Sensory Adapted Dental Environments to Enhance Oral Care for Children With and Without Dental Fear and Anxiety
Purpose
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.
Condition
- Dental Fear and Anxiety
Eligibility
- Eligible Ages
- Between 6 Years and 12 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- Participants will be randomly assigned to one of four study conditions for their first dental cleaning and then be randomly assigned to one of the three remaining study conditions for their second dental cleaning. We will randomize to treatment order and use counterbalancing, statistically adjust for order of cleaning (i.e., first vs. second cleaning), and covary for any significant interactions between order of cleaning and treatment condition.
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Due to the practicalities of this study and the need to (or not to) modify dental environments and/or provide modeling videos for each participant, blinding of treatment condition for patients or dentists is not applicable. However, for EDA recordings, research team members analyzing/coding data will be masked to condition (SADE, VBM, VBM-SADE, RDE).
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
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. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Southern California