RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-01
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06725134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Age range: children aged 4- to 12-years
  2. * Health status: healthy children without significant medical conditions (ASA I or ASA II)
  3. * Dental procedure: children scheduled for at least two dental procedures requiring local anesthesia
  4. * Consent: written informed consent from the parent or legal guardian
  5. * Verbal assent from potential subjects age 4-9 years; written assent for children age 10-12 years
  1. * Allergies: children with known allergies to dogs or animal dander
  2. * Children with a fear or phobia of dogs
  3. * Children with a behavioral disorder which may negatively impact response to the presence of a therapy dog
  4. * Previous exposure: children who have previously undergone dental procedures with local anesthesia in the presence of a therapy dog
  5. * Medical conditions: children with medical conditions that might affect their vital signs independently of the dental procedure (e.g., heart conditions)
  6. * Parental discomfort: cases where parents are uncomfortable with the presence of a therapy dog during the procedure
  7. * Advanced behavior guidance is indicated: children whose behavior for dental examination is classified as "Definitely Negative" (Frankl 1)

Contacts and Locations

Study Contact

James R Boynton, DDS, MS
CONTACT
734-764-1523
jboynton@umich.edu

Principal Investigator

James R. Boynton, DDS, MS
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan School of Dentistry Children's Clinic
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • James R. Boynton, DDS, MS, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01
Study Completion Date2027-07

Study Record Updates

Study Start Date2024-11-01
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Animal assisted therapy
  • Pediatric dentistry
  • Local anesthesia

Additional Relevant MeSH Terms

  • Situational Anxiety
  • Behavior