Trial · NCT07887243

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

NCT07887243, Not applicable, Active not recruiting, Jagiellonian University

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Adapting the Sensory Environment to Reduce Stress in Children With Autism During Dental Visits. Trials, record NCT07887243. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07887243

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Adapting the Sensory Environment to Reduce Stress in Children With Autism During Dental Visits
NCT number: NCT07887243
Status: Active not recruiting
Phases: Not applicable
Enrollment: 40 participants, estimated
Lead sponsor: Jagiellonian University
Conditions: Autism, Autism Disorders and Maternal Stress, Sensory Integration Disorder, Stress Biomarkers
Interventions: Sensory-Adapted Dental Environment
First posted: 2026-10-21
Last updated: 2026-10-21

Source ClinicalTrials.gov

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Child 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.	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.
Primary	Change in Child 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.	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.
Primary	Change in Child Respiration Rate (RR) 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.	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.
Primary	Change in Child Skin Temperature (ST) 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.	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.
Primary	Change in Child Actigraphy-Derived Physical Activity Metrics 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.	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.
Primary	Change in Child Metabolic Equivalent of Task (MET) 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.	Estimation of child energy expenditure measured in MET values via Empatica EmbracePlus during dental visits in RDE versus SADE conditions.
Primary	Change in Child Salivary Lysozyme Levels	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.	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.
Primary	Change in Child Salivary Cortisol Levels	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.	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.
Secondary	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.	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).
Secondary	Child Sensory Profile (SSP-2)	Assessed at baseline during Visit 1 (Day 1).	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).

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07887243

GET https://conductscience.org/api/trials/v1/NCT07887243/registered?page=2

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