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| Name | Class |
|---|---|
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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A cross-sectional prospective study measuring physiologic biometrics and perceptions of stress during a dental procedure with or without a therapy dog present.
Patients will be consented, enrolled, and assigned to a control group (no dog) or to an experimental group (dog). The patient assigned to the experimental group will be exposed to the therapy animal prior to the dental appointment. Pre-dental procedure and post-dental procedure surveys will be given to all the subjects asking the same questions. Biometric data will be collected by measuring heart rates of the patient/subject during the dental appointment with a Shimmer or Polar device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No exposure to the therapy dog. | |
| Dog Therapy | Experimental | Introduced to a therapy dog and allowed to pet the dog for up to 2 minutes (timed) prior to the dental procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dog Therapy | Other | The intervention is a therapy dog interaction (e.g. petting) for up to 2 minutes before their appointment and first interaction with the doctor. The subject can pet the dog for as long as they like up until the 2 minute mark. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Salivary Amylase Levels Throughout Dental Visit | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. | Up to end of dental visit; a total average between 60 to 90 minutes |
| Mean Salivary Cortisol Levels Throughout Dental Visit | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. | Up to end of dental visit; a total average between 60 to 90 minutes |
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Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
Exclusion Criteria Subjects presenting with any of the following will not be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Laura A Jacox, DMD, PhD, MS | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General & Oral Health Center | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40467121 | Derived | Massouda J, Ghaltakhchyan N, Judd J, Bocklage C, Selden R, TumSuden O, Nanney E, Lee J, Ginnis J, Strauman T, Sawicki C, Hodges EA, Graves C, Divaris K, Jacox L. Evaluating effects of animal-assisted therapy on pediatric dental care patients: A pilot clinical trial. J Am Dent Assoc. 2025 Jun;156(6):447-457.e14. doi: 10.1016/j.adaj.2025.03.006. |
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Deidentified individual data that supports the results will be shared beginning following publication up to 1 year provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
1 month following publication up to 1 year
Deidentified individual data that supports the results will be shared beginning following publication up to 1 year provided the investigator who proposes to use the data has approval from an IRB, IEC, or REB as applicable, and an executed data use/sharing agreement with University of North Carolina (UNC).
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | No exposure to the therapy dog. |
| FG001 | Dog Therapy | Introduced to a therapy dog and allowed to pet the dog for up to 2 minutes (timed) prior to the dental procedure. Dog Therapy: The intervention is a therapy dog interaction (e.g. petting) for up to 2 minutes before their appointment and first interaction with the doctor. The subject can pet the dog for as long as they like up until the 2 minute mark. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | No exposure to the therapy dog. |
| BG001 | Dog Therapy | Introduced to a therapy dog and allowed to pet the dog for up to 2 minutes (timed) prior to the dental procedure. Dog Therapy: The intervention is a therapy dog interaction (e.g. petting) for up to 2 minutes before their appointment and first interaction with the doctor. The subject can pet the dog for as long as they like up until the 2 minute mark. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Salivary Amylase Levels Throughout Dental Visit | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. | Posted | Mean | Standard Deviation | U/mL | Up to end of dental visit; a total average between 60 to 90 minutes |
|
From the time of signing informed consent for this single visit study through post visit survey collection, a total average between 60 to 90 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | No exposure to the therapy dog. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Jacox, DMD, PhD | University of North Carolina at Chapel Hill | 919-966-9731 | ljacox@live.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2024 | Mar 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 12, 2022 | Mar 22, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Mean Salivary Cortisol Levels Throughout Dental Visit | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. | Posted | Mean | Standard Deviation | µg/dL | Up to end of dental visit; a total average between 60 to 90 minutes |
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|
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| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Dog Therapy | Introduced to a therapy dog and allowed to pet the dog for up to 2 minutes (timed) prior to the dental procedure. Dog Therapy: The intervention is a therapy dog interaction (e.g. petting) for up to 2 minutes before their appointment and first interaction with the doctor. The subject can pet the dog for as long as they like up until the 2 minute mark. | 0 | 18 | 0 | 18 | 0 | 18 |
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| 8 minutes after starting dental procedure |
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| 8 minutes after completion of dental procedure |
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| 0.127 |
| Superiority |
| 8 minutes after starting dental procedure | Wilcoxon (Mann-Whitney) | 0.268 | Superiority |
| 8 minutes after completion of dental procedure | Wilcoxon (Mann-Whitney) | 0.353 | Superiority |