Animal Assisted Therapy for Anxiety in Pediatric Dentistry

(AAT Trial)

Overseen By S.T. Phillips, BSDH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Non-English speakers, Dental pain, Dog allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

A prospective randomized trial measuring physiologic biometrics and perceptions of stress during a pediatric dental exam, cleaning, and simulated radiographs with or without a therapy dog present.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether participants need to stop taking their current medications.

Is animal-assisted therapy safe for children in dental settings?

Animal-assisted therapy in dental settings is generally considered safe, but there are concerns about hygiene and liability. Most pediatric dentists believe it can improve patient comfort, though it's important to manage these concerns properly. ^{1 2 3 4 5}

How does the 'NO dog' treatment for anxiety in pediatric dentistry differ from other treatments?

The 'NO dog' treatment, also known as standard pediatric dental care, does not include animal-assisted therapy, which has been shown to reduce anxiety in children by having a therapy dog present during dental visits. This approach relies on conventional methods without the calming presence of a therapy animal, which some studies suggest can help lower heart rates and anxiety levels in children. ^{1 2 3 5 6}

What data supports the effectiveness of this treatment for anxiety in pediatric dentistry?

Research shows that having a therapy dog present during dental visits can significantly reduce anxiety in children, as seen by lower heart rates and stable anxiety scores compared to those without a dog. Most pediatric dentists believe that animal-assisted therapy can improve patient comfort and behavior during dental procedures. ^{1 2 3 5 7}

Who Is on the Research Team?

Laura A Jacox, DMD, PhD, MS

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Stable physical health, decided at the discretion of the study coordinator and PI

Evidence of a personally signed and dated informed assent form from the child and legal guardian's consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial and all of their questions have been answered

I understand and can follow the study's requirements.

Exclusion 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.

Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a dental exam, cleaning, and simulated radiographs with or without a therapy dog present. Biometric data and salivary samples are collected.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for stress levels through salivary cortisol and amylase measurements, and heart rate monitoring during the dental procedures.

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active control; NO dog
• Long AAT
• Short AAT

Trial Overview 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.

How Is the Trial Designed?

Group I: +Short AAT Experimental Treatment 1 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 AAT Experimental Treatment 1 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 dog Active Control 1 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.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

A study involving 16 anxious children aged 6 to 12 showed that the presence of a certified therapy dog during dental examinations significantly improved patient compliance and satisfaction, with all participants completing their visits successfully.

Salivary cortisol levels, an indicator of stress, decreased more in the presence of the therapy dog (30% reduction) compared to when the dog was absent (20% reduction), suggesting that therapy dogs can help reduce anxiety in pediatric dental patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoral clinical examinations of pediatric patients with anticipatory anxiety and situational fear facilitated by therapy dog assistance: A pilot RCT. Gussgard, AM., Carlstedt, K., Meirik, M.[2023]

A survey of pediatric dentists revealed that 92% believe animal-assisted therapy (AAT) could enhance patient comfort during dental visits, with 67% expecting a moderate to strong improvement.

Despite the positive outlook, concerns about hygiene and liability were significant, with 26% of respondents citing these as major reservations regarding the implementation of AAT in their practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations for Utilizationof Animal-Assisted Therapy in Pediatric Dentistry Practice. Guram, JS., Williams, DS., Marshall, JL.[2023]

In a study involving 20 children undergoing dental treatment, dog-assisted therapy (AAT) significantly reduced heart rates, indicating lower anxiety levels during procedures compared to a control group that did not receive AAT.

While the control group experienced increased anxiety before and after treatment, the AAT group maintained stable anxiety levels, suggesting that AAT could be an effective method for managing anxiety in pediatric dental care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dog-assisted therapy for control of anxiety in pediatric dentistry. Pinheiro, SL., Silva, C., Luiz, L., et al.[2023]

A study involving 20 children aged 4-11 years demonstrated that a 15-minute exposure to animal-assisted activities in a dental waiting area significantly reduced anxiety levels before dental procedures.

The findings suggest that pet therapy can be an effective method for managing anxiety in pediatric dental patients, contributing to a more positive dental experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A bite out of anxiety: Evaluation of animal-assisted activity on anxiety in children attending a pediatric dental outpatient unit. Nammalwar, RB., Rangeeth, P.[2022]

In a study involving 102 children aged 5 to 10 undergoing simple dental procedures, the presence of a therapy dog significantly reduced dental anxiety, as measured by pulse rate and anxiety rating scales (p < 0.001).

Animal-assisted therapy not only helps in managing anxiety during dental visits but also shows promise for long-term behavior management and is well-accepted by both children and their parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of dental anxiety in children between 5 and 10 years of age in the presence of a therapy dog: a randomized controlled clinical study. Thakkar, TK., Naik, SN., Dixit, UB.[2021]

The study identifies four main categories of potential risks associated with having therapy dogs in dental clinics, including zoonotic pathogens, allergens, adverse animal behavior, and dangers from high activity in a crowded environment.

Despite these risks, the study concludes that they can be effectively managed through awareness and adherence to best practices by dental staff and dog handlers, ensuring a safe environment for both patients and the therapy dog.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dog-assisted therapy in the dental clinic: Part A-Hazards and assessment of potential risks to the health and safety of humans. Gussgard, AM., Weese, JS., Hensten, A., et al.[2023]

A systematic review of three studies involving 146 children found no significant evidence that animal-assisted therapy (AAT) reduces anxiety during dental treatments, as the anxiety levels were similar whether AAT was present or not.

The studies had a high risk of bias, particularly in randomization and outcome measurement, indicating a need for more rigorous research with larger sample sizes to better assess the efficacy of AAT in reducing anxiety in children during dental care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does use of animal therapy during dental care help to reduce anxiety in children and adolescents? A systematic review. Ribeiro, CDPV., Alves, JB., Kominami, PA., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Intraoral clinical examinations of pediatric patients with anticipatory anxiety and situational fear facilitated by therapy dog assistance: A pilot RCT. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Considerations for Utilizationof Animal-Assisted Therapy in Pediatric Dentistry Practice. [2023]

3. Singapore pubmed.ncbi.nlm.nih.gov

Dog-assisted therapy for control of anxiety in pediatric dentistry. [2023]

4. India pubmed.ncbi.nlm.nih.gov

A bite out of anxiety: Evaluation of animal-assisted activity on anxiety in children attending a pediatric dental outpatient unit. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Assessment of dental anxiety in children between 5 and 10 years of age in the presence of a therapy dog: a randomized controlled clinical study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Dog-assisted therapy in the dental clinic: Part A-Hazards and assessment of potential risks to the health and safety of humans. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Does use of animal therapy during dental care help to reduce anxiety in children and adolescents? A systematic review. [2023]