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

Impact of Therapy Dogs on Anxiety and Behavior of Pediatric Dental Patients During Local Anesthesia: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Behavior; Situational Anxiety
• Intervention / Treatment: Behavioral: Standard-of-care basic behavior guidance; Behavioral: Therapy dog presence

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James R Boynton, DDS, MS; Phone Number: 734-764-1523; Email: jboynton@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan School of Dentistry Children's Clinic
      • Contact: James R Boynton, DDS, MS; Phone Number: 734-764-1523; Email: jboynton@umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Standard-of-care basic behavior guidance during local anesthesia	Behavioral: 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.
Experimental: Therapy dog presence; Therapy dog present during local anesthesia administration	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	The subject's heart rate will be monitored and recorded every 30 seconds from entry into the operatory through one minute following administration of local anesthesia.	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)	The subject will be asked to complete an anxiety assessment using the revised modified faces version of the modified child dental anxiety scale (MCDASF). This questionnaire has two questions which are each answered on a five-point scale (range 1-5 for each question for a total range of 2-10). Higher values represent more distress.	Upon entering the operatory and after administration of local anesthesia
Parent questionnaire	The subject's parent will be asked four questions regarding their child's anxiety and the therapy dog (if present). These four questions are not scaled. The questions are: Do you think your child was anxious for local anesthesia? Y/N; Do you think the therapy dog reduced your child's dental anxiety during local anesthesia? Yes/No; Would you want a therapy dog present for future dental treatment appointments? Yes/No; How do you think your child fees post-local anesthesia? Very Anxious/Anxious/Neutral/Calm/Very Calm.	Following injection of local anesthetic

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: James R. Boynton, DDS, MS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Local anesthesia; Pediatric dentistry; Animal assisted therapy
• Additional Relevant MeSH Terms: Mental Disorders; Behavior
• Other Study ID Numbers: HUM00260476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No