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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
312
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.
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.
Children's Hospital Los Angeles
Los Angeles, California, United States
RECRUITINGElectrodermal 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Periprocedural
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.
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Time frame: Collected immediately after each dental cleaning
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.
Time frame: Collected immediately after each dental cleaning
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.
Time frame: Collected immediately after each dental cleaning
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.
Time frame: Collected immediately after each dental cleaning
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.
Time frame: Collected immediately after each dental cleaning
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.
Time frame: Collected immediately after each dental cleaning
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.
Time frame: Collected immediately after each dental cleaning
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.
Time frame: Collected immediately after each dental cleaning
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.
Time frame: Collected immediately after each dental cleaning
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.
Time frame: Collected immediately after each dental cleaning
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.
Time frame: Collected immediately after each dental cleaning
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.
Time frame: Through study completion, an average of 1 year
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.
Time frame: Collected prior to participant's first dental cleaning
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.
Time frame: Collected prior to participant's first dental cleaning