Clinical trial NCT06057090: Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients?
Official title: Do Certified Therapy Dogs Improve Behavior and Reduce Anxiety in Children Who Receive Administration of a Local Anesthetic for Dental Procedures? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Therapy Animals
Dental Anxiety
Child Behavior
Anesthesia, Local
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to assess whether the presence of a certified therapy dog during dental procedures that require an injection reduces anxiety and improves behavior in pediatric dental patients.

The main questions it aims to answer are:

* Does the presence of a certified therapy dog during dental procedure requiring an injection reduce anxiety and improve behavior in pediatric dental patients?
* How do the parents of pediatric dental patients who participate in the study view the use of a certified therapy dog in their child's treatment?
* Does the presence of a certified therapy dog result in different concentrations of microbes in the treatment room?

All participants will receive standard of care. Researchers will compare the group with a therapy dog present to a group who does not have a therapy dog present to see if heart rate, oxygen saturation, percentage of nitrous oxide administered, and Frankl scores differ between the groups.


Eligibility criteria: Inclusion Criteria:

* Age 3-7
* Children who are patients at the Medical University of South Carolina Department of Pediatric Dentistry
* Children classified as category 1 or 2 according to the American Society of Anesthesiologists Physical Status Classification
* Children whose parents/guardians are willing to consent to the child participating in the study
* Availability of parent to be present during treatment
* Children who require further care that includes the injection of a local anesthetic and whose procedure will take less than one hour

Exclusion Criteria:

* Patients whose cases are considered emergencies
* Patients who are classified as category 3 or higher according to the American Society of Anesthesiologists Physical Status Classification (6)
* If patient's medical status has worsened since initial evaluation
* Known allergy to dogs or other animals
* Past history of dental trauma
* Past history of animal bites or traumatic experience with a dog
* Emotional or developmental delays
* If, on the day of the treatment, patient presents with fever or other illness

Primary outcomes:
measure: Behavioral measure, using the Frankl score
timeFrame: This behavior measure will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure
Secondary outcomes:
measure: Parent survey responses
timeFrame: The surveys will be administered immediately after the procedure.
measure: Microbial concentration
timeFrame: Experimental group: prior to arrival of therapy dog, and after departure of therapy dog. Control group: prior to arrival of participant, after departure of participant
measure: Anxiety measure, heart rate
timeFrame: The heart rate will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure
measure: Anxiety measure, oxygen saturation
timeFrame: Oxygen saturation will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina Pediatric Dental Clinic
state: South Carolina
Study officials:
affiliation: James B. Edwards College of Dental Medicine, Medical University of South Carolina
name: Julie L Marshall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paryab M, Arab Z. The effect of Filmed modeling on the anxious and cooperative behavior of 4-6 years old children during dental treatment: A randomized clinical trial study. Dent Res J (Isfahan). 2014 Jul;11(4):502-7. doi: 10.4103/1735-3327.139426.
citation: Vincent A, Easton S, Sterman J, Farkas K, Heima M. Acceptability and Demand of Therapy Dog Support Among Oral Health Care Providers and Caregivers of Pediatric Patients. Pediatr Dent. 2020 Jan 15;42(1):16-21.
citation: Kamioka H, Okada S, Tsutani K, Park H, Okuizumi H, Handa S, Oshio T, Park SJ, Kitayuguchi J, Abe T, Honda T, Mutoh Y. Effectiveness of animal-assisted therapy: A systematic review of randomized controlled trials. Complement Ther Med. 2014 Apr;22(2):371-90. doi: 10.1016/j.ctim.2013.12.016. Epub 2014 Jan 6.
citation: Casamassimo PS, Seale NS, Rutkauskas Ii JS, Rutkauskas JS. Are U.S. Dentists Adequately Trained to Care for Children? Pediatr Dent. 2018 Mar 15;40(2):93-97.
citation: Stern J, Agarwal A, Pozun A. Pediatric Procedural Sedation. 2025 Mar 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572100/
citation: Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.