Therapy Dogs for Situational Anxiety

Overseen By James R Boynton, DDS, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Dog allergies, Dog phobia, Behavioral disorder, Heart conditions, 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: Single session

25 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 the treatment Therapy Dogs for Situational Anxiety?

Research shows that spending time with therapy dogs can help reduce anxiety in various settings, including hospitals and dental care for children. The calming effect of interacting with therapy dogs has been observed in different patient groups, suggesting it could be beneficial for situational anxiety as well. ^{1 2 3 4 5}

Is therapy dog treatment safe for humans?

Research on therapy dogs in settings like dental clinics and hospitals suggests that while they can help reduce anxiety, there are potential risks and hazards to consider for both humans and the dogs involved. ^{1 2 4 6 7}

How is therapy dog treatment different from other treatments for situational anxiety?

Therapy dog treatment is unique because it involves interaction with a trained dog and its handler to help reduce anxiety, offering a non-drug alternative that can be particularly beneficial for those who prefer not to use medication. This approach is different from traditional treatments like medication or talk therapy, as it provides comfort and emotional support through the presence of a friendly animal. ^{1 4 6 7 8}

What is the purpose of this trial?

Children undergoing dental restorative or surgical procedures require injection of local anesthetic. The injection procedure is often the most anxiety-producing stimulus for children during dental care, when children demonstrate the highest level of emotional distress. Several studies have investigated various interventions, such as distraction, hypnosis, and cognitive behavioral therapy to ease this stress. Animal-assisted therapy (e.g. the presence of a therapy dog) may be a promising strategy for managing anxiety in young dental patients. However, no studies have explored the potential benefits of using therapy dogs specifically during the administration of local anesthesia in pediatric dental patients. The objective of this randomized controlled trial is to investigate the effects of therapy dogs on pediatric dental patients during local anesthesia administration.

Eligibility Criteria

This trial is for children who experience anxiety or behavioral issues when facing dental procedures that require local anesthesia. It's not specified who can't participate, so it's important to check with the study organizers for any exclusion criteria.

Inclusion Criteria

Consent: written informed consent from the parent or legal guardian

I am between 4 and 12 years old.

My child is scheduled for two dental procedures with local anesthesia.

Exclusion Criteria

My child has a behavior disorder that might not mix well with therapy dogs.

My parents are not comfortable with a therapy dog being present during my procedure.

My child needs special help to manage their behavior at the dentist.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive local anesthesia with or without the presence of a therapy dog

Single session

1 visit (in-person)

Follow-up

Participants are monitored for anxiety and behavior post-treatment

Immediate post-treatment

1 visit (in-person)

Treatment Details

Interventions

• Therapy Dog

Trial Overview The trial is testing if having a therapy dog present can help reduce anxiety and improve behavior in kids during the administration of local anesthesia in dental settings compared to standard behavior guidance methods.

Participant Groups

Group I: Therapy dog presence Experimental Treatment 1 Intervention

Therapy dog present during local anesthesia administration

Group II: Control Active Control 1 Intervention

Standard-of-care basic behavior guidance during local anesthesia

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Findings from Research

A study involving 230 hospitalized psychiatric patients found that a single session of animal-assisted therapy significantly reduced anxiety levels across various diagnoses, including psychotic and mood disorders.

In contrast, a regular therapeutic recreation session only reduced anxiety for patients with mood disorders, indicating that animal-assisted therapy may be more broadly effective for anxiety reduction in psychiatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of animal-assisted therapy on anxiety ratings of hospitalized psychiatric patients. Barker, SB., Dawson, KS.[2020]

A study involving patients from Behavioral Health and Pediatrics units showed that spending time with a therapy dog significantly reduced anxiety levels, as measured by the State Anxiety Scale.

Both adult and child participants experienced a notable decrease in anxiety after a 15-minute interaction with the therapy dog, supporting the effectiveness of pet therapy as an intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Pet Therapy to Decrease Patients' Anxiety on Two Diverse Inpatient Units. Mulvaney-Roth, P., Jackson, C., Bert, L., 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]

In a clinical trial with 80 emergency department patients, exposure to therapy dogs significantly reduced anxiety levels compared to usual care, with anxiety scores dropping from a median of 6 to 2 after 15 minutes with the dog.

Patients who interacted with therapy dogs also showed a trend towards lower pain medication use, with only 1 out of 40 needing pain relief compared to 7 out of 40 in the control group, suggesting potential benefits for pain management as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled clinical trial of canine therapy versus usual care to reduce patient anxiety in the emergency department. Kline, JA., Fisher, MA., Pettit, KL., et al.[2020]

In a pilot study involving 102 patients in psychiatric addiction treatment, the presence of a therapy dog significantly improved social interaction, ward atmosphere, and emotional competencies compared to a control group without the dog.

Patients reported a notable reduction in smoking and cravings when therapy dogs were present, indicating that animal-assisted therapy may enhance treatment outcomes in addiction settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of an animal-assisted intervention on psychiatric in-patient addiction treatment - a pilot study]. Uhlmann, C., Nauss, C., Worbs, A., et al.[2022]

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]

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]

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]

References

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

The effects of animal-assisted therapy on anxiety ratings of hospitalized psychiatric patients. [2020]

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

Using Pet Therapy to Decrease Patients' Anxiety on Two Diverse Inpatient Units. [2023]

3. 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]

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

Controlled clinical trial of canine therapy versus usual care to reduce patient anxiety in the emergency department. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

[Effects of an animal-assisted intervention on psychiatric in-patient addiction treatment - a pilot study]. [2022]

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. 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]

8. 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]