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

Sponsor

Medical University of South Carolina (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06057090

Collaborator

(none)

Enrollment

Location

Arms

12.6

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Therapy Animals Dental Anxiety Child Behavior Anesthesia, Local	Behavioral: Therapy Dog	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Other

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

Actual Study Start Date :

Sep 13, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Therapy Dog 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 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.
No Intervention: Control The control group receives standard of care and does not have a therapy dog present in the room during their treatment.

Arm

Intervention/Treatment

Experimental: Therapy Dog

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

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.

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

Behavioral measure, using the Frankl score [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]
Behavior will be recorded using the Frankl score, which ranges from 1 (definitely negative) to 4 (definitely positive)

Secondary Outcome Measures

Parent survey responses [The surveys will be administered immediately after the procedure.]
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.
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]
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.
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]
The participant's heart rate will be recorded, using a finger pulse oximeter
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]
The participant's oxygen saturation will be recorded, using a finger pulse oximeter

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina Pediatric Dental Clinic	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Principal Investigator: Julie L Marshall, PhD, James B. Edwards College of Dental Medicine, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Julie Marshall, PhD, Assistant Professor-Faculty, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT06057090

Other Study ID Numbers:

Pro00129098

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Sep 28, 2023