Sensory Processing Disorder
Conditions
Keywords
sensory processing disorders, pediatric dentistry, dental anxiety, behavioral outcomes, sensory adaptation, crossover randomized controlled trial, sensory modulation disorder, sensory over-responsivity
Brief summary
This clinical trial examines the efficacy of a Sensory-Adapted Dental Environment (SADE) in reducing anxiety and improving behavioral outcomes in children with sensory processing disorders during routine dental visits. By modifying the dental setting to accommodate sensory sensitivities-such as using dim lighting, noise-canceling headphones, and non-threatening dental tools-the study aims to create a more comfortable dental experience for these children. This research could potentially inform broader pediatric dentistry practices, making dental care more accessible and less distressing for children with sensory sensitivities.
Detailed description
The study is a crossover randomized controlled trial designed to assess the impact of a Sensory-Adapted Dental Environment (SADE) on children with sensory processing disorders, focusing on both physiological and behavioral responses. Participants will undergo two dental cleaning visits; one in a standard dental environment and one in a sensory-adapted setting. Each visit will be spaced three to four months apart to monitor short-term effects and behaviors. The primary outcomes measured will include changes in anxiety levels, as assessed by physiological markers (e.g., heart rate) and behavioral scales (e.g., modified dental anxiety scale). Secondary outcomes will evaluate the overall acceptance of the sensory-adapted environment by children and their caregivers. This study seeks to demonstrate that tailored environmental modifications can significantly improve the dental care experience, potentially leading to enhanced long-term dental health and reduced care avoidance among children with sensory processing disorders. The trial will also gather qualitative feedback from participants and their parents to better understand individual experiences and refine future adaptations in pediatric dental practices.
Interventions
BEHAVIORALSensory-Adapted Dental Environment
The Sensory-Adapted Dental Environment (SADE) involves altering the dental setting to reduce sensory stimuli that can cause discomfort or anxiety in children with sensory processing disorders. This includes the use of controlled lighting, ambient sounds, and non-threatening tools to create a calming atmosphere conducive to positive dental experiences.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All participants and study personnel involved in the delivery and assessment of the treatment outcomes are blinded to the phase order to maintain the integrity of the study results.
Intervention model description
Participants will receive dental care in both a standard and a sensory-adapted dental environment in a randomized order to compare effects on anxiety and behavior.
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document. * For children, informed assent and parental informed consent to participate in the study. * Males and females; Age \<5-17 years\> * Self-reported or documented diagnosis of sensory processing disorder (SPD), sensory modulation disorder (SMD), or sensory over-responsivity (SOR) based on medical records or occupational therapy evaluation. Diagnosis codes per ICD-10 may include, but are not limited to, F88 and F89 for SPD, as these are often used for atypical neurodevelopmental conditions where specific sensory challenges are present. * A score above the threshold on the Sensory Profile-2, which indicates significant sensory processing issues. * A history of at least one previous dental cleaning, to ensure familiarity with the dental care process. * Willingness and ability to adhere to the study intervention regimen, including attending two dental sessions in different environmental settings (RDE and SADE). * Ability to attend intervention sessions at the designated site, UT Health School of Dentistry. * Access to transportation or necessary resources for participating in the study sessions at the UT Health School of Dentistry. * Not currently undergoing orthodontic braces treatment or using anticholinergic medication, as per the
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of SADE on Heart Rate | Baseline to approximately 50 minutes (after dental appointment) | This measure evaluates the impact of the Sensory-Adapted Dental Environment (SADE) on physiological indicators of anxiety, specifically heart rate change. |
| Effect of SADE on Oxygen Saturation | Baseline to approximately 50 minutes (after dental appointment) | This measure evaluates the impact of the Sensory-Adapted Dental Environment (SADE) on physiological indicators of anxiety, specifically oxygen saturation change. |
| Effect of SADE on Systolic and Diastolic Blood Pressure | Baseline to approximately 50 minutes (after dental appointment) | This measure evaluates the impact of the Sensory-Adapted Dental Environment (SADE) on physiological indicators of anxiety, with change in systolic or diastolic blood pressure. |
| Frankl Behavior Rating Scale Change | Baseline to approximately 50 minutes (after dental appointment) | A change in score on the Frankl behavioral rating scale. This is a scored as a single rating of behavior between 1 and 4 with a higher score indicating a more positive attitude. |
| Ohio State University Behavior Rating Scale | Baseline to approximately 50 minutes (after dental appointment) | This scale rates the participants' behavior. A change in score on the behavioral rating scale. This is a scored as a single rating of behavior between 1 and 4 with a lower score indicating a more positive attitude. |
| Venham's Clinical Anxiety Scale | Baseline to approximately 50 minutes (after dental appointment) | A scale used to measure the change in clinical anxiety of participants will be a single item scored from 0-3, where a higher score indicates more anxiety and protest from the participant. |
| Wong Bakers Visual FACES Scale Modified | Visit 1 Day 1 to Visit 2 (May occur Day 90-120) | A modification of Wong-Baker scale designed to understand the child's anxiety on the same scale and faces pattern, pre-visit and post-visit. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNida-e-Haque Mahmud, DDS, BDS
The University of Texas Health Science Center at San Antonio
Outcome results
None listed