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

Not Applicable

Recruiting

• Conditions: Situational Anxiety; Behavior

• Registration Number: NCT06725134
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-01
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-10
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Behavior (FLACC scale)	Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia	The subject's behavior from entry into the operatory through one minute following administration of local anesthesia will be evaluated and recorded using the FLACC scale.

Secondary Outcome Measures

Name	Time	Method
Heart rate	Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia	The subject's heart rate will be monitored and recorded every 30 seconds from entry into the operatory through one minute following administration of local anesthesia.
Anxiety assessment (MCDASF)	Upon entering the operatory and after administration of local anesthesia	The subject will be asked to complete an anxiety assessment using the revised modified faces version of the modified child dental anxiety scale (MCDASF)
Parent questionnaire	Following injection of local anesthetic	The subject's parent will be asked four questions regarding their child's anxiety and the therapy dog (if present).

Trial Locations

Locations (1)

University of Michigan School of Dentistry Children's Clinic; 🇺🇸 Ann Arbor, Michigan, United States