Animal Assisted Therapy in Pediatric Dentistry

Официальное название

Animal Assisted Therapy's Effects on Young Dental Patients

Обзор

A prospective randomized trial measuring physiologic biometrics and perceptions of stress during a pediatric dental exam, cleaning, and simulated radiographs with or without a therapy dog present.

Подробное описание

Patients will be consented, enrolled, and randomly assigned to a control group (no dog) or to an experimental group with dog present only before their dental visit for 3 minutes (+ Short AAT) or to an experimental group with dog present throughout their entire visit (+ Long AAT). Control (no dog) patients will have an active control where they color for 3 minutes before their dental exam, cleaning, and simulated radiographs, without a dog present. Biometric data will be collected with a small wireless wrist device (Shimmer 3) which measures heart rate and sweat response (skin galvanic response). Salivary samples will be taken before and after the dental visit to measure salivary cortisol and amylase, as a metric of physiological stress. Finally, a video feed of body movements during the dental visit will be collected for observational coding. Pre-visit and post-visit surveys will be given to all the patients on their experiences regarding pain, anxiety, and perceptions of the dental experience.

Вмешательства

• Поведенческое +Short AAT
  Interaction with therapy dog prior to dental exam, cleaning, and simulated radiographs.
• Поведенческое +Long AAT
  Interaction with therapy dog throughout dental exam, cleaning, and simulated radiographs.
• Поведенческое Active control; NO dog
  Color dog picture for 3 minutes prior to dental exam, cleaning, and simulated radiographs.

Первичные конечные точки

• Mean Heart Rate during Dental Exam [Срок оценки: During dental exam, approximately 2- 5 minutes.]
• Mean Heart Rate during Dental Cleaning [Срок оценки: During dental cleaning, approximately 2- 5 minutes.]
• Mean Heart Rate during Dental Radiograph Simulation [Срок оценки: During dental radiograph simulation, approximately 2- 5 minutes.]
• Salivary Cortisol during Dental Exam [Срок оценки: During dental exam, approximately 1-2 minutes.]
• Salivary Cortisol during Dental Cleaning [Срок оценки: During dental cleaning, approximately 1-2 minutes.]
• Salivary Cortisol during Dental Radiograph Simulation [Срок оценки: During dental radiograph simulation, approximately 1-2 minutes.]
• Salivary Amylase during Dental Exam [Срок оценки: During dental exam, approximately 1-2 minutes.]
• Salivary Amylase during Dental Cleaning [Срок оценки: During dental cleaning, approximately 1-2 minutes.]
• Salivary Amylase during Dental Radiograph Simulation [Срок оценки: During dental radiograph simulation, approximately 1-2 minutes.]

Критерии участия

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

• 4-8 years of age
• English speaking
• Qualifies for a dental exam and prophylaxis (cleaning) by having not received a dental prophylaxis or oral exam in the past 3 months
• Stable physical health, decided at the discretion of the study coordinator and PI
• Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based on research site personnel's assessment
• Evidence of a personally signed and dated informed assent form from the child and legal guardian's consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial and all of their questions have been answered

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

• Patients <4yo and >8yo
• Non-English speakers
• Patients unwilling to assent/participate or parental/guardian consent was not given
• Self-report or parental report of patient suffering current dental pain
• Known allergies or significant adverse reactions following exposure to dogs or the use of oral hygiene products (toothpastes, mouth rinses), and all ingredients in prophy paste
• Children who are afraid of dogs or had a prior negative experience with dogs as reported by the parent or child
• Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this trial
• Developmental/cognitive disability such that patient cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• General & Oral Health Center — Chapel Hill

Публикации

• Kapov G, Linton K, Gatewood C, Liu C, Strauman T, Hodges E, Graves C, Sawicki C, Wu D, Divaris K, Jacox LA. Effects of animal-assisted therapy on dental anxiety, behavior, and perceptions in young pediatric patients: a blinded randomized controlled trial. Trials. 2025 Aug 7;26(1):279. doi: 10.1186/s13063-025-08970-z. PMID 40775655

Идентификаторы

NCT: NCT05464888 · 22-1454 · UL1TR002489 · K08DE030235 · R03DE032768

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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