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

Not Applicable

Not yet recruiting

• Conditions: Dental Fear and Anxiety

• Registration Number: NCT06912854
• Lead Sponsor: University of Southern California

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-28
• Last Update Submitted: 2025-03-28
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Study Start: 2025-05
• Primary Completion: 2029-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 312

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Caregiver Intervention Experience Form	Collected immediately after each dental cleaning	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.
Dentist Intervention Experience Form	Collected immediately after each dental cleaning	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.
Child Intervention Experience Form	Collected immediately after each dental cleaning	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.
Frankl Scale	Collected immediately after each dental cleaning	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.
Anxiety and Cooperation Scale	Collected immediately after each dental cleaning	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.
Wong Baker Faces Pain Scale	Collected immediately after each dental cleaning	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.
Dental Sensory Sensitivity Scale	Collected immediately after each dental cleaning	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.
Subjective Thoroughness of Cleaning Scale	Collected immediately after each dental cleaning	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.
Client Satisfaction Questionnaire	Collected immediately after each dental cleaning	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.
State-Trait Anxiety Inventory - Short Form	Collected immediately after each dental cleaning	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.
Stress Appraisal Measure	Collected immediately after each dental cleaning	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.
Semi-Structured Interview of Dentists	Through study completion, an average of 1 year	The Semi-structured Exit Interview of Dentists is a tool to obtain qualitative information about their participation and perception of the study interventions.
Children's Fear Survey Schedule - Dental Subscale	Collected prior to participant's first dental cleaning	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.
Short Sensory Profile	Collected prior to participant's first dental cleaning	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.

Trial Locations

Locations (1)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States