Sensory-adapted dental care with optional video modeling for children with dental fear
Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety
NA · University of Southern California · NCT06912854
This test will see if changing the sights and sounds in the dental room, with or without a short video model, helps reduce anxiety, pain, and discomfort during cleanings for children aged 6–12 with or without dental fear.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | University of Southern California (other) |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06912854 on ClinicalTrials.gov |
What this trial studies
This randomized trial compares a Sensory Adapted Dental Environment (SADE) alone and combined with video-based modeling (VBM-SADE) to a regular dental environment (RDE) and VBM alone during routine dental cleanings. Eligible children aged 6–12 who speak English or Spanish and have had at least one prior cleaning are randomized to one of the intervention arms before a cleaning appointment. Outcomes include observed distress behaviors, self-reported pain and sensory discomfort, and physiological measures of arousal during the procedure. The study is run at Children's Hospital Los Angeles in collaboration with the University of Southern California and the NIDCR.
Who should consider this trial
Good fit: Children aged 6–12 who speak English or Spanish, have had at least one prior dental cleaning, and do not have major developmental disabilities, recent cleanings, braces, or medical conditions that raise safety concerns.
Not a fit: Children with intellectual or developmental disabilities (such as autism), significant medical conditions, orthodontic braces, or those who had a dental cleaning within the past 4 months are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could make routine dental cleanings less frightening and more comfortable for many children, improving cooperation and oral health care.
How similar studies have performed: Prior smaller studies and behavioral research suggest sensory adaptations and video modeling can reduce pediatric distress in dental and medical settings, but robust randomized evidence in general pediatric populations is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female, aged 6 through 12 years, of any race/ethnicity; * English- or Spanish-speaking child and parent; * Have experienced at least one prior dental cleaning; * If recruited from the emergency department, Emergency Severity Index (ESI) must be level V or IV (to ensure that greater severity PED patients not be recruited). Exclusion Criteria: * Dental cleaning within the previous 4 months (i.e., not in need of cleaning); * Plan to move out of the area within 6 months; * Intellectual or developmental disability (e.g. autism; highly co-morbid with sensory processing difficulties); * Disability that would interfere with oral care (e.g. cleft lip/palate, cerebral palsy, genetic/endocrine/metabolic dysfunction) or medical condition that would place the child at increased risk during the study (e.g., uncontrollable seizures); * Daily use of anti-cholinergic drugs (i.e., interferes with EDA recordings); * Presence of orthodontia (braces) or with a plan to get braces in the upcoming 6 months
Where this trial is running
Los Angeles, California
- Children's Hospital Los Angeles — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: Leah Stein Duker, PhD, OTR/L — University of Southern California
- Study coordinator: Leah Stein Duker, PhD, OTR/L
- Email: lstein@chan.usc.edu
- Phone: 323-442-0371
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dental Fear and Anxiety, sensory adapted dental environment, video-based modeling, dental care, dental anxiety, dental fear