Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- University of Southern California
- Study ID
- NCT06912854
- Status
- Recruiting
Conditions
- Dental Fear and Anxiety
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - 12 Years
- Healthy Volunteers
- Accepted
Interventions
- Sensory Adapted Dental Environment — OTHERThe 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 — OTHERParticipants 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.
Study Details
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.
Key Dates
- Start date
- May 9, 2025
- Status verified
- Oct 2025
- Primary completion
- Mar 31, 2029
- Completion
- Mar 31, 2029
Study Design
- Enrollment
- 312 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- OTHER
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.
Primary Outcome Measure
Electrodermal Activity (EDA; Skin Conductance Level [SCL]) [ Time Frame: Periprocedural ]
Central Contacts
- Leah Stein Duker, PhD, OTR/L323-442-0371
- Riley McGuire, OTD, OTR/L, MA323-442-0672
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | Jose Polido, DDS, MS (SUB_INVESTIGATOR) |
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