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
| Registry | NCT07887243, acronym SMILED |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, supportive care |
| Enrollment | 40 (Estimated) |
| Sponsor | Jagiellonian University (Other) |
| Conditions | Autism, Autism Disorders and Maternal Stress, Sensory Integration Disorder, Stress Biomarkers |
| Interventions | Sensory-Adapted Dental Environment (Behavioral) |
| Dates | start 2026-10-01, primary completion 2026-11-13 (estimated), completion 2026-11-13 (estimated), first posted 2026-10-21, last updated 2026-10-21 |
| Locations | 1 site in Poland |
Related Papers Related Patents Related Grants Related Experts
All trials for Autism All trials for Autism Disorders and Maternal Stress All trials of Sensory-Adapted Dental Environment
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.
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by challenges in social interaction, communication, and restricted, repetitive patterns of behavior. Over 40% of children with ASD report sensory processing difficulties, including hyper-, hypo-reactivity, and mixed responses, particularly to auditory, visual, tactile, and olfactory stimuli. Consequently, routine dental visits, which feature high-intensity sounds, bright overhead lights, distinct odors, and physical touch, often trigger severe anxiety, distress, and uncooperative behaviors in this patient population. This often leads to incomplete procedures or forces dental clinicians to rely on general anesthesia or pharmacological sedation.
A Sensory-Adapted Dental Environment (SADE) modifies sensory aspects of the dental clinic to soothe sensory discomfort, physiological stress, and anxiety. While individual sensory tools show promise, standardized protocols tailored to pediatric ASD patients remain limited, and the bidirectional stress relationship between the child and their accompanying parent during dental visits is insufficiently explored.
This prospective observational study aims to objectively evaluate the effects of a sensory-adapted dental environment on physiological stress markers and behavioral responses in children with ASD and their parents.
Study objectives:
1. To assess dental visit-related stress in children with ASD using objective measurement tools.
2. To evaluate in real time the influence of SADE on the behavior of children with ASD during dental appointments.
3. To assess parental stress and its potential impact on the child with ASD during the dental visit.
Study Design and Procedures: The study will enroll 40 parent-child dyads (40 children aged 8-12 years with a confirmed clinical diagnosis of ASD and IQ > 70, along with one constant parent/guardian). Patients will be recruited from those presenting to the Department of Developmental Age Dentistry, Institute of Dentistry, Jagiellonian University Medical College in Kraków, in accordance with the study's inclusion and exclusion criteria.
Each dyad will complete two standardized afternoon dental procedures spaced 30 days apart to minimize circadian interference and maintain behavioral consistency:
* Visit 1 (Standard Clinical Environment - RDE): Conducted in a standard multi-chair clinical hall without sensory adaptations.
* Visit 2 (Sensory-Adapted Dental Environment - SADE): Conducted in a single-chair operatory modified with specific sensory interventions:
* Visual: Yellow-filtered dental operating lamp and dark protective glasses.
* Auditory: Noise-canceling headphones or relaxing music.
* Tactile: Weighted blanket to provide deep pressure calming effects.
* Olfactory: Sweet orange essential oil diffusion.
* Gustatory: Unflavored prophylaxis toothpaste.
Objective and Subjective Outcome Measures: Both visits will incorporate simultaneous real-time objective and subjective stress assessments for both the child and the parent:
1. Digital Biomarkers of Stress: Continuous physiological monitoring via a certified wrist-worn medical device (Empatica EmbracePlus) recording Heart Rate (HR), Electrodermal Activity (EDA/GSR), Accelerometer data (ACC), Actigraphy, Movement Intensity, Step Count, Metabolic Equivalent of Task (MET), Skin Temperature (ST), and Peripheral Body Orientation.
2. Salivary Stress Biomarkers: Saliva samples will be collected both from children and parents to quantify salivary lysozyme and cortisol levels using ELISA.
3. Behavioral and Psychological Assessments:
* Child self-reported mood evaluated before and after visits using a 3-point pictogram scale (smile, neutral, sad).
* Sensory sensitivity assessed via the Short Sensory Profile 2 (SSP-2) and a custom SMILED Scale (Sensory Monitoring of Individual Level Experiences in Dentistry Scale).
* Parental stress and coping styles measured using the Parental Stress Index (PSI-IV), Coping Inventory for Stressful Situations (CISS), and State-Trait Anxiety Inventory (STAI).
Written informed consent will be obtained from participants at Visit 1, following a detailed explanation of the study objectives, methodology, and their right to withdraw from the project at any stage, as well as after addressing any questions. Participants will be informed about the legal aspects of the project, including GDPR compliance and study insurance.
By objectively measuring real-time autonomic nervous system activation and salivary biomarkers, this study seeks to determine whether SADE implementation can significantly reduce stress and facilitate un-sedated, successful pediatric dental care for children with autism.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| SADE Intervention Group | Experimental | Behavioral: Sensory-Adapted Dental Environment | A prospective, single-arm, non-randomized interventional study where all participating complete two sequential, standardized afternoon dental visits spaced 30 days apart. Visit 1 is conducted under standard clinical conditions (Regular Dental Environment - RDE) on a clinical chair without modifications, serving as the baseline reference. Visit 2 is conducted in a single-chair operatory utilizing a Sensory-Adapted Dental Environment (SADE) featuring multi-sensory adjustments. Both visits involve dental procedures performed by the same pediatric dentist, alongside real-time physiologic stress monitoring (via Empatica EmbracePlus wristbands), salivary sample collection (lysozyme and cortisol assays), pictorial self-report mood assessments, and psychological questionnaires (custom SMILED Scale, SSP-2, PSI-IV, CISS, STAI). |
Sex: All, ages: 8 Years to 12 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Developmental Age Dentistry, Institute of Dentistry, Jagiellonian University Medical College | Krakow, Lesser Poland Voivodeship | Poland |