS) just before and just after the surgery by transcribing the anxiety they feel during it. The main judgement criterion is the evolution of the STAI-YA score before vs during the surgery. Secondary criteria are the relevance of the chosen metric by comparing it to the VAS, defining the factors influencing the evolution of the anxiety score, studying the side effects of VR and the wish to repeat the experience.

Description:

The virtual reality experience consisted of putting on a headset with music and a 3D helmet on the eyes that broadcast a landscape in motion (a walk). The inclusion took place in the University Hospital of Caen between november 2021 and may 2022. 119 patients were randomized into two groups, one with VR and another one without VR. At the end, 105 patients were analyzed. The main objective was to find a reduction in the STAI-YA score of more than 8 points between before and during the intervention. This analysis was performed in both groups. During the initial consultation, questions were asked about the medical file and informed consent was sought. Patients were then randomised to one of two groups. During the second consultation, a STAI-YA questionnaire and a VAS scale were completed, then the intervention was performed with or without virtual reality, depending on the group, and the STAI-YA questionnaire and the VAS scale were again completed by recalling the stress experienced during the surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (> 18 years old) coming for at least two dental extractions under local anesthesia

Exclusion Criteria:

• patients suffering of motion sickness,
• claustrophobia,
• uncontrolled epilepsy,
• visual impairment,
• hearing disability,
• non-French speakers,
• pregnant women,
• protected adults
• people followed by a psychiatrist whether for depression, bipolarity, schizophrenia
• The day of the intervention, patients who had consumed anxiolytics

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Tooth Avulsion

Intervention

Other:
• virtual reality
virtual reality

Locations

Country	Name	City	State
France	CHU Caen	Caen	Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effectiveness of virtual reality on anxiety (STAI-YA)	The patient completes two anxiety questionnaires (STAI-YA ) before and during the procedure.	Baseline and during the procedure.
Primary	effectiveness of virtual reality on anxiety (Visual Analogue Scale)	The patient completes two anxiety questionnaires (Visual Analogue Scale) before and during the procedure.	Baseline and during the procedure.
Secondary	Comparability of the results with another metric for assessing anxiety	The difference in the visual analogue anxiety scale score between before and during surgery was studied. A reduction of 2cm was sought.	1 day of surgery
Secondary	factors influencing changes in the STAI-YA anxiety score	Using the completed medical records (age, sex, smoking habits, etc.) we looked for any factors influencing the results.	1 day of surgery
Secondary	The wish to renew the virtual reality experience	the question "would you like to repeat the experience for other dental avulsions" was asked to the group who had benefited from virtual reality	1 day of surgery