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

University of Michigan

Status: Enrolling

Conditions: Behavior; Situational Anxiety

Treatments: Behavioral: Therapy dog presence; Behavioral: Standard-of-care basic behavior guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT06725134

HUM00260476

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

Control

Active Comparator group

Description:

Standard-of-care basic behavior guidance during local anesthesia

Treatment:

Behavioral: Standard-of-care basic behavior guidance

Therapy dog presence

Experimental group

Description:

Therapy dog present during local anesthesia administration

Treatment:

Behavioral: Therapy dog presence