Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients?

Anesthesia, Local Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06057090
• Other study ID #: Pro00129098
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 13, 2023
• Est. completion date: October 2024

Study information

• Verified date: September 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Anxiety Disorders
• Child Behavior
• Dental Anxiety

Intervention

Behavioral:
• Therapy Dog
Certified, volunteer therapy dogs and their handlers will be present in the room during procedures in the experimental arm to see if their presence reduces anxiety and improves behavior in pediatric dental patients.

Locations

Country	Name	City	State
United States	Medical University of South Carolina Pediatric Dental Clinic	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View Citation

Stern J, Pozun A. Pediatric Procedural Sedation. 2023 May 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572100/ — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral measure, using the Frankl score	Behavior will be recorded using the Frankl score, which ranges from 1 (definitely negative) to 4 (definitely positive)	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	Parent survey responses	Parents will be given a short survey about their child's participation in the study. Each arm of the study has its own survey. The survey for the control group is 4 multiple choice questions and one open-ended question. The survey for the experimental group contains 3 multiple choice questions and 1 open-ended question.	The surveys will be administered immediately after the procedure.
Secondary	Microbial concentration	In the experimental arm, the dental operatory will be swabbed prior to the arrival of the therapy dog and again after the therapy dog as left. For the control group, the operatory will be swabbed.	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
Secondary	Anxiety measure, heart rate	The participant's heart rate will be recorded, using a finger pulse oximeter	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
Secondary	Anxiety measure, oxygen saturation	The participant's oxygen saturation will be recorded, using a finger pulse oximeter	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