NCT06776653

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

1 month

First QC Date

December 20, 2024

Last Update Submit

January 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    1 day

Secondary Outcomes (1)

  • Measure the waiting time in the waiting room

    1day

Study Arms (2)

Tovertafel Pixie

Patients who will have the Tovertafel Pixie in the waiting room and the consultation room

Other: Tovertafel Pixie

controle

Patients without the Tovertafel Pixie in the waiting room and the consultation room

Interventions

The Tovertafel Pixie® projector has a distracting effect, which can help divert the patient's attention while waiting for or undergoing treatment.

Tovertafel Pixie

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

  • Isabelle Hyon, M.D

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2024

First Posted

January 15, 2025

Study Start

January 15, 2025

Primary Completion

February 15, 2025

Study Completion

March 15, 2025

Last Updated

January 15, 2025

Record last verified: 2025-01