Anxiety
Conditions
Brief summary
A cross-sectional prospective study measuring physiologic biometrics and perceptions of stress during a dental procedure with or without a therapy dog present.
Detailed description
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.
Interventions
OTHERDog 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.
Sponsors
North Carolina Translational and Clinical Sciences Institute
University of North Carolina, Chapel Hill
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study: * 7-17 years of age * Patient undergoing 1 quadrant restorative dental procedure requiring a handpiece (e.g. multiple fillings, sealants and/or stainless-steel crowns) and/or extraction(s) * History of moderate dental anxiety with a Frankl score of 2-3 based on Epic chart review
Exclusion criteria
Subjects presenting with any of the following will not be included in the study: * Patients with developmental delay/special needs, Autism Spectrum Disorders (ASDs), craniofacial defects, chronic pain conditions, and/or dental syndromes * No history of dental anxiety * Moderate to severe allergy to dogs * Previous traumatic experience with a dog and/or self-reported fear of dogs * Patients who are not receiving dental care requiring a handpiece (for ex, prophylaxis only) * Patients with severe, documented xerostomia * Patients receiving sedation (pharmacological and conscious sedation) or general anesthesia * Patients who will have physical restraints placed during the dental procedure * Patient scheduled to have sedation or general anesthesia * Severe acute or chronic medical or psychiatric condition(s) that would interfere with the interpretation of results, and in the judgement of the Investigator, would make the subject inappropriate for entry into the trial * Patient with developmental/cognitive disability that cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment. * Inability or unwillingness of individual and legal guardian/representative to give written informed assent (from child) and consent (from adult).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Salivary Amylase Levels Throughout Dental Visit | Up to end of dental visit; a total average between 60 to 90 minutes | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. |
| Mean Salivary Cortisol Levels Throughout Dental Visit | Up to end of dental visit; a total average between 60 to 90 minutes | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control No exposure to the therapy dog. | 21 |
| 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. | 18 |
| Total | 39 |
Baseline characteristics
| Characteristic | Control | Dog Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 21 Participants | 18 Participants | 39 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.9 years STANDARD_DEVIATION 2 | 9.2 years STANDARD_DEVIATION 2.1 | 9.6 years STANDARD_DEVIATION 2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 14 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 4 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 13 Participants | 26 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 2 Participants | 6 Participants |
| Region of Enrollment United States | 21 Participants | 18 Participants | 39 Participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 23 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 18 |
| other Total, other adverse events | 0 / 22 | 0 / 18 |
| serious Total, serious adverse events | 0 / 22 | 0 / 18 |
Outcome results
Primary
Mean Salivary Amylase Levels Throughout Dental Visit
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva.
Time frame: Up to end of dental visit; a total average between 60 to 90 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Mean Salivary Amylase Levels Throughout Dental Visit | Baseline | 150.82 U/mL | Standard Deviation 135.01 |
| Control | Mean Salivary Amylase Levels Throughout Dental Visit | 8 minutes Post intervention (Dog exposure or no dog exposure) | 127.77 U/mL | Standard Deviation 92.46 |
| Control | Mean Salivary Amylase Levels Throughout Dental Visit | 8 minutes after starting dental procedure | 97.78 U/mL | Standard Deviation 59.65 |
| Control | Mean Salivary Amylase Levels Throughout Dental Visit | 8 minutes after completion of dental procedure | 175.10 U/mL | Standard Deviation 232.24 |
| Dog Therapy | Mean Salivary Amylase Levels Throughout Dental Visit | 8 minutes after completion of dental procedure | 210.05 U/mL | Standard Deviation 188.93 |
| Dog Therapy | Mean Salivary Amylase Levels Throughout Dental Visit | Baseline | 166.70 U/mL | Standard Deviation 114.32 |
| Dog Therapy | Mean Salivary Amylase Levels Throughout Dental Visit | 8 minutes after starting dental procedure | 175.11 U/mL | Standard Deviation 144.37 |
| Dog Therapy | Mean Salivary Amylase Levels Throughout Dental Visit | 8 minutes Post intervention (Dog exposure or no dog exposure) | 145.39 U/mL | Standard Deviation 99.02 |
Comparison: Baselinep-value: 0.379Wilcoxon (Mann-Whitney)
Comparison: 8 minutes Post intervention (Dog exposure or no dog exposure)p-value: 0.646Wilcoxon (Mann-Whitney)
Comparison: 8 minutes after starting dental procedurep-value: 0.219Wilcoxon (Mann-Whitney)
Comparison: 8 minutes after completion of dental procedurep-value: 0.223Wilcoxon (Mann-Whitney)
Primary
Mean Salivary Cortisol Levels Throughout Dental Visit
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva.
Time frame: Up to end of dental visit; a total average between 60 to 90 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Mean Salivary Cortisol Levels Throughout Dental Visit | 8 minutes after starting dental procedure | 0.223 µg/dL | Standard Deviation 0.273 |
| Control | Mean Salivary Cortisol Levels Throughout Dental Visit | 8 minutes Post intervention (Dog exposure or no dog exposure) | 0.153 µg/dL | Standard Deviation 0.219 |
| Control | Mean Salivary Cortisol Levels Throughout Dental Visit | 8 minutes after completion of dental procedure | 0.186 µg/dL | Standard Deviation 0.157 |
| Control | Mean Salivary Cortisol Levels Throughout Dental Visit | Baseline | 0.185 µg/dL | Standard Deviation 0.255 |
| Dog Therapy | Mean Salivary Cortisol Levels Throughout Dental Visit | 8 minutes after completion of dental procedure | 0.193 µg/dL | Standard Deviation 0.127 |
| Dog Therapy | Mean Salivary Cortisol Levels Throughout Dental Visit | 8 minutes Post intervention (Dog exposure or no dog exposure) | 0.154 µg/dL | Standard Deviation 0.112 |
| Dog Therapy | Mean Salivary Cortisol Levels Throughout Dental Visit | 8 minutes after starting dental procedure | 0.133 µg/dL | Standard Deviation 0.129 |
| Dog Therapy | Mean Salivary Cortisol Levels Throughout Dental Visit | Baseline | 0.155 µg/dL | Standard Deviation 0.09 |
Comparison: Baselinep-value: 0.41Wilcoxon (Mann-Whitney)
Comparison: 8 minutes Post intervention (Dog exposure or no dog exposure)p-value: 0.127Wilcoxon (Mann-Whitney)
Comparison: 8 minutes after starting dental procedurep-value: 0.268Wilcoxon (Mann-Whitney)
Comparison: 8 minutes after completion of dental procedurep-value: 0.353Wilcoxon (Mann-Whitney)