Dental AnxietyHYPNOSEDENTNCT05167331
Comparative Clinical Study Between Virtual Reality Hypnosis and Nitrous Oxide Inhalation for Dental Anxie
A study testing Nitrous Oxide inhalation and Dispositif de RV - HYPNO VR in people with Dental Anxiety, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The vicious circle of dental anxiety impacts major aspects of a child's quality of life. Hypnosis using distraction is one of the most common non-pharmalogical techniques in behavior and pain management in pediatric dentistry. Its value over traditional pharmalogical sedation is undeniable. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Nitrous Oxide inhalation and Dispositif de RV - HYPNO VR
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2022to 12 Nov 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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged between 7 and 10 years
- With an indication for conservative and/or endodontic care of at least 2 temporary molars belonging to the same dental arch, unilateral or bilateral, and equivalent in terms of caries and symptoms
- With dental anxiety
- ASA I patients
Who cannot join
- Patient with a history of MEOPA or virtual reality sedation for dental treatment
- Patient refusing to do preoperative intra-oral x-rays
- Patient with one of the MEOPA contraindications
- Patient with a history of post-operative nausea vomiting or motion sickness
- Patient with visual or hearing disorders
- Patient presenting with a psychiatric pathology or having taken psychotropic drugs in the 8 weeks preceding the 1st visit and during the duration of the study
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- Patient with claustrophobia
- Patient without French Social Security coverage
- Lack of consent from the holders of parental authority to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Virtual Reality Hypnosis Versus Nitrous Oxide Inhalation on Children's Anxiety During a Dental Treatment : a Randomized Clinical Trial
The vicious circle of dental anxiety impacts major aspects of a child's quality of life. Hypnosis using distraction is one of the most common non-pharmalogical techniques in behavior and pain management in pediatric dentistry. Its value over traditional pharmalogical sedation is undeniable. This clinical study examines the application of hypnosis delivered through immersive virtual reality (VR) for anxious children ongoing dental procedures. The investigators will explore whether VR is as effective on pain and anxiety relief as a pharmacological sedation with inhalation of nitrous oxide.
Read the detailed description
The working hypothesis of this study is that hypnosis through virtual reality can reduce children's anxiety as well as their pain level during dental care with an efficiency and tolerance at least similar to nitrous oxide inhalation. Specifically, the statistical analyses will be based on an assumption of non-inferiority of VR compared to the pharmacological technique of nitrous oxide sedation.
Each patient (aged from 6 to 10) attended for two visits in order to benefit of 2 similar conservative dental treatments on primary molars.
Everyone was randomly allocated to receive hypnosis through virtual reality or nitrous oxide/oxygen titrated to 50%/50% at the first visit, the alternative being used at the second visit. This randomization helps avoid any experimental bias related to a first positive or negative experience, each patient being its own control.
Vital signs and a video of the child's behavior are recorded for an external examinator. The video shows the child's body response as an indicator for his anxiety level through the procedures. The child's face doesn't appear on the video in order to reduce risks of bias.
- Conditions
- Dental Anxiety
- Being tested
- Nitrous Oxide inhalation, Dispositif de RV - HYPNO VR
- Keywords
- virtual reality, hypnosis, nitrous oxide, dental anxiety, child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous Oxide inhalationDrug
use of Nitrous Oxide inhalation on children's anxiety during a dental treatment
Dispositif de RV - HYPNO VRDevice
use of Virtual Reality on children's anxiety during a dental treatment
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Active comparator | * (T1) after fitting the headset to the child's face, the assistant starts the VR program chosen by the child.
* (T2) Five minutes after induction, local anesthesia with the QUICKSLEEPER device is performed. The injection of a cartridge of anesthetic Articaïne SEPTANEST 1/200 000 is administered intraosseously.
* (T3) After placing the rubber dam, the investigator performs restorative +/- endodontic care of the selected temporary molar.
* (T4) Once the treatment is finished, the sedation is stopped and the patient rests in the chair for 5 minutes.
* (T5) As soon as the investigator considers that the child is back to normal state, he can leave the office with his parents. Receives: Device: Dispositif de RV - HYPNO VR |
| Nitrous oxide sedation | Active comparator | * (T1) With the nitrous oxide/oxygen inhalation system titrated to 50%/50% whose flow rate is adapted to the child's respiratory flow. The assistant is responsible for controlling the sedation. Verbal encouragement is always present to reassure the child.
* (T2) Five minutes after induction, local anesthesia with the QUICKSLEEPER device is performed. The injection of a cartridge of anesthetic Articaïne SEPTANEST 1/200 000 is administered intraosseously.
* (T3) After placing the rubber dam, the investigator performs restorative +/- endodontic care of the selected temporary molar.
* (T4) Once the treatment is finished, the sedation is stopped and the patient rests in the chair for 5 minutes.
* (T5) As soon as the investigator considers that the child is back to normal state, he can leave the office with his parents. Receives: Drug: Nitrous Oxide inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiolysis assessed by a standardized hetero-assessment scale (Venham Modified Scale)
Child behavior can be assessed using the Veerkamp Modified Venham Scale (VMS). This is a scale from 0 (completely calm and relaxed patient) to 5 (distressed patient, completely disconnected). Several parameters are taken into account in this scale such as: the child's movements, crying or screaming, the possibility or not of performing the treatment. The authors have found this scale to be a reliable, easy-to-use and reproducible instrument when it comes to assessing children's behavior.
This outcome measure is assessed by an external examinator with the video recording the procedures.
Measured: 5 weeks
Secondary outcomes (3)
Assessment of analgesia with VR
Assessment of analgesia using self-assessed pain levels on standardized age-appropriate scales (VAS: Visual Analogue Scale)
Measured: 5 weeks
Assessment of children's tolerance levels to VR and pharmacological technique.
Assessment of tolerance and response to VR-MEOPA using the number and proportion of patients intolerant to VR and to pharmacological techniques. Evaluate the proportion of VR or MEOPA sessions interrupted (lack of therapeutic continuity). Any patient who has interrupted VR more than once or who refused VR during the procedure is considered intolerant of VR.
Measured: 5 weeks
Assessment of the impact of the child's temperament on his acceptance of nitrous oxide and RV sedations using a questionnaire and a temperament scale
To assess the child's temperament dimensions, parents answer to an Emotionality, Activity and Sociability questionnaire with the help of an investigator before the treatment session. The AES questionnaire had already been validated in France in children aged from 6 to 12 years-old in 2002. The AES questionnaire is a questionnaire containing 25 items based on a model of three main dimensions: Emotionality, Activity and Sociability. Each item has a Likert-type scale ranging from 1 (extremely false, not at all corresponding to my child) to 5 (extremely fair, corresponding to my child).
Measured: The parents answer to the questionnaire on the first visit during inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start10 Feb 2022
- Primary completion12 Nov 2024
- Study completion12 Nov 2024
Why it stopped: inclusion challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
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
- NCT05167331
- Sponsor's protocol ID
- 8113
- Acronym
- HYPNOSEDENT
- Status last verified
- Feb 2026
- First submitted
- 25 Nov 2021
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Do NM, Maniere MC, Lefebvre F, Clauss F. Efficacy of virtual reality hypnosis versus conscious sedation with nitrous oxide in the management of dental anxiety in pediatric dentistry: protocol for a prospective randomized controlled trial. Trials. 2025 Jun 9;26(1):201. doi: 10.1186/s13063-025-08849-z.
PubMed 40490788
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Reality Hypnosis Versus Nitrous Oxide Inhalation on Children's Anxiety During a Dental Treatment : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05167331
- Acronym / sponsor ID
- HYPNOSEDENT / 8113
- Conditions
- Dental Anxiety
- Keywords
- virtual reality, hypnosis, nitrous oxide, dental anxiety, child
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion challenges
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 22 Dec 2021 (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 vicious circle of dental anxiety impacts major aspects of a child's quality of life. Hypnosis using distraction is one of the most common non-pharmalogical techniques in behavior and pain management in pediatric dentistry. Its value over traditional pharmalogical sedation is undeniable. This clinical study examines the application of hypnosis delivered through immersive virtual reality (VR) for anxious children ongoing dental procedures. The investigators will explore whether VR is as effective on pain and anxiety relief as a pharmacological sedation with inhalation of nitrous oxide.
Detailed description
The working hypothesis of this study is that hypnosis through virtual reality can reduce children's anxiety as well as their pain level during dental care with an efficiency and tolerance at least similar to nitrous oxide inhalation. Specifically, the statistical analyses will be based on an assumption of non-inferiority of VR compared to the pharmacological technique of nitrous oxide sedation.
Each patient (aged from 6 to 10) attended for two visits in order to benefit of 2 similar conservative dental treatments on primary molars.
Everyone was randomly allocated to receive hypnosis through virtual reality or nitrous oxide/oxygen titrated to 50%/50% at the first visit, the alternative being used at the second visit. This randomization helps avoid any experimental bias related to a first positive or negative experience, each patient being its own control.
Vital signs and a video of the child's behavior are recorded for an external examinator. The video shows the child's body response as an indicator for his anxiety level through the procedures. The child's face doesn't appear on the video in order to reduce risks of bias.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Active comparator | Device: Dispositif de RV - HYPNO VR* (T1) after fitting the headset to the child's face, the assistant starts the VR program chosen by the child. * (T2) Five minutes after induction, local anesthesia with the QUICKSLEEPER device is performed. The injection of a cartridge of anesthetic Articaïne SEPTANEST 1/200 000 is administered intraosseously. * (T3) After placing the rubber dam, the investigator performs restorative +/- endodontic care of the selected temporary molar. * (T4) Once the treatment is finished, the sedation is stopped and the patient rests in the chair for 5 minutes. * (T5) As soon as the investigator considers that the child is back to normal state, he can leave the office with his parents. |
| Nitrous oxide sedation | Active comparator | Drug: Nitrous Oxide inhalation* (T1) With the nitrous oxide/oxygen inhalation system titrated to 50%/50% whose flow rate is adapted to the child's respiratory flow. The assistant is responsible for controlling the sedation. Verbal encouragement is always present to reassure the child. * (T2) Five minutes after induction, local anesthesia with the QUICKSLEEPER device is performed. The injection of a cartridge of anesthetic Articaïne SEPTANEST 1/200 000 is administered intraosseously. * (T3) After placing the rubber dam, the investigator performs restorative +/- endodontic care of the selected temporary molar. * (T4) Once the treatment is finished, the sedation is stopped and the patient rests in the chair for 5 minutes. * (T5) As soon as the investigator considers that the child is back to normal state, he can leave the office with his parents. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients aged between 7 and 10 years
- With an indication for conservative and/or endodontic care of at least 2 temporary molars belonging to the same dental arch, unilateral or bilateral, and equivalent in terms of caries and symptoms
- With dental anxiety
- ASA I patients
Key exclusion criteria (9 listed)
- Patient with a history of MEOPA or virtual reality sedation for dental treatment
- Patient refusing to do preoperative intra-oral x-rays
- Patient with one of the MEOPA contraindications
- Patient with a history of post-operative nausea vomiting or motion sickness
- Patient with visual or hearing disorders
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 |
|---|---|---|
| Nitrous Oxide inhalationuse of Nitrous Oxide inhalation on children's anxiety during a dental treatment | Drug | Nitrous oxide sedation |
| Dispositif de RV - HYPNO VRuse of Virtual Reality on children's anxiety during a dental treatment | Device | Virtual Reality |
Primary outcome
Anxiolysis assessed by a standardized hetero-assessment scale (Venham Modified Scale)
Time frame: 5 weeks
Child behavior can be assessed using the Veerkamp Modified Venham Scale (VMS). This is a scale from 0 (completely calm and relaxed patient) to 5 (distressed patient, completely disconnected). Several parameters are taken into account in this scale such as: the child's movements, crying or screaming, the possibility or not of performing the treatment. The authors have found this scale to be a reliable, easy-to-use and reproducible instrument when it comes to assessing children's behavior. This outcome measure is assessed by an external examinator with the video recording the procedures.
3 secondary outcomes
Assessment of analgesia with VR
Time frame: 5 weeks
Assessment of children's tolerance levels to VR and pharmacological technique.
Time frame: 5 weeks
Assessment of the impact of the child's temperament on his acceptance of nitrous oxide and RV sedations using a questionnaire and a temperament scale
Time frame: The parents answer to the questionnaire on the first visit during inclusion.
Results and safety
The study was stopped early (reason given: inclusion challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 40490788Do NM, Maniere MC, Lefebvre F, Clauss F. Efficacy of virtual reality hypnosis versus conscious sedation with nitrous oxide in the management of dental anxiety in pediatric dentistry: protocol for a prospective randomized controlled trial. Trials. 2025 Jun 9;26(1):201. doi: 10.1186/s13063-025-08849-z.
- Individual participant dataSharing planned: Undecided
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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 Nitrous Oxide inhalation and Dispositif de RV - HYPNO VR in people with Dental Anxiety, 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 9 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: stopped early, as of the sponsor's last update on 8 Jun 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?
The study was stopped early (reason given: inclusion challenges). Results are not available in the source record.
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?
Anxiolysis assessed by a standardized hetero-assessment scale (Venham Modified Scale) (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05167331, which also lists 1 linked publication.
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 8 Jun 2026.