- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06776653
Impact of a Snoezelen Element on Anxiety in Patients During Oral Care: A Real-Life Study at Nantes University Hospital (IISLA)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Isabelle Hyon, M.D
- Phone Number: 02 44 76 80 78
- Email: bp-secretariat-csd@chu-nantes.fr
Study Contact Backup
- Name: Alexandra Poinas, PhD
- Phone Number: 02 53 48 28 57
- Email: alexandra.poinas@chu-nantes.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Tovertafel Pixie
Patients who will have the Tovertafel Pixie in the waiting room and the consultation room
|
The Tovertafel Pixie® projector has a distracting effect, which can help divert the patient's attention while waiting for or undergoing treatment.
|
|
controle
Patients without the Tovertafel Pixie in the waiting room and the consultation room
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure the waiting time in the waiting room
Time Frame: 1day
|
Measure the waiting time in the waiting room in minutes
|
1day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Isabelle Hyon, M.D, Nantes University Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AP_IH_IISLA_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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