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Animal Assisted Therapy in Dentistry (ATT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04708028
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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Brief Summary:
A cross-sectional prospective randomized study measuring physiologic biometrics and perceptions of stress during an orthodontic procedure with or without a therapy dog present.

Condition or disease
Anxiety

Detailed Description:
Patients will be consented, enrolled, and randomly assigned to a control group (no dog) or to an experimental group (dog). The patient assigned to the experimental group will be exposed to the therapy animal prior to the dental appointment. Pre-dental procedure and post- dental procedure surveys will be given to all the subjects asking the same questions. Biometric data will be collected by measuring heart rates of the patient/subject during the dental appointment with a Fitbit.
Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Animal Assisted Therapy's Effects on Orthodontic Patients
Actual Study Start Date : July 26, 2021
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Groups and Cohorts
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Group/Cohort
Control
No exposure to the therapy dog.
Dog Therapy
Introduced to a therapy dog and allowed to pet the dog for up to 2 minutes (timed) prior to the dental procedure.


Outcome Measures
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Primary Outcome Measures :
  1. Heart Rate [ Time Frame: During dental procedure, an approximate total of 90 minutes ]
    beats per minute during dental procedure

  2. Galvanic Skin Response [ Time Frame: During dental procedure, an approximate total of 90 minutes ]
    Galvanic Skin Response (GSR) unit (Shimmer, Boston, MA) which uses phasic conductance and an optical pulse sensing probe. The small portable wristband device attaches to three sensors that are placed on the fingers of the non-dominant hand using velcro straps. The device will be placed on each subject a the beginning of each session and removed at the end of each session.


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

120 participants total (60 no therapy dog exposure, 60 with therapy do exposure) recruited from UNC Graduate Pediatric Dental Clinic

1 quadrant of restorative dental procedures requiring a handpiece (could include multiple fillings, sealants and/or stainless-steel crowns) not requiring sedation (no nitrous, no pharmacological sedation) 7-17 years of age any gender or race/ethnicity moderate dental anxiety with a Frankl score of 2-3 No fear of dogs or dog allergies

Criteria

Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:

  • 7-17 years of age
  • Patient undergoing 1 quadrant restorative dental procedure requiring a handpiece (e.g. multiple fillings, sealants and/or stainless-steel crowns)
  • History of moderate dental anxiety with a Frankl score of 2-3 based on Epic chart review

Exclusion Criteria Subjects presenting with any of the following will not be included in the study:

  • Patients with developmental delay/special needs, Autism Spectrum Disorders (ASDs), craniofacial defects, chronic pain conditions, and/or dental syndromes
  • No history of dental anxiety
  • Moderate to severe allergy to dogs
  • Previous traumatic experience with a dog and/or self-reported fear of dogs
  • Patients who are not receiving dental care requiring a handpiece (for ex, prophylaxis only)
  • Patients with severe, documented xerostomia
  • Patients receiving sedation (pharmacological and conscious sedation), nitrous oxide, general anesthesia
  • Patients who will have physical restraints placed during the dental procedure
  • Patient scheduled to have sedation or general anesthesia
  • Severe acute or chronic medical or psychiatric condition(s) that would interfere with the interpretation of results, and in the judgement of the Investigator, would make the subject inappropriate for entry into the trial
  • Patient with developmental/cognitive disability that cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment.
  • Inability or unwillingness of individual and legal guardian/representative to give written informed assent (from child) and consent (from adult).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04708028


Contacts
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Contact: Laura A jacox, DMD, PhD, Ms 919-537-3424 ljacox@live.unc.edu
Contact: S.T. Phillips, BSDH 9195373422 sherrill_phillips@unc.edu

Locations
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United States, North Carolina
General & Oral Health Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: S.T. Phillips    919-537-3422    sherrill_phillips@unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Laura A Jacox, DMD, PhD, MS University of North Carolina, Chapel Hill
More Information
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04708028    
Other Study ID Numbers: 19-1911
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning following publication up to 1 year provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting Materials: Study Protocol
Time Frame: 1 month following publication up to 1 year
Access Criteria: Deidentified individual data that supports the results will be shared beginning following publication up to 1 year provided the investigator who proposes to use the data has approval from an IRB, IEC, or REB as applicable, and an executed data use/sharing agreement with UNC.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No