Back to resultsDo Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients?
Primary Purpose
Therapy Animals, Dental Anxiety, Child Behavior
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapy Dog
Sponsored by
About this trial
This is an interventional other trial for Therapy Animals
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
Sites / Locations
- Medical University of South Carolina Pediatric Dental Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Therapy Dog
Control
Arm Description
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.
The control group receives standard of care and does not have a therapy dog present in the room during their treatment.
Outcomes
Primary Outcome Measures
Behavioral measure, using the Frankl score
Behavior will be recorded using the Frankl score, which ranges from 1 (definitely negative) to 4 (definitely positive)
Secondary Outcome Measures
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.
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.
Anxiety measure, heart rate
The participant's heart rate will be recorded, using a finger pulse oximeter
Anxiety measure, oxygen saturation
The participant's oxygen saturation will be recorded, using a finger pulse oximeter
Full Information
NCT ID
NCT06057090
First Posted
August 9, 2023
Last Updated
September 21, 2023
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT06057090
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 13, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Therapy Animals, Dental Anxiety, Child Behavior, Anesthesia, Local
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapy Dog
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group receives standard of care and does not have a therapy dog present in the room during their treatment.
Intervention Type
Behavioral
Intervention Name(s)
Therapy Dog
Intervention Description
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.
Primary Outcome Measure Information:
Title
Behavioral measure, using the Frankl score
Description
Behavior will be recorded using the Frankl score, which ranges from 1 (definitely negative) to 4 (definitely positive)
Time Frame
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 Outcome Measure Information:
Title
Parent survey responses
Description
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.
Time Frame
The surveys will be administered immediately after the procedure.
Title
Microbial concentration
Description
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.
Time Frame
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
Title
Anxiety measure, heart rate
Description
The participant's heart rate will be recorded, using a finger pulse oximeter
Time Frame
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
Title
Anxiety measure, oxygen saturation
Description
The participant's oxygen saturation will be recorded, using a finger pulse oximeter
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie L Marshall, PhD
Organizational Affiliation
James B. Edwards College of Dental Medicine, Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina Pediatric Dental Clinic
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25225565
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.
Results Reference
background
PubMed Identifier
32075705
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.
Results Reference
background
PubMed Identifier
24731910
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.
Results Reference
background
PubMed Identifier
29663907
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.
Results Reference
background
PubMed Identifier
34283466
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/
Results Reference
background
PubMed Identifier
20332509
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.
Results Reference
background
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Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients?
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