Therapy Dogs for Childhood Dental Anxiety

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Allergy to dogs, Dental trauma, Developmental delays, 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: 2

Duration: 1 day

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of therapy dogs in reducing dental anxiety in children?

Research shows that therapy dogs can help reduce anxiety in children during dental visits. In one study, children who interacted with therapy dogs had lower heart rates and maintained stable anxiety levels compared to those who did not. Another study found that therapy dogs improved children's behavior and comfort during dental procedures. ^{1 2 3 4 5}

Is therapy dog use safe for children in dental settings?

Research on therapy dogs in dental settings shows they can help reduce anxiety in children without any reported safety issues for the children. However, there are potential risks to the health and safety of the therapy dogs themselves in a dental clinic environment. ^{1 2 3 5 6}

How does therapy dog treatment differ from other treatments for childhood dental anxiety?

Therapy dog treatment is unique because it involves the presence of a specially trained dog to help reduce anxiety in children during dental visits, unlike traditional methods that may rely on verbal reassurance or sedation. This approach uses the calming effect of animal companionship to improve children's behavior and comfort during dental procedures. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this clinical trial is to assess whether the presence of a certified therapy dog during dental procedures that require an injection reduces anxiety and improves behavior in pediatric dental patients. The main questions it aims to answer are: * Does the presence of a certified therapy dog during dental procedure requiring an injection reduce anxiety and improve behavior in pediatric dental patients? * How do the parents of pediatric dental patients who participate in the study view the use of a certified therapy dog in their child's treatment? * Does the presence of a certified therapy dog result in different concentrations of microbes in the treatment room? All participants will receive standard of care. Researchers will compare the group with a therapy dog present to a group who does not have a therapy dog present to see if heart rate, oxygen saturation, percentage of nitrous oxide administered, and Frankl scores differ between the groups.

Research Team

Julie L Marshall, PhD

Principal Investigator

James B. Edwards College of Dental Medicine, Medical University of South Carolina

Eligibility Criteria

This trial is for children aged 3-7 who are dental patients at the Medical University of South Carolina, with no severe medical conditions or allergies to dogs. They must need a dental procedure under local anesthesia lasting less than an hour and have a parent available during treatment.

Inclusion Criteria

I am between 3 and 7 years old.

Children who are patients at the Medical University of South Carolina Department of Pediatric Dentistry

Children classified as category 1 or 2 according to the American Society of Anesthesiologists Physical Status Classification

Exclusion Criteria

Patients whose cases are considered emergencies

Known allergy to dogs or other animals

I have had a dental injury in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo dental procedures with or without the presence of a certified therapy dog to assess anxiety and behavior

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 day

1 visit (in-person)

Treatment Details

Interventions

• Therapy Dog

Trial Overview The study tests if having a therapy dog in the room during pediatric dental procedures can reduce anxiety and improve behavior. It compares kids getting standard care with those accompanied by a therapy dog, measuring heart rate, oxygen levels, nitrous oxide use, and behavior scores.

Participant Groups

Group I: Therapy Dog Experimental Treatment 1 Intervention

This group will have a certified therapy dog present in the treatment room throughout the procedure. Prior to the procedure, the participant will be briefly introduced to the therapy dog and handler, who will remain in the room until the end of the procedure.

Group II: Control Active Control 1 Intervention

The control group receives standard of care and does not have a therapy dog present in the room during their treatment.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Findings from Research

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]

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]

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]

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]

Dental therapy dogs can help reduce anxiety in patients during dental visits, but there are potential health and safety risks for the dogs in the clinic environment, including allergies, sharps injuries, and stress from erratic patient behavior.

Implementing best practices, such as training for both clinic staff and dog handlers, can minimize these risks and ensure a safer experience for therapy dogs in dental settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

References

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. Singapore pubmed.ncbi.nlm.nih.gov

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

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

A Randomized Controlled Pilot Study Examining Effects of Animal Assisted Therapy in Children Undergoing Sealant Placement. [2021]

4. 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]

5. 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]

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

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