- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07719205
Tactile Pre-Visit Imagery
Tactile Pre-Visit Imagery Effect on Behavior of Children During Dental Procedures
In pediatric dentistry, our primary goals are to prevent dental caries and, when necessary, provide treatment in a safe and comforting environment that minimizes anxiety for young patients. By familiarizing young patients with the steps involved in common dental procedures, tactile pre-visit imagery booklets can reduce the fear of the unknown.
Study Objective/Purpose: The purpose of this study is to determine whether tactile pre-visit imagery could reduce dental anxiety and fear in pediatric patients prior to their first restorative procedure. An additional aspect of this study entails assessing the patient's behavior and determining if it improves with the use of a tactile pre-visit imagery booklet.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90089
- Recruiting
- USC Herman Ostrow School of Dentistry - Pediatric Dental Clinic
-
Contact:
- Catherine Pham
- Phone Number: 213-740-0412
- Email: cmpham@usc.edu
-
Santa Ana, California, United States, 92704
- Recruiting
- Altamed Dental Clinic
-
Contact:
- Alyssa Nowlen
- Phone Number: 888-499-9303
- Email: annowlen@usc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 4-10 years
- ASA I or II
- Patients who have NOT had dental treatment before
- Patients needing at least ONE composite filling or stainless steel crown [CP1] with nitrous oxide and local anesthesia (composite filling must be done at the first treatment visit)
- Parents and children must speak English or Spanish
Exclusion Criteria:
- Children with developmental delays or cognitive impairments that may impact their ability to participate in pre-visit imagery activities
- Patients with visual or tactile disabilities associated for a particular medical condition or as reported on their medical history form
- Patients who refuse to wear nitrous hood
- Emergency dental appointments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tactile Previsit Imagery
Receives tactile previsit imagery booklet
|
Physical Booklet that walks patient through all materials used during the dental treatmne and contains physical items that are going to be used so that patient can touch and feel.
|
|
No Intervention: No Tactile Previsit Imagery
No additional previsit imagery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dental Anxiety
Time Frame: At baseline (pre-intervention) and immediately after treatment (post-intervention)
|
Change in dental anxiety before and after treatment.
The Venham Picture test is used to measure the child's anxiety.
The scores from the Venham Picture test will be compared between pre- and post- treatment to determine changes in dental anxiety.
|
At baseline (pre-intervention) and immediately after treatment (post-intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Behavior
Time Frame: At baseline (preintervention) and immediately after treatment (post-intervention)
|
Change in behavior/cooperation of patient before and after treatment.
Child's behavior will be measured using the Frankl Behavior score.
The Frankl score will be recorded pre- and post-treatment to determine a change in behavior.
|
At baseline (preintervention) and immediately after treatment (post-intervention)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
- HS-25-00212
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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