Using therapy dogs to reduce anxiety in pediatric dental visits
Animal Assisted Therapy's Effects on Young Dental Patients
This study is testing if having therapy dogs during dental visits can help reduce anxiety in young children aged 4 to 8.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 4 Years to 8 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05464888 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of animal-assisted therapy (AAT) on anxiety levels in children aged 4 to 8 during dental procedures. Participants will be randomly assigned to one of three groups: a control group with no dog present, a short AAT group with a therapy dog for 3 minutes before the visit, or a long AAT group with a therapy dog present throughout the entire dental visit. Physiological metrics such as heart rate and sweat response will be measured using a wireless device, and salivary samples will be collected to assess stress levels. Additionally, surveys will evaluate the children's perceptions of pain and anxiety before and after their dental experience.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 8 who are English-speaking and require a dental exam and cleaning.
Not a fit: Patients younger than 4 or older than 8, non-English speakers, or those unwilling to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce anxiety and improve the dental experience for pediatric patients.
How similar studies have performed: Previous studies have shown positive outcomes with animal-assisted therapy in various settings, suggesting potential success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study: * 4-8 years of age * English speaking * Qualifies for a dental exam and prophylaxis (cleaning) by having not received a dental prophylaxis or oral exam in the past 3 months * Stable physical health, decided at the discretion of the study coordinator and PI * Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based on research site personnel's assessment * 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 Exclusion Criteria: Subjects presenting with any of the following will not be included in the study: * Patients \<4yo and \>8yo * Non-English speakers * Patients unwilling to assent/participate or parental/guardian consent was not given * Self-report or parental report of patient suffering current dental pain * Known allergies or significant adverse reactions following exposure to dogs or the use of oral hygiene products (toothpastes, mouth rinses), and all ingredients in prophy paste * Children who are afraid of dogs or had a prior negative experience with dogs as reported by the parent or child * 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 * Developmental/cognitive disability such that patient cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment
Where this trial is running
Chapel Hill, North Carolina
- General & Oral Health Center — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Laura A Jacox, DMD, PhD, MS — University of North Carolina, Chapel Hill
- Study coordinator: Laura A Jacox, DMD, PhD, MS
- Email: ljacox@live.unc.edu
- Phone: 919-537-3424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.