Trial · NCT07887243
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| 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). |
| Secondary | 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. | 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. |
| Secondary | 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. | 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. |
| Secondary | 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. | 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. |
| Secondary | Change in Parental 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 parental physiological stress during dental visits in RDE versus SADE conditions. |
| Secondary | Change in Parental Skin Temperature 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 parental physiological stress during dental visits in RDE versus SADE conditions. |
| Secondary | Change in Parental 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 parental physical restlessness during dental visits in RDE versus SADE conditions. |
| Secondary | Change in Parental 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 parental energy expenditure measured in MET values via Empatica EmbracePlus during dental visits in RDE versus SADE conditions. |
| Secondary | Change in Parental 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 parental stress changes between RDE and SADE visits. |
| Secondary | Change in Parental 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 cparental stress changes between RDE and SADE visits. |
| Secondary | Parental Stress Level (PSI-4 or SIPA) | Assessed at baseline during Visit 1 (Day 1). | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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