Virtual Reality During Pediatric Cast Removal
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: Virtual Reality (VR).
- Кому может быть актуально
- Состояния в реестре: Fractures, Bone. Базовые параметры: 4 лет — 12 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Randomized Control Trial of Virtual Reality to Reduce Anxiety During Pediatric Cast Removal
Обзор
This study is a randomized control trial of Virtual Reality during cast removal procedures at a pediatric tertiary care center.
Подробное описание
Cast removal is a common outpatient procedure and is a source of pain and anxiety for children. Children are often frightened by the appearance and the noise of the saw. Additionally, the saw blade can become warm, and this can be uncomfortable. Multiple methods have been used and studied to try to make this experience easier for children. These methods include: soft music, therapeutic play, and headphones. Virtual reality (VR) devices are now increasingly affordable and portable. VR could be a way to distract children from the appearance and sound of the procedure. VR has been used in other clinical settings to help patients with the anxiety associated with medical procedures. The investigators propose a randomized trial to assess the responses (e.g. questionnaires and monitors) of children to cast removal with VR versus the standard noise reduction headphones.
Вмешательства
- Устройство Virtual Reality (VR)
Participants in the experimental group will receive an AppliedVR virtual reality headset during their cast removal.
Первичные конечные точки
- Change from baseline heart rate during cast removal procedure [Срок оценки: Heart rate will be measured during the cast removal procedure. As this is a single visit study, heart rate will not be measured at any other time periods throughout the study.]
Вторичные конечные точки (8)
- Change in Parent Reported Wong-Baker FACES Pain Scale Rating [Срок оценки: The Wong-Baker FACES Pain Scale assessment will be collected 1 minute prior to and immediately after cast removal.This is a single visit study and the assessment will not be measured at any other time periods.]
- Change in Patient Reported Wong-Baker FACES Pain Scale Rating [Срок оценки: The Wong-Baker FACES Pain Scale assessment will be collected 1 minute prior to and immediately after cast removal.This is a single visit study and the assessment will not be measured at any other time periods.]
- Visual Analog Scale (VAS): Parental anxiety during cast removal [Срок оценки: The VAS anxiety assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.]
- Visual Analog Scale (VAS): Patient anxiety during cast removal [Срок оценки: The VAS anxiety assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.]
- Visual Analog Scale (VAS): Parental Satisfaction [Срок оценки: The VAS parental satisfaction assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.]
- Visual Analog Scale (VAS): Parental Assessment of Pleasantness [Срок оценки: The VAS parental satisfaction assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.]
- Visual Analog Scale (VAS): Parent Reported Worst Pain During Treatment [Срок оценки: The VAS parental worst pain assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.]
- Visual Analog Scale (VAS): Patient Reported Worst Pain During Treatment [Срок оценки: The VAS patient worst pain assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.]
Критерии участия
Критерии включения
- Sustained a fracture in their arm/leg
- No previous experience with a cast removal
- Must have at least one wrist free of immobilization (for heart rate monitor)
- Parents and patient are English speaking
Критерии исключения
- Patients with a history of epilepsy, ventricular shunt, motion sickness
- Patients with any history of cognitive, visual or hearing impairment
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- Gillette Children's Specialty Healthcare — Saint Paul
Публикации
- Naranje SM, Erali RA, Warner WC Jr, Sawyer JR, Kelly DM. Epidemiology of Pediatric Fractures Presenting to Emergency Departments in the United States. J Pediatr Orthop. 2016 Jun;36(4):e45-8. doi: 10.1097/BPO.0000000000000595. PMID 26177059
- Wiggins CE, Brown KD. Hearing protection and cast saw noise. J South Orthop Assoc. 1996 Spring;5(1):1-4. PMID 8673584
- Katz K, Fogelman R, Attias J, Baron E, Soudry M. Anxiety reaction in children during removal of their plaster cast with a saw. J Bone Joint Surg Br. 2001 Apr;83(3):388-90. doi: 10.1302/0301-620x.83b3.10487. PMID 11341425
- Post JM, Switzer KD, Brown DK, Meinzen-Derr J, Dively J, Dunkin BS, Mehlman CT. Cast saw noise does not reach occupational hazard levels. J Pediatr Orthop. 2013 Jul-Aug;33(5):580-4. doi: 10.1097/BPO.0b013e318288b5e4. PMID 23752160
- Liu RW, Mehta P, Fortuna S, Armstrong DG, Cooperman DR, Thompson GH, Gilmore A. A randomized prospective study of music therapy for reducing anxiety during cast room procedures. J Pediatr Orthop. 2007 Oct-Nov;27(7):831-3. doi: 10.1097/BPO.0b013e3181558a4e. PMID 17878794
- Wong CL, Ip WY, Kwok BMC, Choi KC, Ng BKW, Chan CWH. Effects of therapeutic play on children undergoing cast-removal procedures: a randomised controlled trial. BMJ Open. 2018 Jul 5;8(7):e021071. doi: 10.1136/bmjopen-2017-021071. PMID 29980545
- Carmichael KD, Westmoreland J. Effectiveness of ear protection in reducing anxiety during cast removal in children. Am J Orthop (Belle Mead NJ). 2005 Jan;34(1):43-6. PMID 15707139
- Mahan ST, Harris MS, Lierhaus AM, Miller PE, DiFazio RL. Noise Reduction to Reduce Patient Anxiety During Cast Removal: Can We Decrease Patient Anxiety With Cast Removal by Wearing Noise Reduction Headphones During Cast Saw Use? Orthop Nurs. 2017 Jul/Aug;36(4):271-278. doi: 10.1097/NOR.0000000000000365. PMID 28737634
Идентификаторы
NCT: NCT03903510 · STUDY00005315