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Dental Fear and AnxietySADE-DFANCT06912854

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

A study testing Sensory Adapted Dental Environment and Video-based Modeling in people with Dental Fear and Anxiety, run by University of Southern California at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Dental Fear and Anxiety
What is being tested?
Sensory Adapted Dental Environment and Video-based Modeling
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
1 siteUnited States
Study dates
9 May 2025to Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

United States1 site, 1 recruiting
  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

    Jose Polido, DDS, MS, 323-361-4116, jpolido@chla.usc.edu

    Jose Polido, DDS, MS

    Recruiting

Other trials in United States

About this study

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.

Being tested
Sensory Adapted Dental Environment, Video-based Modeling
Keywords
sensory adapted dental environment, video-based modeling, dental care, dental anxiety, dental fear
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sensory Adapted Dental EnvironmentOther

    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 ModelingOther

    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.

Study groups in NCT06912854
Study groupRoleWhat they receive
Regular Dental Environment (RDE)No interventionParticipants 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)ExperimentalParticipants 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.
Receives: Other: Video-based Modeling
Sensory Adapted Dental Environment (SADE)ExperimentalParticipants 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.
Receives: Other: Sensory Adapted Dental Environment
Video-based Modeling + Sensory Adapted Dental Environment (VBM-SADE)ExperimentalParticipants 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.
Receives: Other: Sensory Adapted Dental Environment; Other: Video-based Modeling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Periprocedural

  2. 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.

    Measured: Periprocedural

  3. 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).

    Measured: Periprocedural

  4. 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).

    Measured: Periprocedural

Secondary outcomes (14)
  1. Frankl Scale

    The Frankl Scale is a reliable and valid dentist-report measure categorizing the child's (patient's) behavior during the dental encounter into 4 categories/levels of collaboration starting from rating 1 (definitely negative) to rating 4 (definitely positive). Higher scores indicate higher levels of cooperation during dental treatment.

    Measured: Collected immediately after each dental cleaning

  2. Anxiety and Cooperation Scale

    The Anxiety and Cooperation Scale is a reliable and valid dentist-report measure rating the child's (patient's) level of anxiety and cooperation using a 6-point numeric scale. Higher scores indicate higher levels of anxiety and lower levels of cooperation.

    Measured: Collected immediately after each dental cleaning

  3. Wong Baker Faces Pain Scale

    The Wong Baker Faces Pain Scale is a valid tool comprised of six faces to assess perception and intensity of pain. This is a self-report measure with scores ranging from 0-10. Higher scores indicate higher levels of pain.

    Measured: Collected immediately after each dental cleaning

  4. Dental Sensory Sensitivity Scale

    The Dental Sensory Sensitivity Scale is a self-report measure of the presence and magnitude of discomfort with different sensory stimuli in the environment with scores ranging from 0-12. Children rate 6 items on a 0-2 scale of how much the stimuli bothered them (not at all [0]; a little [1]; a lot [2]) after a dental encounter. Higher scores indicate greater sensory discomfort during routine dental treatment.

    Measured: Collected immediately after each dental cleaning

  5. Subjective Thoroughness of Cleaning Scale

    The Subjective Thoroughness of Cleaning Scale describes the efficacy of the dental encounter, as perceived by the dentist, and documents the presence/absence of behavioral issues and whether or not they impeded care. Scores range from 0-13 with higher scores indicating a more thorough cleaning.

    Measured: Collected immediately after each dental cleaning

  6. Client Satisfaction Questionnaire

    The Client Satisfaction Questionnaire is a reliable and valid self-report measure used to assess client/patient perception of satisfaction with services and clinical care. Items are rated on a 4-point Likert scale with varying response options (e.g., 1 = "poor" to 4 = "fair"; 1 = "quite dissatisfied" to 4 = "very satisfied"). Scores range from 8-32 with higher scores indicating greater satisfaction.

    Measured: Collected immediately after each dental cleaning

  7. Child Intervention Experience Form

    The Child Intervention Experience Form is a self-report measure of how much the child liked the intervention-related adaptations to their dental encounter. Scores range from 1-45 with higher scores indicating a more positive experience.

    Measured: Collected immediately after each dental cleaning

  8. Caregiver Intervention Experience Form

    The Caregiver Intervention Experience Form is a self-report a measure of how much the caregiver liked the intervention-related adaptations to the dental encounter for their child. Scores range from 1-75 with higher scores indicating a more positive experience.

    Measured: Collected immediately after each dental cleaning

  9. Dentist Intervention Experience Form

    The Dentist Intervention Experience Form is a measure of how much the dentist liked the intervention-related adaptations to the dental encounter, both for their patient and themselves. Scores range from 10-51 with higher scores indicating a more positive experience.

    Measured: Collected immediately after each dental cleaning

  10. State-Trait Anxiety Inventory - Short Form

    The State Trait Anxiety Inventory Short Form is a commonly used reliable and valid self-report measure to assess an individual's state and trait anxiety. Items are scored on a 4-point Likert scale with scores ranging from 20 - 80. Higher scores indicate higher levels of state and trait anxiety.

    Measured: Collected immediately after each dental cleaning

  11. Stress Appraisal Measure

    The Stress Appraisal Measure is a comprehensive tool to measure an individual's appraisal of stress. Items are scored on a 5-point Likert scale with scores ranging from 28 - 140. Higher scores indicate higher stress.

    Measured: Collected immediately after each dental cleaning

  12. Semi-Structured Interview of Dentists

    The Semi-structured Exit Interview of Dentists is a tool to obtain qualitative information about their participation and perception of the study interventions.

    Measured: Through study completion, an average of 1 year

  13. Children's Fear Survey Schedule - Dental Subscale

    The Children's Fear Survey Schedule-Dental Subscale is a reliable and valid self- or caregiver-report measure to assess dental fear and anxiety in children. Items are scored on a 5-point Likert scale with scores ranging from 12-75. Higher scores indicate greater dental fear and anxiety. A score of less than 32 indicates non-clinical range, scores between 32-38 indicate borderline range, and scores greater than or equal to 39 indicial clinical range of dental fear and anxiety.

    Measured: Collected prior to participant's first dental cleaning

  14. Short Sensory Profile

    The Short Sensory Profile is a reliable and valid caregiver-report measure to collect information about how children respond to sensory input in daily life activities. Scores at or above 1 standard deviation below the mean indicate typical sensory symptoms. Score at or above the point 2 SD below the mean, but lower than 1 SD below the mean indicate a possible difference in sensory symptoms. Scores below the point 2 SD below the mean indicate a definite difference in sensory symptoms.

    Measured: Collected prior to participant's first dental cleaning

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2025
  2. Study start9 May 2025
  3. Primary completionMar 2029 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
312 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06912854
Sponsor's protocol ID
CHLA-24-00096
Other IDs
UH3DE031222
Acronym
SADE-DFA
Status last verified
Oct 2025
First submitted
18 Mar 2025
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sensory Adapted Dental Environment and Video-based Modeling in people with Dental Fear and Anxiety, run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Leah Stein Duker, PhD, OTR/L (323-442-0371, lstein@chan.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Electrodermal Activity (EDA; Skin Conductance Level [SCL]) (time frame: Periprocedural). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

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