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Идёт набор NCT07187245

Feasibility of the Reality PAWS Program for Children in Isolation

Без фазы С лечением Inpatient Pediatric Care Isolation Feasibility Studies

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Reality PAWS Program via Meta Quest 3 VR.
Кому может быть актуально
Состояния в реестре: Inpatient Pediatric Care, Isolation, Feasibility Studies. Базовые параметры: 8 лет — 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Reality PAWS: Examining the Feasibility of a Mixed Reality Dog Visitation Program for Hospitalized Children in Isolation

Обзор

The goal of this clinical trial is to learn if a mixed reality program, Reality PAWS, delivered on a Meta Quest 3 VR headset, is a feasible intervention for pediatric patients in isolation. It will also evaluate the safety of the program and its effect on pain, anxiety, and loneliness. The main questions the study aims to answer are: What is the feasibility of utilizing Reality PAWS MR as a substitute for in-person dog therapy for children under isolation precautions? Are patients compliant with using Reality PAWS MR? What are the interventional outcomes of Reality PAWS MR? Participants will: Wear a Meta Quest 3 VR headset with the Reality PAWS program. Interact with the program. Answer surveys regarding demographics, anxiety, pain, loneliness, sickness, perceived exertion, and immersion in the program.

Вмешательства

  • Устройство Reality PAWS Program via Meta Quest 3 VR
    Reality PAWS is a mixed reality (MR) game that allows patients to interact with a virtual dog. It was developed at Children's Hospital Colorado to serve patients under isolation precautions who are unable to be visited by a facility dog in person. Patients can interact with the game through features such as walking the dog, providing commands, outfitting the dog, giving treats, playing fetch, petting the dog, and playing with others.

Первичные конечные точки

  • Recruitment Feasibility [Срок оценки: Through study completion, an average of 6 months.]
  • Intervention Feasibility - Time Spent Using MR [Срок оценки: From baseline until study session completion, approximately 30 minutes.]
  • Intervention Feasibility - Software [Срок оценки: From baseline until study session completion, approximately 30 minutes.]
  • Electonic Case Report Qualitative Feedback and Observations [Срок оценки: From baseline until study session completion, approximately 30 minutes.]
  • Measurement Feasibility [Срок оценки: Through study completion, an average of six months.]
  • Child Simulator Sickness Questionnaire [Срок оценки: Completed at baseline and again at study session completion, approximately 30 minutes after completing the study intervention MR.]
  • Borg Rating of Perceived Exertion [Срок оценки: At intervention session completion, approximately 30 minutes after starting the MR intervention.]
  • Gold-Rizzo Immersion and Presence [Срок оценки: Completed at study session completion, approximately 30 minutes after completing the MR intervention.]
  • Amount of adverse or serious adverse events [Срок оценки: Until study completion, about 6 months.]
Вторичные конечные точки (5)
  • Faces Anxiety Scale [Срок оценки: Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.]
  • Faces Pain Scale [Срок оценки: Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.]
  • Childhood Anxiety Sensitivity Index [Срок оценки: Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.]
  • Loneliness Visual Analog Scale [Срок оценки: Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.]
  • Multidimensional State Boredom Scale - Short Form [Срок оценки: Collected at baseline, before the intervention, and again after intervention, on average, 30 minutes after.]

Критерии участия

Критерии включения

  • Children 8 to 21 years old admitted to Children's Hospital Colorado or Children's Hospital Los Angeles
  • Children who are English-speaking (legal guardian may be English-speaking or Spanish-speaking)
  • Children within the normal range of development will be recruited for this study.

Критерии исключения

  • Traumatic brain injury, neurological disorders, neurodevelopmental issues, or other neurological disorders and comorbidities that may confound study outcomes and administration of the study protocol and metrics (e.g., visual field disturbances, frequent nausea/ vomiting, not medically stable, intellectual disability)
  • Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
  • Children with a history of seizure disorder
  • Children currently sick with flu-like symptoms or experiencing a headache or earache
  • Children with known or suspected motion sickness
  • Children with cochlear implants or pace makers

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 2 центра
  • Children's Hospital Los Angeles — Los Angeles
  • Children's Hospital Colorado Anschutz Medical Campus — Aurora

Идентификаторы

NCT: NCT07187245 · 25-1732

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗