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NCT07887243

Adapting the Sensory Environment to Reduce Stress in Children With Autism During Dental Visits

Sponsor: Jagiellonian University

View on ClinicalTrials.gov

Summary

This study aims to evaluate the impact of a sensory-adapted dental environment (SADE) on the stress levels and behavioral responses of children with autism spectrum disorder (ASD) during dental visits. Children with ASD often experience sensory sensitivities, making traditional dental care challenging and stressful. In this study, 40 children aged 8 to 12 diagnosed with ASD, along with their parents or legal guardians, will participate in two standard dental visits spaced 30 days apart. The first visit will take place under standard clinical conditions, while the second visit will utilize a sensory-adapted dental environment featuring modified visual elements (such as dark protective glasses), auditory (noise-canceling headphones or relaxing music), taste (unflavored toothpaste), smell (sweet orange essential oil) and tactile adjustments (a weighted blanket). The study will measure stress using objective tools, including continuous digital biomarkers of stress recorded via wristbands (such as heart rate, electrodermal activity, accelerometer data, actigraphy, movement intensity, step count, metabolic equivalent of task, skin temperature, and peripheral body orientation) and the analysis of salivary lysozyme and cortisol levels in both children and parents. Additionally, standardized psychological questionnaires will be used to assess the child's sensory profile, as well as parental stress and coping strategies. The findings will help determine whether modifying the sensory environment can effectively reduce anxiety and improve the dental care experience for children with autism.

Official title: Assessment of Dental-related Physiological Stress and Sensory Profiles in Children With Autism Spectrum Disorder Undergoing Routine Dental Care in Regular and Sensory-adapted Environments, and Associated Parental Stress: a Prospective Single-arm Interventional Study

Key Details

Gender

All

Age Range

8 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-01

Completion Date

2026-11-13

Last Updated

2026-10-21

Healthy Volunteers

Conditions

Autism Autism Disorders and Maternal Stress Sensory Integration Disorder Stress Biomarkers

Interventions

BEHAVIORAL

Sensory-Adapted Dental Environment

A multi-sensory adaptation of the dental operatory applied during the second study visit (Visit 2). The modification includes five components: visual (yellow-filtered operating lamp and dark protective glasses), auditory (noise-canceling headphones or relaxing music), tactile (a weighted blanket), olfactory (sweet orange essential oil diffusion), and gustatory (unflavored prophylaxis toothpaste). The first visit serves as the control condition using a Regular Dental Environment (RDE) without these modifications.

Inclusion Criteria: 1. Child Inclusion Criteria * Age: 8-12 years. * Diagnosis of Autism Spectrum Disorder (ASD): Official ASD diagnosis according to ICD-10, ICD-11, or DSM-5 criteria, confirmed by medical documentation from a psychiatrist/pediatric psychiatrist, a psychologist's opinion, or a diagnostic team. * No Prior Contact: No prior contact with the proposed intervention (e.g., the specific calming techniques used in the study). * Absence of Profound Cognitive Deficits: Required level of intellectual functioning: IQ \> 70. * Stable Mental and Somatic Health Status: Over the last 30 days, with no sudden health exacerbations (e.g., psychiatric episodes, hospitalizations). * Consent to Participate: Written informed consent obtained from the parent/legal guardian, along with the child's assent appropriate to their developmental level. 2. Parent/Legal Guardian Inclusion Criteria * Role and Age: Parent or legal guardian of the minor participant diagnosed with ASD, aged over 18 years. * Consent to Participate: Written informed consent obtained from the parent/legal guardian as a study participant. * Health Status: Stable mental and somatic health status over the last 30 days. Exclusion Criteria: 1. Child Exclusion Criteria * Current Anxiety Treatment: Child undergoing psychological or pharmacological therapy directly aimed at treating anxiety (e.g., CBT, anti-anxiety medications). * Changes in Psychotropic Medication: Initiation of a new psychotropic drug or dosage change within the 4 weeks prior to the study. * Diagnosis of Other Mental Disorders: Schizophrenia, schizoaffective disorders, or bipolar affective disorders that could interfere with the study. * Clinically Significant Suicidal Ideation: Present currently or in the recent history. * Persistent Aggression or Self-Aggression: Behaviors that may prevent the safe execution of the dental procedure. * Somatic Comorbidities Co-occurring with ASD: Conditions that may increase stress-related risks, such as pharmacologically uncontrolled epilepsy, heart failure, unstable type 1 diabetes, or central nervous system disorders. * Significant Family Life Instability: Within the last 4 weeks (e.g., relocation, divorce, crisis interventions). * Oral Pain or Salivary Disorders: Dental pain originating from the oral cavity or salivary gland secretion disorders in the child. * Lack of Consent: Absence of written consent from the parent/legal guardian or lack of the child's assent to participate. * Upper Respiratory Tract Infection: Occurring within the last 7 days. 2. Parent/Legal Guardian Exclusion Criteria * Lack of Consent: Absence of written consent from the parent/legal guardian to participate as a study subject. * Oral Pain or Salivary Disorders: Dental pain originating from the oral cavity or salivary gland secretion disorders in the parent/legal guardian. * Severe Mental Function Disorders: Diagnosed severe mental impairment requiring therapy with high doses of neurotropic drugs. * Significant Family Life Instability: Within the last 4 weeks (e.g., relocation, divorce, crisis interventions). * Upper Respiratory Tract Infection: Occurring within the last 7 days. Because the study is conducted in parent-child dyads, the refusal or withdrawal of consent by one participant automatically excludes the other from the study.

Locations (1)

Department of Developmental Age Dentistry, Institute of Dentistry, Jagiellonian University Medical College

Krakow, Lesser Poland Voivodeship, Poland