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Completed

NCT Number: NCT05963750

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Caen

Caen, Normandy, 14000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality

Other

virtual reality

Primary outcomes

  1. effectiveness of virtual reality on anxiety (STAI-YA)

    Time frame: Baseline and during the procedure.

    The patient completes two anxiety questionnaires (STAI-YA ) before and during the procedure.

  2. effectiveness of virtual reality on anxiety (Visual Analogue Scale)

    Time frame: Baseline and during the procedure.

    The patient completes two anxiety questionnaires (Visual Analogue Scale) before and during the procedure.

Secondary outcomes

  1. Comparability of the results with another metric for assessing anxiety

    Time frame: 1 day of surgery

    The difference in the visual analogue anxiety scale score between before and during surgery was studied. A reduction of 2cm was sought.

  2. factors influencing changes in the STAI-YA anxiety score

    Time frame: 1 day of surgery

    Using the completed medical records (age, sex, smoking habits, etc.) we looked for any factors influencing the results.

  3. The wish to renew the virtual reality experience

    Time frame: 1 day of surgery

    the question "would you like to repeat the experience for other dental avulsions" was asked to the group who had benefited from virtual reality

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: REVIDEN

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 27, 2023
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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