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Animal Assisted Therapy for Anxiety in Pediatric Dentistry (AAT Trial)
N/A
Recruiting
Led By Laura A Jacox, DMD, PhD, MS
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
4-8 years of age
Be younger than 18 years old
Must not have
Patients <4yo and >8yo
Non-English speakers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during dental radiograph simulation, approximately 2- 5 minutes.
Awards & highlights
No Placebo-Only Group
Summary
This trial found that having a therapy dog present during a pediatric dental exam, cleaning, and simulated radiographs led to lower perceptions of stress.
Who is the study for?
This trial is for children aged 4-8 who speak English and haven't had a dental exam or cleaning in the last 3 months. They should be healthy, able to follow study procedures, and have their guardian's consent. Kids with severe health issues, allergies to dogs or oral hygiene products, fear of dogs, or those not willing to participate are excluded.
What is being tested?
The study tests how therapy dogs might affect stress levels during dental visits for kids. It compares longer sessions with a dog (Long AAT), shorter ones (Short AAT), and control visits without a dog by measuring stress through physical signs and personal feelings.
What are the potential side effects?
There may not be direct side effects from the interventions since they involve interaction with therapy dogs rather than medication. However, potential indirect effects could include allergic reactions to the dog for those sensitive.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 4 and 8 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am between 4 and 8 years old.
Select...
I do not speak English.
Select...
I am currently experiencing dental pain.
Select...
I am able to understand and follow the study's requirements on my own.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during dental exam, approximately 2- 5 minutes.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during dental exam, approximately 2- 5 minutes.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Heart Rate during Dental Cleaning
Mean Heart Rate during Dental Exam
Mean Heart Rate during Dental Radiograph Simulation
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: +Short AATExperimental Treatment1 Intervention
Children aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 experimental patients who will be interacting with the dog prior to their oral exam.
Group II: +Long AATExperimental Treatment1 Intervention
Children aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 experimental patients who will be interacting with the dog throughout their entire visit.
Group III: Active control; NO dogActive Control1 Intervention
Children aged 4-8 y.o. willing to receive an oral exam, a toothbrush cleaning, simulated radiographs and be a study participant - 75 control patients who will not be interacting with the dog during their visit and will color a dog picture for 3 minutes instead.
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,569 Previous Clinical Trials
4,319,482 Total Patients Enrolled
13 Trials studying Anxiety
4,212 Patients Enrolled for Anxiety
Laura A Jacox, DMD, PhD, MSPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Anxiety
40 Patients Enrolled for Anxiety
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Children who are scared or have had a bad experience with dogs, according to what their parents or they themselves have said.I am between 4 and 8 years old.I do not speak English.I understand and can follow the study's requirements.I am between 4 and 8 years old.I am currently experiencing dental pain.I am able to understand and follow the study's requirements on my own.I haven't had a dental exam or cleaning in the last 3 months.You have had strong allergic reactions to dogs, oral hygiene products like toothpastes and mouth rinses, or any ingredients in prophy paste.
Research Study Groups:
This trial has the following groups:- Group 1: Active control; NO dog
- Group 2: +Short AAT
- Group 3: +Long AAT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.