Recruiting

Therapy Dogs

Sponsor:

University of Michigan

Code:

NCT06725134

Conditions

Situational Anxiety

Behavior

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Accepted

Interventions

Therapy dog presence

Standard-of-care basic behavior guidance

Study Details

Brief summary:

Therapy dogs in dental offices might help anxious children during dental care. Therapy dogs might help children during injection of local anesthetic, when we inject numbing medication before working on the teeth. The goal of this study is to learn if having a therapy dog with a child during the injection of numbing medication helps children to be more comfortable at the dentist's office. This study is of children who need dental care using local anesthesia. Study participant's behavioral reactions and heart rate during injection of local anesthetic with and without having a therapy dog present will be recorded and children and their guardians will be asked a few short questions about the injection and therapy dog after injection.

Conditions

Situational Anxiety

Behavior

Study ID

NCT06725134

Start date

Nov 1, 2024

Status verified date

Nov, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age range: children aged 4- to 12-years
  • Health status: healthy children without significant medical conditions (ASA I or ASA II)
  • Dental procedure: children scheduled for at least two dental procedures requiring local anesthesia
  • Consent: written informed consent from the parent or legal guardian
  • Verbal assent from potential subjects age 4-9 years; written assent for children age 10-12 years

Exclusion Criteria:

  • Allergies: children with known allergies to dogs or animal dander
  • Children with a fear or phobia of dogs
  • Children with a behavioral disorder which may negatively impact response to the presence of a therapy dog
  • Previous exposure: children who have previously undergone dental procedures with local anesthesia in the presence of a therapy dog
  • Medical conditions: children with medical conditions that might affect their vital signs independently of the dental procedure (e.g., heart conditions)
  • Parental discomfort: cases where parents are uncomfortable with the presence of a therapy dog during the procedure
  • Advanced behavior guidance is indicated: children whose behavior for dental examination is classified as "Definitely Negative" (Frankl 1)

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

Standard-of-care basic behavior guidance during local anesthesia

experimental: Therapy dog presence

Therapy dog present during local anesthesia administration

Interventions

Therapy dog presence

A trained therapy dog will be present during the child's dental appointment. The dog will be in the operatory as the child enters the room and will lie on the child during injection of local anesthesia.

Standard-of-care basic behavior guidance

Basic behavior guidance as defined by the American Academy of Pediatric Dentistry includes strategies to help children cope through potentially stressful dental procedures. These strategies include tell-show-do, positive reinforcement, parental presence, and nitrous oxide/oxygen analgesia, among others.

Primary outcome measure

  • Behavior (Face, Legs, Activity, Cry, and Consolability scale) [ Time Frame: Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia ]

Central Contacts and Locations

Central contacts

James R Boynton, DDS, MS

734-764-1523jboynton@umich.edu

Locations

University of Michigan School of Dentistry Children's Clinic

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

James R Boynton, DDS, MS

734-764-1523jboynton@umich.edu

More Information

Sponsor

University of Michigan

Last update posted

Dec 3, 2025

Last verified

Nov, 2025

Keywords

  • Animal assisted therapy
  • Pediatric dentistry
  • Local anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-12-03.