Using therapy dogs to reduce anxiety in pediatric dental visits

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.