Anxiety & Depression Association of America

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

Purpose

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.

Conditions

Situational Anxiety
Behavior

Eligibility

Eligible Ages: Between 4 Years and 12 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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 dntal examination is classified as "Definitely Negative" (Frankl 1)

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: University of Michigan

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.