Clinical Study Evaluating the Effect of Virtual Reality on Reducing Patients' Anxiety During Wisdom Teeth Extraction (SEREIN)

December 8, 2025 updated by: University Hospital, Strasbourg, France

Clinical Study Evaluating the Effect of Virtual Reality on Reducing Anxiety in Patients Undergoing Wisdom Teeth Extraction

Dental anxiety is common during third molar extractions and may exacerbate pain perception. Local anesthesia does not prevent exposure to stress-inducing stimuli. Virtual reality (VR) combined with hypnotic scripts (HypnoVR®) provides immersive multisensory distraction. This study tests whether VR reduces perioperative anxiety and postoperative pain compared to local anesthesia alone.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Age 18-65
  • Indication for extraction of 4 wisdom teeth or ≥2 mandibular wisdom teeth
  • ASA I-II
  • Written informed consent.

Exclusion criteria:

  • Visual/hearing impairment
  • Psychiatric disorders or psychotropics (<8 weeks)
  • Claustrophobia
  • Heavy smoking >10 cig/day
  • Previous radiotherapy (jaw)
  • ASA III-IV
  • Pregnancy
  • Antithrombotic therapy
  • Chemotherapy
  • Bisphosphonates
  • Uncontrolled diabetes
  • Severe anxiety requiring GA or pharmacological sedation
  • No health insurance affiliation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Group
Wisdom tooth extraction under local anesthesia with immersive VR hypnosis (HypnoVR® system).
Device: Virtual reality HypnoVR® (VR headset + hypnotic software)
CE-marked class I device combining VR immersion with hypnotic text and music therapy to reduce anxiety and pain during oral surgery.
Active Comparator: Control Group (No VR)
Wisdom tooth extraction under local anesthesia alone (no VR).
Other: Control Group (No VR)
local anesthesia alone (no VR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety reduction (MDAS questionnaire)
Time Frame: Day 1
5-item validated scale, score range 5-25
Day 1
Anxiety reduction (MDAS questionnaire)
Time Frame: Month1
5-item validated scale, score range 5-25
Month1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9832

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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