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

NCT07887243 | Active Not Recruiting

• 2 other identifiers: 1065.6120.57.2026N41/DBS/001611
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism; Sensory Integration Disorder; Autism Disorders and Maternal Stress; Stress Biomarkers

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

Outcome Measures

Primary Outcomes (8)

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

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

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

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

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

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

• 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.

  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.

• 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.

  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)

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

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

• Child Sensory Profile (SSP-2)

  Assessed at baseline during Visit 1 (Day 1).

• Child Emotional State

  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.

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

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

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

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

Study Arms (1)

SADE Intervention Group

EXPERIMENTAL

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).

Behavioral: Sensory-Adapted Dental Environment

Interventions

Sensory-Adapted Dental Environment BEHAVIORAL

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.

Also known as: SADE, Multi-sensory dental adaptation

SADE Intervention Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

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

Krakow, Lesser Poland Voivodeship, 31-155, Poland

Location

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Iwona Gregorczyk-Maga, Professor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lekarz dentysta

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2026
• First Posted: October 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): November 13, 2026
• Study Completion (Estimated): November 13, 2026
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

PL (1)