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

NCT06912854 | Recruiting

• 2 other identifiers: CHLA-24-00096UH3DE031222
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Electrodermal Activity (EDA; Skin Conductance Level [SCL])

  Electrodermal Activity (EDA; skin conductance level \[SCL\]) reflects the activation of the sympathetic 'fight or flight' nervous system and is well-documented to increase in stressful or painful situations. A BIOPAC MP160 System will be used to record the child's EDA. The child will relax in dental chair for three minutes in order to obtain a resting baseline EDA measurement, followed by EDA recording for the duration of the dental cleaning.

  Periprocedural

• Electrodermal Activity (EDA; Non-specific Skin Conductance Responses [NS-SCR])

  Electrodermal Activity (EDA; frequency of non-specific skin conductance responses \[NS-SCR\]) reflects the activation of the sympathetic 'fight or flight' nervous system and is well-documented to increase in stressful or painful situations. A BIOPAC MP160 System will be used to record the child's EDA. The child will relax in dental chair for three minutes in order to obtain a resting baseline EDA measurement, followed by EDA recording for the duration of the dental cleaning.

  Periprocedural

• Frequency of Distress Behaviors

  Frequency of distress behaviors will be scored from video-recordings of the dental cleanings. A trained research team member will assess the count of mouth movements, head movements, and verbal distress behaviors (whimper/cry/scream).

  Periprocedural

• Duration of Distress Behaviors

  Duration of distress behaviors will be scored from video-recordings of the dental cleanings. A trained research team member will assess the duration of verbal distress behaviors (whimper/cry/scream).

  Periprocedural

Secondary Outcomes (14)

• Frankl Scale

  Collected immediately after each dental cleaning

• Anxiety and Cooperation Scale

  Collected immediately after each dental cleaning

• Wong Baker Faces Pain Scale

  Collected immediately after each dental cleaning

• Dental Sensory Sensitivity Scale

  Collected immediately after each dental cleaning

• Subjective Thoroughness of Cleaning Scale

  Collected immediately after each dental cleaning

Other Outcomes (2)

• Cleaning Duration

  Periprocedural

• Added Procedural Costs

  Periprocedural

Study Arms (4)

Regular Dental Environment (RDE)

NO INTERVENTION

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.

Video-based Modeling (VBM)

EXPERIMENTAL

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.

Other: Video-based Modeling

Sensory Adapted Dental Environment (SADE)

EXPERIMENTAL

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.

Other: Sensory Adapted Dental Environment

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

EXPERIMENTAL

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.

Other: Sensory Adapted Dental Environment; Other: Video-based Modeling

Interventions

Sensory Adapted Dental Environment OTHER

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.

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

Video-based Modeling OTHER

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.

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

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• Children's Hospital Los Angeles: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Leah Stein Duker, PhD, OTR/L

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Stein Duker, PhD, OTR/L

CONTACT

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

Riley McGuire, OTD, OTR/L, MA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 6, 2025
• Study Start: May 9, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)