Impact of Therapy Dogs on Child Anxiety and Behavior During Local Anesthesia for Dental Procedures

NCT06725134 | Recruiting

• 1 other identifier: HUM00260476
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Behavior; Situational Anxiety

Keywords

Animal assisted therapy; Pediatric dentistry; Local anesthesia

Outcome Measures

Primary Outcomes (1)

• Behavior (Face, Legs, Activity, Cry, and Consolability scale)

  The subject's behavior from entry into the operatory through one minute following administration of local anesthesia will be evaluated and recorded using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale, with each category scored from 0 to 2. The higher the total score, which ranges from 0 to 10, indicates more distress.

  Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia

Secondary Outcomes (3)

• Heart rate

  Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia

• Anxiety assessment (Modified Faces version of the Modified Child Dental Anxiety scale)

  Upon entering the operatory and after administration of local anesthesia

• Parent questionnaire

  Following injection of local anesthetic

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard-of-care basic behavior guidance during local anesthesia

Behavioral: Standard-of-care basic behavior guidance

Therapy dog presence

EXPERIMENTAL

Therapy dog present during local anesthesia administration

Behavioral: Therapy dog presence

Interventions

Therapy dog presence BEHAVIORAL

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.

Therapy dog presence

Standard-of-care basic behavior guidance BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Dentistry Children's Clinic

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Behavior

Study Officials

• James R. Boynton, DDS, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James R Boynton, DDS, MS

CONTACT

734-764-1523; jboynton@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Dentistry, Department of Pediatric Dentistry, School of Dentistry

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)