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NCT Number: NCT07273968

Clinical Study Evaluating the Effect of Virtual Reality on Reducing Patients' Anxiety During 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.

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Key information

Conditions

Dental Anxiety Oral Surgery Third Molar Extraction

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pierre KLIENKOFF

Strasbourg, 67000, France

Location status: Recruiting

Location contact

Pierre KLIENKOFF, MD

CONTACT

[email protected]

03 88116768

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Virtual reality HypnoVR® (VR headset + hypnotic software)

Device

CE-marked class I device combining VR immersion with hypnotic text and music therapy to reduce anxiety and pain during oral surgery.

Control Group (No VR)

Other

local anesthesia alone (no VR)

Primary outcomes

  1. Anxiety reduction (MDAS questionnaire)

    Time frame: Day 1

    5-item validated scale, score range 5-25

  2. Anxiety reduction (MDAS questionnaire)

    Time frame: Month1

    5-item validated scale, score range 5-25

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: SEREIN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 10, 2025
Registry last updated
Aug 20, 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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