Animal Assisted Therapy in Dentistry

NCT ID: NCT04708028

Last Updated: 2024-08-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-26

Study Completion Date

2024-03-04

Brief Summary

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A cross-sectional prospective study measuring physiologic biometrics and perceptions of stress during a dental procedure with or without a therapy dog present.

Detailed Description

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Patients will be consented, enrolled, and 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 Shimmer or Polar device.

Conditions

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Anxiety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

No exposure to the therapy dog.

Group Type NO_INTERVENTION

No interventions assigned to this group

Dog Therapy

Introduced to a therapy dog and allowed to pet the dog for up to 2 minutes (timed) prior to the dental procedure.

Group Type EXPERIMENTAL

Dog Therapy

Intervention Type OTHER

The intervention is a therapy dog interaction (e.g. petting) for up to 2 minutes before their appointment and first interaction with the doctor. The subject can pet the dog for as long as they like up until the 2 minute mark.

Interventions

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Dog Therapy

The intervention is a therapy dog interaction (e.g. petting) for up to 2 minutes before their appointment and first interaction with the doctor. The subject can pet the dog for as long as they like up until the 2 minute mark.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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) and/or extraction(s)
* History of moderate dental anxiety with a Frankl score of 2-3 based on Epic chart review

Exclusion Criteria

* 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) or 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).
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura A Jacox, DMD, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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General & Oral Health Center

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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Massouda J, Ghaltakhchyan N, Judd J, Bocklage C, Selden R, TumSuden O, Nanney E, Lee J, Ginnis J, Strauman T, Sawicki C, Hodges EA, Graves C, Divaris K, Jacox L. Evaluating effects of animal-assisted therapy on pediatric dental care patients: A pilot clinical trial. J Am Dent Assoc. 2025 Jun;156(6):447-457.e14. doi: 10.1016/j.adaj.2025.03.006.

Reference Type DERIVED
PMID: 40467121 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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19-1911

Identifier Type: -

Identifier Source: org_study_id

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