RecruitingNot ApplicableNCT06912854

Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety


Sponsor

University of Southern California

Enrollment

312 participants

Start Date

May 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a randomized clinical trial investigating the effectiveness of a Sensory Adapted Dental Environment (SADE) alone and together with a video-based modeling (VBM) component (VBM-SADE), compared to a regular dental environment (RDE) and/or VBM alone, to reduce anxiety, distress behavior, pain, and sensory discomfort during a dental cleaning in children with and without dental fear and anxiety.


Eligibility

Min Age: 6 YearsMax Age: 12 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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

Interventions

OTHERSensory Adapted Dental Environment

The SADE condition consists of physical adaptations (visual, auditory, tactile modifications) to the dental environment meant to create a less anxiety-provoking sensory experience. Direct overhead fluorescent lighting and the regular dental overhead lamp will be turned off and darkening curtains will cover the windows. Adapted lighting will include slow moving visual color effects (Snoezelen) shining on the ceiling in the child's visual field. The dentist will wear a surgical dental headlamp directed into the patient's mouth, reducing bright lights shining in the child's eyes. Auditory stimuli will be calming rhythmic music (Dan Gibson's Exploring Nature) projected via portable speakers. The tactile deep pressure stimulus will be a commercially available weighted blanket (10-15% of the child's weight) placed on the child to provide deep "hugging" pressure, which produces a calming effect.

OTHERVideo-based Modeling

Participants will watch an approximately 5-minute video depicting a dental cleaning being performed on a sex and age-matched cooperative child, designed to expose the participant to the activities of the dental cleaning and thereby create a less anxiety-provoking dental experience.


Locations(1)

Children's Hospital Los Angeles

Los Angeles, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06912854


Related Trials