Clinical trial NCT06725134: Impact of Therapy Dogs on Child Anxiety and Behavior During Local Anesthesia for Dental Procedures
Official title: Impact of Therapy Dogs on Anxiety and Behavior of Pediatric Dental Patients During Local Anesthesia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Situational Anxiety
Behavior
Keywords: Animal assisted therapy
Pediatric dentistry
Local anesthesia
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 25
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Behavior (FLACC scale)
timeFrame: Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia
Secondary outcomes:
measure: Heart rate
timeFrame: Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia
measure: Anxiety assessment (MCDASF)
timeFrame: Upon entering the operatory and after administration of local anesthesia
measure: Parent questionnaire
timeFrame: Following injection of local anesthetic
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry Children's Clinic
state: Michigan
Study officials:
References: