Dental AnxietySEREINNCT07273968
Clinical Study Evaluating the Effect of Virtual Reality on Reducing Patients' Anxiety During Wisdom Teeth Extraction
A study testing Virtual reality HypnoVR® (VR headset + hypnotic software) in people with Dental Anxiety and Third Molar Extraction, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dental Anxiety, Third Molar Extraction, Oral Surgery
- What is being tested?
- Virtual reality HypnoVR® (VR headset + hypnotic software)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- Indication for extraction of 4 wisdom teeth or ≥2 mandibular wisdom teeth
- ASA I-II
- Written informed consent.
Who cannot join
- Visual/hearing impairment
- Psychiatric disorders or psychotropics (<8 weeks)
- Claustrophobia
- Heavy smoking >10 cig/day
- Previous radiotherapy (jaw)
- ASA III-IV
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- Pregnancy
- Antithrombotic therapy
- Chemotherapy
- Bisphosphonates
- Uncontrolled diabetes
- Severe anxiety requiring GA or pharmacological sedation
- No health insurance affiliation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Pierre KLIENKOFF
Strasbourg, 67000
Pierre KLIENKOFF, MD, 03 88116768, pierre.klienkoff@chru-strasbourg.fr
About this study
Official title: 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.
- Conditions
- Dental Anxiety, Third Molar Extraction, Oral Surgery
- Being tested
- Virtual reality HypnoVR® (VR headset + hypnotic software), Control Group (No VR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Wisdom tooth extraction under local anesthesia with immersive VR hypnosis (HypnoVR® system). Receives: Device: Virtual reality HypnoVR® (VR headset + hypnotic software) |
| Control Group (No VR) | Active comparator | Wisdom tooth extraction under local anesthesia alone (no VR). Receives: Other: Control Group (No VR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety reduction (MDAS questionnaire)
5-item validated scale, score range 5-25
Measured: Day 1
Anxiety reduction (MDAS questionnaire)
5-item validated scale, score range 5-25
Measured: Month1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start10 Apr 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273968
- Sponsor's protocol ID
- 9832
- Acronym
- SEREIN
- Status last verified
- Aug 2026
- First submitted
- 25 Nov 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Effect of Virtual Reality on Reducing Anxiety in Patients Undergoing Wisdom Teeth Extraction
- ClinicalTrials.gov ID
- NCT07273968
- Acronym / sponsor ID
- SEREIN / 9832
- Conditions
- Dental Anxiety, Third Molar Extraction, Oral Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual reality HypnoVR® (VR headset + hypnotic software)Wisdom tooth extraction under local anesthesia with immersive VR hypnosis (HypnoVR® system). |
| Control Group (No VR) | Active comparator | Other: Control Group (No VR)Wisdom tooth extraction under local anesthesia alone (no VR). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65
- Indication for extraction of 4 wisdom teeth or ≥2 mandibular wisdom teeth
- ASA I-II
- Written informed consent.
Key exclusion criteria (13 listed)
- Visual/hearing impairment
- Psychiatric disorders or psychotropics (<8 weeks)
- Claustrophobia
- Heavy smoking >10 cig/day
- Previous radiotherapy (jaw)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Virtual Reality Group |
| Control Group (No VR)local anesthesia alone (no VR) | Other | Control Group (No VR) |
Primary outcome
Anxiety reduction (MDAS questionnaire)
Time frame: Day 1
5-item validated scale, score range 5-25
Anxiety reduction (MDAS questionnaire)
Time frame: Month1
5-item validated scale, score range 5-25
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality HypnoVR® (VR headset + hypnotic software) in people with Dental Anxiety and Third Molar Extraction, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety reduction (MDAS questionnaire) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.