Trial Outcomes & Findings for Animal Assisted Therapy in Dentistry (NCT NCT04708028)
NCT ID: NCT04708028
Last Updated: 2024-08-19
Results Overview
To measure stress levels salivette swab will be placed in child's cheek to absorb saliva.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Up to end of dental visit; a total average between 60 to 90 minutes
Results posted on
2024-08-19
Participant Flow
Participant milestones
| Measure |
Control
No exposure to the therapy dog.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
18
|
|
Overall Study
COMPLETED
|
21
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Animal Assisted Therapy in Dentistry
Baseline characteristics by cohort
| Measure |
Control
n=21 Participants
No exposure to the therapy dog.
|
Dog Therapy
n=18 Participants
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.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
9.9 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
9.2 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
9.6 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to end of dental visit; a total average between 60 to 90 minutesTo measure stress levels salivette swab will be placed in child's cheek to absorb saliva.
Outcome measures
| Measure |
Control
n=21 Participants
No exposure to the therapy dog.
|
Dog Therapy
n=18 Participants
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.
|
|---|---|---|
|
Mean Salivary Amylase Levels Throughout Dental Visit
Baseline
|
150.82 U/mL
Standard Deviation 135.01
|
166.70 U/mL
Standard Deviation 114.32
|
|
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
|
145.39 U/mL
Standard Deviation 99.02
|
|
Mean Salivary Amylase Levels Throughout Dental Visit
8 minutes after starting dental procedure
|
97.78 U/mL
Standard Deviation 59.65
|
175.11 U/mL
Standard Deviation 144.37
|
|
Mean Salivary Amylase Levels Throughout Dental Visit
8 minutes after completion of dental procedure
|
175.10 U/mL
Standard Deviation 232.24
|
210.05 U/mL
Standard Deviation 188.93
|
PRIMARY outcome
Timeframe: Up to end of dental visit; a total average between 60 to 90 minutesTo measure stress levels salivette swab will be placed in child's cheek to absorb saliva.
Outcome measures
| Measure |
Control
n=21 Participants
No exposure to the therapy dog.
|
Dog Therapy
n=18 Participants
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.
|
|---|---|---|
|
Mean Salivary Cortisol Levels Throughout Dental Visit
Baseline
|
0.185 µg/dL
Standard Deviation 0.255
|
0.155 µg/dL
Standard Deviation 0.090
|
|
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
|
0.154 µg/dL
Standard Deviation 0.112
|
|
Mean Salivary Cortisol Levels Throughout Dental Visit
8 minutes after starting dental procedure
|
0.223 µg/dL
Standard Deviation 0.273
|
0.133 µg/dL
Standard Deviation 0.129
|
|
Mean Salivary Cortisol Levels Throughout Dental Visit
8 minutes after completion of dental procedure
|
0.186 µg/dL
Standard Deviation 0.157
|
0.193 µg/dL
Standard Deviation 0.127
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dog Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Laura Jacox, DMD, PhD
University of North Carolina at Chapel Hill
Phone: 919-966-9731
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place