SurgeryBRIGANDNCT06589908
Evaluation of the Use of RELAX Glasses on Anxiety of Patients Undergoing Dental Extraction > 2 Teeth, Under Local Anesthesia, Compared With Those Not Using Glasses
A study testing RELAX glasses in people with Surgery, run by Centre Hospitalier de Valenciennes at 1 site in France.
Trial summary
The vast majority of tooth extraction surgery is performed under local anaesthetic, and can be a source of anxiety. In their 2015 article, Appukuttan et al studied the anxiety felt by 1148 patients prior to tooth extraction, and reported up to 82% of patients anxious before a procedure. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- RELAX glasses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 31 Aug 2023to 26 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient undergoing dental extraction > 2 teeth under local anesthesia;
- Over 14 years of age on the day of inclusion;
- Patient with written consent or additional parental consent for minors;
- Socially insured patient;
- Patient willing to comply with all study procedures and duration.
Who cannot join
- Medical history contraindicating RELAX glasses
- Known and current abuse of alcohol and/or illicit drugs that may interfere with patient safety and/or compliance;
- Any condition that would render the patient unfit for the study: current presence of cognitive disorders (MMS < 15), severe psychiatric disorders (bipolar disorders, psychotic disorders according to DSM-V classification);
- Major anxiety requiring preoperative anxiolytics;
- Patient under court protection;
- Patient participating in another study;
- Patient's refusal to use glasses;
- Visually impaired or blind patient.
Trial locations and contacts
1 site in 1 country.
About this study
The vast majority of tooth extraction surgery is performed under local anaesthetic, and can be a source of anxiety. In their 2015 article, Appukuttan et al studied the anxiety felt by 1148 patients prior to tooth extraction, and reported up to 82% of patients anxious before a procedure.
In 2020, Yamashita et al demonstrated the value of virtual reality in reducing patient anxiety during the extraction of three impacted mandibular molars, with no clear effect on the pain felt by the patient.
Read more
The use of a virtual reality headset has been shown to reduce anxiety in dental surgery or in hand surgery under local anesthesia with the WALANT technique. On the other hand, virtual reality and the use of 3D can cause discomfort and side effects such as nausea and dizziness. Audiovisual distraction is also known to be effective in reducing pain and anxiety in patients, with fewer side effects.
The investigators have therefore chosen to use RELAX® eyewear. They wish to study its effect on anxiety, pain and overall patient and surgeon satisfaction.
- Conditions
- Surgery
- Being tested
- RELAX glasses
- Keywords
- audiovisual sedation, anxiety, dental extraction, local anesthesia
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELAX glassesBehavioural
Glasses which are a solution of audiovisual sedation by positiv distraction for hospital medical use
| Study group | Role | What they receive |
|---|---|---|
| Group with RELAX glasses | Experimental | Behavioral : RELAX glasses Glasses which are a solution of audiovisual sedation by positive distraction for hospital medical use Receives: Behavioral: RELAX glasses |
| Group without RELAX glasses | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in visual analogue scale anxiety scores after tooth extraction
The visual analogue anxiety scale from 0 to 10, with meaning no anxiety and 10 very high anxiety
Measured: In the 5 minutes after the end of surgery
Secondary outcomes (6)
Overall satisfaction between the group using RELAX glasses and the group following the usual course (without RELAX glasses) measured by a visual analogue scale
The visual analogue satisfaction scale ranges from 0 to 10, with 0 eaning unsatisfaction and 10indicating very high satisfaction
Measured: Immediative postoperative
Variation in pain between entering and leaving the surgical technical platform between the 2 arms using a visual analogue scale
The visual analogue pain scal range from 0 to 10, with 0 meaning non pain and 10 very high pain
Measured: In the 5 minutes after the end of surgery
Rate of patients receiving at least one analgesic
Measured: After local anesthesia
Surgeon's satisfaction with the feasibility of the procedure in a patient wearing RELAX glasses filling in a self-assessment questionnaire
Self-assessment questionnaire consists of 2 questions :
Assessment of the severity of the operation on a scale of 0 to 10. 0 indicates no severity and 10 extreme severity.
Assessment of patient compliance on a scale from 0 to 10. 0 indicating that the patient was completely compliant and 10 indicating absolutely non-compliant.
Measured: Immediative postoperative
Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score
Only in patients receiving RELAX glasses : if the STAY-IB score is higher than 65, the patient is considered to have pre-existing anxiety
Measured: 7 days (+/-3 days) after surgery
Evaluation of the impact of patient agitation on the operative procedure by filling in a self-assessment questionnaire after each operative procedure.
The questionnary consists of 5 statements. The surgeon must tick only one of them (it's not a scale)
- the patient was not agitated
- The patient was agitated, but this had no impact on the surgical procedure
- Patient agitation caused a change in the surgical procedure
- Patient agitation was the cause of a temporary suspension of the surgical procedure
- The patient's agitation is too great to consider continuing the procedure under local anaesthetic.
Measured: Immediative postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start31 Aug 2023
- Primary completion18 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valenciennes
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589908
- Sponsor's protocol ID
- 2023-02-02
- Acronym
- BRIGAND
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 2 Jul 2025
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of RELAX Glasses on Anxiety of Patients Undergoing Dental Extraction > 2 Teeth, Under Local Anesthesia, Compared With Those Not Using Glasses
- ClinicalTrials.gov ID
- NCT06589908
- Acronym / sponsor ID
- BRIGAND / 2023-02-02
- Conditions
- Surgery
- Keywords
- audiovisual sedation, anxiety, dental extraction, local anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Centre Hospitalier de ValenciennesResearch network
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 19 Sep 2024 (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.
The vast majority of tooth extraction surgery is performed under local anaesthetic, and can be a source of anxiety. In their 2015 article, Appukuttan et al studied the anxiety felt by 1148 patients prior to tooth extraction, and reported up to 82% of patients anxious before a procedure.
In 2020, Yamashita et al demonstrated the value of virtual reality in reducing patient anxiety during the extraction of three impacted mandibular molars, with no clear effect on the pain felt by the patient.
The use of a virtual reality headset has been shown to reduce anxiety in dental surgery or in hand surgery under local anesthesia with the WALANT technique. On the other hand, virtual reality and the use of 3D can cause discomfort and side effects such as nausea and dizziness. Audiovisual distraction is also known to be effective in reducing pain and anxiety in patients, with fewer side effects.
The investigators have therefore chosen to use RELAX® eyewear. They wish to study its effect on anxiety, pain and overall patient and surgeon satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with RELAX glasses | Experimental | Behavioral: RELAX glassesBehavioral : RELAX glasses Glasses which are a solution of audiovisual sedation by positive distraction for hospital medical use |
| Group without RELAX glasses | No intervention | – |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient undergoing dental extraction > 2 teeth under local anesthesia;
- Over 14 years of age on the day of inclusion;
- Patient with written consent or additional parental consent for minors;
- Socially insured patient;
- Patient willing to comply with all study procedures and duration.
Key exclusion criteria (8 listed)
- Medical history contraindicating RELAX glasses
- Known and current abuse of alcohol and/or illicit drugs that may interfere with patient safety and/or compliance;
- Any condition that would render the patient unfit for the study: current presence of cognitive disorders (MMS < 15), severe psychiatric disorders (bipolar disorders, psychotic disorders according to DSM-V classification);
- Major anxiety requiring preoperative anxiolytics;
- Patient under court protection;
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 |
|---|---|---|
| RELAX glassesGlasses which are a solution of audiovisual sedation by positiv distraction for hospital medical use | Behavioural | Group with RELAX glasses |
Primary outcome
Change from baseline in visual analogue scale anxiety scores after tooth extraction
Time frame: In the 5 minutes after the end of surgery
The visual analogue anxiety scale from 0 to 10, with meaning no anxiety and 10 very high anxiety
6 secondary outcomes
Overall satisfaction between the group using RELAX glasses and the group following the usual course (without RELAX glasses) measured by a visual analogue scale
Time frame: Immediative postoperative
Variation in pain between entering and leaving the surgical technical platform between the 2 arms using a visual analogue scale
Time frame: In the 5 minutes after the end of surgery
Rate of patients receiving at least one analgesic
Time frame: After local anesthesia
Surgeon's satisfaction with the feasibility of the procedure in a patient wearing RELAX glasses filling in a self-assessment questionnaire
Time frame: Immediative postoperative
Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score
Time frame: 7 days (+/-3 days) after surgery
Evaluation of the impact of patient agitation on the operative procedure by filling in a self-assessment questionnaire after each operative procedure.
Time frame: Immediative postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RELAX glasses in people with Surgery, run by Centre Hospitalier de Valenciennes 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 2 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in visual analogue scale anxiety scores after tooth extraction (time frame: In the 5 minutes after the end of surgery). 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 2 Jul 2025.