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

NCT06057090 | Terminated

• 1 other identifier: Pro00129098
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Therapy Animals; Dental Anxiety; Child Behavior; Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Parent survey responses

  The surveys will be administered immediately after the procedure.

• Microbial concentration

  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

• Anxiety measure, heart rate

  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

• Anxiety measure, oxygen saturation

  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

Study Arms (2)

Therapy Dog

EXPERIMENTAL

This group will have a certified therapy dog present in the treatment room throughout the procedure. Prior to the procedure, the participant will be briefly introduced to the therapy dog and handler, who will remain in the room until the end of the procedure.

Behavioral: Therapy Dog

Control

NO INTERVENTION

The control group receives standard of care and does not have a therapy dog present in the room during their treatment.

Interventions

Therapy Dog BEHAVIORAL

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.

Therapy Dog

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina Pediatric Dental Clinic

Charleston, South Carolina, 29425, United States

Location

Related Publications (6)

• 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.

  PMID: 25225565 BACKGROUND

• 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.

  PMID: 32075705 BACKGROUND

• 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.

  PMID: 24731910 BACKGROUND

• 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.

  PMID: 29663907 BACKGROUND

• Stern J, Agarwal A, Pozun A. Pediatric Procedural Sedation. 2025 Mar 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572100/

  PMID: 34283466 BACKGROUND

• 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.

  PMID: 20332509 BACKGROUND

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Julie L Marshall, PhD

  James B. Edwards College of Dental Medicine, Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: September 28, 2023
• Study Start: September 13, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)