Odontologic DisordersIISLANCT06776653
Impact of a Snoezelen Element on Anxiety in Patients During Oral Care: A Real-Life Study at Nantes University Hospital
An observational study of Odontologic Disorders, run by Nantes University Hospital at 1 site in France.
Trial summary
Research on dental phobia highlights both external causes, like traumatic experiences or media influence, and internal factors, such as genetics and personality traits. While many studies focus on technical aspects of dental care, few explore how the care environment affects patient anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Odontologic Disorders
- What is being tested?
- Tovertafel Pixie
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2025to 15 Mar 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients consulting the specialized care unit of the dentistry department at Hôtel-Dieu University Hospital in Nantes, capable of understanding the various questions independently or with the assistance of a trusted person
Who may be able to join
- Adult patient, over 18 years old;
- consulting in the specialized care unit;
- who understands French;
- receiving care in the specialized dentistry unit and capable of expressing themselves independently regarding the various items in the questionnaire, whether orally, in writing, through a speech synthesis system, or using pictograms;
- able to provide consent to participate.
Who cannot join
- receiving care in the specialized care unit who are unable to express themselves independently regarding the various items in the questionnaire, whether orally, in writing, through a speech synthesis system, or using pictograms;
- refuse to participate in the study;
- under guardianship, curatorship, or legal protection.
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
CHU Nantes-Department of Dentistry
Nantes, Nantes, 44000
Alexandra Poinas, PhD, +33 2 40 08 33 33, alexandra.poinas@chu-nantes.fr
About this study
Official title: Impact of a Snoezelen Element on Anxiety in Patients With Special Needs During Oral Care at the Hôtel-Dieu University Hospital in Nantes: A Real-Life Study at Nantes University Hospital
Research on dental phobia highlights both external causes, like traumatic experiences or media influence, and internal factors, such as genetics and personality traits. While many studies focus on technical aspects of dental care, few explore how the care environment affects patient anxiety.
The Snoezelen concept, developed in the 1970s, uses sensory stimulation (sight, sound, smell, and touch) to reduce anxiety. Initially designed for individuals with neurocognitive disorders, it creates a calming environment and has since been adopted in various healthcare settings.
At Nantes University Hospital, the dental department will test the Tovertafel Pixie®, a sensory projector designed to distract patients and reduce anxiety. Its mobility allows it to be used in waiting rooms and treatment areas, projecting onto ceilings, walls, or tables. This real-life study will assess whether patients exposed to the projector experience less anxiety compared to those who are not, with the goal of improving patient care and dental treatment experiences.
Read the detailed description
The study involves a questionnaire that the dental department usually provide to our patients, which is partially completed by the patient and partially by the practitioner at the end of the treatment session. No follow-up visit is required.
- Conditions
- Odontologic Disorders
- Being tested
- Tovertafel Pixie
- Medical subject headings
- Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tovertafel PixieOther
The Tovertafel Pixie® projector has a distracting effect, which can help divert the patient's attention while waiting for or undergoing treatment.
| Study group | Role | What they receive |
|---|---|---|
| Tovertafel Pixie | Patients who will have the Tovertafel Pixie in the waiting room and the consultation room Receives: Other: Tovertafel Pixie | |
| controle | Patients without the Tovertafel Pixie in the waiting room and the consultation room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of anxiety.
The Kleinknecht Dental Fear Survey (DFS) measures dental anxiety on a scale ranging from 20 (minimum) to 100 (maximum), where higher scores indicate greater levels of fear or anxiety - Comparison of means
Measured: 1 day
Secondary outcomes (1)
Measure the waiting time in the waiting room
Measure the waiting time in the waiting room in minutes
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start15 Jan 2025
- Primary completion15 Feb 2025
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Odontologic DisordersStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Hyon, M.D, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776653
- Sponsor's protocol ID
- AP_IH_IISLA_01
- Acronym
- IISLA
- Status last verified
- Jun 2026
- First submitted
- 20 Dec 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Snoezelen Element on Anxiety in Patients With Special Needs During Oral Care at the Hôtel-Dieu University Hospital in Nantes: A Real-Life Study at Nantes University Hospital
- ClinicalTrials.gov ID
- NCT06776653
- Acronym / sponsor ID
- IISLA / AP_IH_IISLA_01
- Conditions
- Odontologic Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 15 Jan 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.
Research on dental phobia highlights both external causes, like traumatic experiences or media influence, and internal factors, such as genetics and personality traits. While many studies focus on technical aspects of dental care, few explore how the care environment affects patient anxiety.
The Snoezelen concept, developed in the 1970s, uses sensory stimulation (sight, sound, smell, and touch) to reduce anxiety. Initially designed for individuals with neurocognitive disorders, it creates a calming environment and has since been adopted in various healthcare settings.
At Nantes University Hospital, the dental department will test the Tovertafel Pixie®, a sensory projector designed to distract patients and reduce anxiety. Its mobility allows it to be used in waiting rooms and treatment areas, projecting onto ceilings, walls, or tables. This real-life study will assess whether patients exposed to the projector experience less anxiety compared to those who are not, with the goal of improving patient care and dental treatment experiences.
Detailed description
The study involves a questionnaire that the dental department usually provide to our patients, which is partially completed by the patient and partially by the practitioner at the end of the treatment session. No follow-up visit is required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tovertafel Pixie | – | Other: Tovertafel PixiePatients who will have the Tovertafel Pixie in the waiting room and the consultation room |
| controle | – | –Patients without the Tovertafel Pixie in the waiting room and the consultation room |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients consulting the specialized care unit of the dentistry department at Hôtel-Dieu University Hospital in Nantes, capable of understanding the various questions independently or with the assistance of a trusted person
Key inclusion criteria (5 listed)
- Adult patient, over 18 years old;
- consulting in the specialized care unit;
- who understands French;
- receiving care in the specialized dentistry unit and capable of expressing themselves independently regarding the various items in the questionnaire, whether orally, in writing, through a speech synthesis system, or using pictograms;
- able to provide consent to participate.
Key exclusion criteria (3 listed)
- receiving care in the specialized care unit who are unable to express themselves independently regarding the various items in the questionnaire, whether orally, in writing, through a speech synthesis system, or using pictograms;
- refuse to participate in the study;
- under guardianship, curatorship, or legal 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 |
|---|---|---|
| Tovertafel PixieThe Tovertafel Pixie® projector has a distracting effect, which can help divert the patient's attention while waiting for or undergoing treatment. | Other | Tovertafel Pixie |
Primary outcome
Measurement of anxiety.
Time frame: 1 day
The Kleinknecht Dental Fear Survey (DFS) measures dental anxiety on a scale ranging from 20 (minimum) to 100 (maximum), where higher scores indicate greater levels of fear or anxiety - Comparison of means
1 secondary outcome
Measure the waiting time in the waiting room
Time frame: 1day
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 24 Jun 2026.
- 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.
Isabelle Hyon, M.D principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Odontologic Disorders, run by Nantes University Hospital 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 3 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 24 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?
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?
Contact Isabelle Hyon, M.D (02 44 76 80 78, bp-secretariat-csd@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of anxiety. (time frame: 1 day). 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 24 Jun 2026.