An interventional study of Sensory-Adapted Dental Environment in Autism, Autism Disorders and Maternal Stress and Sensory Integration Disorder, sponsored by Jagiellonian University. Active, not recruiting at 1 site in Poland. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Jagiellonian University · Not applicable, Interventional, and Supportive care
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:
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 2 (Sensory-Adapted Dental Environment - SADE): Conducted in a single-chair operatory modified with specific sensory interventions:
Objective and Subjective Outcome Measures: Both visits will incorporate simultaneous real-time objective and subjective stress assessments for both the child and the parent:
Behavioral and Psychological Assessments:
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.
1,360 studies on the registry are indexed under Autistic Disorder; 332 are open to participants now.
This study's planned enrollment of 40 is below the median of 46 across 1,058 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Jagiellonian University is the lead sponsor of 160 studies on the registry; 35 are open to participants now.
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Child Inclusion Criteria
Parent/Legal Guardian Inclusion Criteria
Exclusion Criteria:
Child Exclusion Criteria
Parent/Legal Guardian Exclusion Criteria
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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).
Time frame: 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)
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).
Time frame: Assessed at baseline during Visit 1 (Day 1).
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.
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.
Time frame: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.
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.
Time frame: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.
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.
Time frame: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.
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.
Time frame: Measured continuously in real-time during both dental visits (Visit 1 and Visit 2), approx. 30-90 minutes per visit.
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.
Time frame: 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 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.
Time frame: 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.
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.
Time frame: Assessed at baseline during Visit 1 (Day 1).
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.
Time frame: Assessed at baseline during Visit 1 (Day 1).
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).
Time frame: Assessed at Visit 1 (Day 1) and Visit 2 (approx. Day 30), covering a total study duration of approximately 30 days.
Plan to share: Undecided
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