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

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.

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:2026-07
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 dntal 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

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

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 Date2026-07

Study Record Updates

Study Start Date2024-11-01
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • Animal assisted therapy
  • Pediatric dentistry
  • Local anesthesia

Additional Relevant MeSH Terms

  • Situational Anxiety
  • Behavior