Recruiting

SADE & VBM

Sponsor:

University of Southern California

Code:

NCT06912854

Conditions

Dental Fear and Anxiety

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Accepted

Interventions

Sensory Adapted Dental Environment

Video-based Modeling

Study Details

Brief 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.

Conditions

Dental Fear and Anxiety

Study ID

NCT06912854

Start date

May 9, 2025

Status verified date

Oct, 2025

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Accepted

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

Study Design

Enrollment

312 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Regular Dental Environment (RDE)

Participants randomized to a RDE will have their dental cleaning administered in a traditional manner (oral examination, prophylaxis, fluoride application) using tell-show-do and basic behavior guidance techniques including positive reinforcement.

experimental: Video-based Modeling (VBM)

Participants randomized to VBM will view a 5-minute video on an iPad that depicts a dental cleaning (oral examination, prophylaxis, and fluoride varnish application) being performed on a sex and age-matched (6-9 yrs v.s 10-12 yrs) cooperative child. This video will feature the model beginning in the waiting room, undertaking a successful cleaning in the absence of any signs of anxiety, choosing a small toy from the dental clinic treasure box, and receiving parental and dentist praise for good behavior.

experimental: Sensory Adapted Dental Environment (SADE)

Participants randomized to the SADE will receive their dental cleaning in a environment in which modifications have been made to visual, auditory, and deep pressure (tactile) stimuli to minimize sensory-related discomforts and maximize relaxation. Visual adaptations include: all direct overhead fluorescent lighting and dental overhead lamp will be turned off; black-out curtains will cover the windows; and application of adapted lighting, which will include slow moving visual color effects (Snoezelen) and the dentist wearing a surgical dental headlamp to direct light into the child's mouth, not eyes. Auditory stimuli will include calming rhythmic music projected via portable speakers. Tactile deep pressure stimuli will be provided via a commercially available weighted blanket placed on the child to provide deep "hugging" pressure, which produces a calming effect.

experimental: Video-based Modeling + Sensory Adapted Dental Environment (VBM-SADE)

Participants randomized to VBM-SADE will view a modeling video prior to their dental cleaning (see Video-based Modeling description) and experience their dental cleaning in a sensory adapted dental environment (see Sensory Adapted Dental Environment description); the pre-cleaning modeling video will portray the same procedural content as in the VBM-only condition, but with the SADE modifications made to the room in which the child actor receives his/her cleaning.

Interventions

Sensory 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.

Video-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.

Primary outcome measure

  • Electrodermal Activity (EDA; Skin Conductance Level [SCL]) [ Time Frame: Periprocedural ]
  • Electrodermal Activity (EDA; Non-specific Skin Conductance Responses [NS-SCR]) [ Time Frame: Periprocedural ]
  • Frequency of Distress Behaviors [ Time Frame: Periprocedural ]
  • Duration of Distress Behaviors [ Time Frame: Periprocedural ]

Central Contacts and Locations

Central contacts

Leah Stein Duker, PhD, OTR/L

323-442-0371lstein@chan.usc.edu

Riley McGuire, OTD, OTR/L, MA

323-442-0672riley.mcguire@chan.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

More Information

Sponsor

University of Southern California

Last update posted

Oct 2, 2025

Last verified

Oct, 2025

Keywords

  • sensory adapted dental environment
  • video-based modeling
  • dental care
  • dental anxiety
  • dental fear

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2025-10-02.