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AutismSMILEDNCT07887243

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

A study testing Sensory-Adapted Dental Environment in people with Autism and Autism Disorders and Maternal Stress, run by Jagiellonian University at 1 site in Poland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 8 to 12 years
What is being tested?
Sensory-Adapted Dental Environment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePoland
Study dates
1 Oct 2026to 13 Nov 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).
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  • Consent to Participate: Written informed consent obtained from the parent/legal guardian, along with the child's assent appropriate to their developmental level.
  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

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

    Krakow, Lesser Poland Voivodeship, 31-155

Other trials in Poland

About this study

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

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.

Read the detailed description

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.

Being tested
Sensory-Adapted Dental Environment
Keywords
Autism Spectrum Disorder (ASD), Sensory-Adapted Dental Environment (SADE), Pediatric Dentistry, Digital Biomarkers of Stress, Salivary Lysozyme, Salivary Cortisol, Parental Stress, Sensory Processing, EmbracePlus, Empatica, Wearable sensors, SMILED
Medical subject headings
Autistic Disorder, Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sensory-Adapted Dental EnvironmentBehavioural

    Also called SADE, Multi-sensory dental adaptation

    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.

Study groups in NCT07887243
Study groupRoleWhat they receive
SADE Intervention GroupExperimentalA 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).
Receives: Behavioral: Sensory-Adapted Dental Environment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Child Electrodermal Activity (EDA) via Wearable Device (Empatica EmbracePlus)

    Continuous recording of skin conductance (in microSiemens, μS) via Empatica EmbracePlus to to measure child physiological stress during dental visits in RDE versus SADE conditions.

    Measured: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.

  2. Change in Child Heart Rate (HR) via Wearable Device (Empatica EmbracePlus)

    Continuous recording of heart rate (in beats per minute, bpm) via Empatica EmbracePlus to measure child physiological stress during dental visits in RDE versus SADE conditions.

    Measured: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.

  3. Change in Child Respiration Rate (RR) via Wearable Device (Empatica EmbracePlus)

    Continuous recording of respiratory rate (in breaths per minute, rpm) via Empatica EmbracePlus to assess child physiological stress during dental visits in RDE versus SADE conditions.

    Measured: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.

  4. Change in Child Skin Temperature (ST) via Wearable Device (Empatica EmbracePlus)

    Continuous recording of skin temperature (in degrees Celsius, °C) via Empatica EmbracePlus to measure child physiological stress during dental visits in RDE versus SADE conditions.

    Measured: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.

  5. Change in Child Actigraphy-Derived Physical Activity Metrics via Wearable Device (Empatica EmbracePlus)

    Continuous recording of actigraphy data derived from the tri-axial accelerometer (in gravitational force units, g) to assess child physical restlessness during dental visits in RDE versus SADE conditions.

    Measured: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.

  6. Change in Child Metabolic Equivalent of Task (MET) via Wearable Device (Empatica EmbracePlus)

    Estimation of child energy expenditure measured in MET values via Empatica EmbracePlus during dental visits in RDE versus SADE conditions.

    Measured: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.

  7. Change in Child Salivary Lysozyme Levels

    Quantification of salivary lysozyme concentration (in µg/mL) assessed via ELISA from saliva samples collected using the spit method immediately post-visit to measure child stress changes between RDE and SADE visits.

    Measured: Saliva samples collected immediately post-visit at Visit 1 (Day 1) and Visit 2 (approx. Day 30), covering a total study period of approx. 30 days; samples subsequently analyzed in the laboratory.

  8. Change in Child Salivary Cortisol Levels

    Quantification of salivary cortisol concentration (in nmol/L) assessed via ELISA from saliva samples collected using the spit method immediately post-visit to measure child stress changes between RDE and SADE visits.

    Measured: Saliva samples collected immediately post-visit at Visit 1 (Day 1) and Visit 2 (approx. Day 30), covering a total study period of approx. 30 days; samples subsequently analyzed in the laboratory.

Secondary outcomes (14)

  1. Sensory Monitoring of Individual Level Experiences in Dentistry (SMILED Scale)

    Assessment of child sensory reactivity and adaptation efficiency during dental visits using the custom SMILED scale based on clinical observation. Part 1 assesses baseline sensory reactivity across 7 modalities (visual, auditory, tactile, proprioceptive/vestibular, gustatory, olfactory, environmental), with each scored from 1 (severe difficulties) to 5 (stable regulation) for a total baseline score range of 7 to 35. Part 2 assesses the efficacy of 8 specific sensory adaptations scored from 1 (ineffective) to 5 (stable tolerance), yielding an Adaptation Efficacy Index (difference between mean adaptation score and mean baseline score, where positive values indicate improved sensory regulation).

    Measured: Assessed at Visit 1 (Day 1) and Visit 2 (approx. Day 30), covering a total study duration of approximately 30 days.

  2. Child Sensory Profile (SSP-2)

    Assessment of the child's sensory processing profile using the Polish version of the Short Sensory Profile 2 (SSP-2) completed by parents. The questionnaire consists of 34 items rated on a 5-point Likert scale, yielding a total score ranging from 34 to 170. Higher scores reflect typical sensory processing performance, while lower scores indicate greater sensory difficulties across quadrants (Seeking, Avoiding, Sensitivity, Registration).

    Measured: Assessed at baseline during Visit 1 (Day 1).

  3. Child Emotional State

    Assessment of the child's emotional state using a 3-point pictogram scale (3 = smiling/happy face, 2 = neutral face, 1 = sad/upset face). Higher scores represent a better emotional state.

    Measured: Assessed immediately before and immediately after each dental visit at Visit 1 (Day 1) and Visit 2 (approx. Day 30), covering a total study period of approximately 30 days.

  4. Change in Parental Electrodermal Activity (EDA) via Wearable Device (Empatica EmbracePlus)

    Continuous recording of skin conductance (in microSiemens, μS) via Empatica EmbracePlus to to measure parental physiological stress during dental visits in RDE versus SADE conditions.

    Measured: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.

  5. Change in Paretal Heart Rate (HR) via Wearable Device (Empatica EmbracePlus)

    Continuous recording of heart rate (in beats per minute, bpm) via Empatica EmbracePlus to measure parental physiological stress during dental visits in RDE versus SADE conditions.

    Measured: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.

  6. Change in Parental Respiration Rate (RR) via Wearable Device (Empatica EmbracePlus)

    Continuous recording of respiratory rate (in breaths per minute, rpm) via Empatica EmbracePlus to assess parental physiological stress during dental visits in RDE versus SADE conditions.

    Measured: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.

  7. Change in Parental Skin Temperature via Wearable Device (Empatica EmbracePlus)

    Continuous recording of skin temperature (in degrees Celsius, °C) via Empatica EmbracePlus to measure parental physiological stress during dental visits in RDE versus SADE conditions.

    Measured: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.

  8. Change in Parental Actigraphy-Derived Physical Activity Metrics via Wearable Device (Empatica EmbracePlus)

    Continuous recording of actigraphy data derived from the tri-axial accelerometer (in gravitational force units, g) to assess parental physical restlessness during dental visits in RDE versus SADE conditions.

    Measured: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.

  9. Change in Parental Metabolic Equivalent of Task (MET) via Wearable Device (Empatica EmbracePlus)

    Estimation of parental energy expenditure measured in MET values via Empatica EmbracePlus during dental visits in RDE versus SADE conditions.

    Measured: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.

  10. Change in Parental Salivary Lysozyme Levels

    Quantification of salivary lysozyme concentration (in µg/mL) assessed via ELISA from saliva samples collected using the spit method immediately post-visit to measure parental stress changes between RDE and SADE visits.

    Measured: Saliva samples collected immediately post-visit at Visit 1 (Day 1) and Visit 2 (approx. Day 30), covering a total study period of approx. 30 days; samples subsequently analyzed in the laboratory.

  11. Change in Parental Salivary Cortisol Levels

    Quantification of salivary cortisol concentration (in nmol/L) assessed via ELISA from saliva samples collected using the spit method immediately post-visit to measure cparental stress changes between RDE and SADE visits.

    Measured: Saliva samples collected immediately post-visit at Visit 1 (Day 1) and Visit 2 (approx. Day 30), covering a total study period of approx. 30 days; samples subsequently analyzed in the laboratory.

  12. Parental Stress Level (PSI-4 or SIPA)

    Assessment of parenting and child-related stress measured by the Parenting Stress Index, Fourth Edition (PSI-4) or Stress Index for Parents of Adolescents (SIPA), depending on the child's age. Total stress percentile/score ranges from low to high parental stress, with higher scores indicating higher stress.

    Measured: Assessed at baseline during Visit 1 (Day 1).

  13. Parental Coping Strategies (CISS)

    Assessment of preferred coping styles using the Coping Inventory for Stressful Situations (CISS), evaluating task-oriented, emotion-oriented, and avoidance-oriented coping dimensions. Scores on each subscale range from 16 to 80, with higher scores indicating higher reliance on that coping strategy.

    Measured: Assessed at baseline during Visit 1 (Day 1).

  14. Change in Parental Anxiety Levels (STAI)

    Assessment of parental anxiety using the State-Trait Anxiety Inventory (STAI), comprising two subscales: State Anxiety (STAI-S, evaluating transient emotional state) and Trait Anxiety (STAI-T, evaluating stable personality trait). Each subscale consists of 20 items rated on a 4-point Likert scale (total score ranges from 20 to 80 per subscale, where higher scores indicate greater anxiety).

    Measured: Assessed at Visit 1 (Day 1) and Visit 2 (approx. Day 30), covering a total study duration of approximately 30 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2026
  2. Study start1 Oct 2026
  3. Primary completion13 Nov 2026 (estimated)
  4. Study completion13 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
A prospective, single-arm, non-randomized interventional study evaluating dental-related stress in children with autism spectrum disorder (ASD) and their parents. All participants complete two subsequent study periods involving routine dental procedures: a baseline visit in a Regular Dental Environment (RDE), followed by a second visit utilizing a Sensory Adapted Dental Environment (SADE) after a 30-day interval. Child stress is measured during each procedure using objective physiological methods, alongside the evaluation of the child's sensory profile and parental stress.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07887243
Sponsor's protocol ID
1065.6120.57.2026
Other IDs
N41/DBS/001611
Acronym
SMILED
Status last verified
Oct 2026
First submitted
7 Oct 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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