Идёт набор NCT07070401
The Use of AR / VR in Patients Presenting to the ED With Renal Colic
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: Commercial AR/VR Headset with Calming App, Pharmacologic Standard of Care Alone.
- Кому может быть актуально
- Состояния в реестре: Renal Colic, Kidney Stones, Urolithiasis, Hypocitraturia. Базовые параметры: от 18 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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Обзор
Utilization of VR / AR Calming as an adjunct to pharmacologic pain management for Renal Colic in Emergency Department Patients
Подробное описание
This study will randomize ED patients presenting for presumed renal colic to either standard pharmacologic pain management alone, or pharmacologic management plus use of an adjunct Virtual / Augmented reality calming application using an off-the-shelf VR/AR Headset.
Вмешательства
- Устройство Commercial AR/VR Headset with Calming App
Commercial AR/VR Headset with Calming App in addition to Pharmacologic Standard of Care - Другое Pharmacologic Standard of Care Alone
Pharmacologic Standard of Care Alone
Первичные конечные точки
- 60 Minute Pain Level [Срок оценки: 60 minutes]
Вторичные конечные точки (7)
- 30 Minute Pain Level [Срок оценки: 30 minutes]
- 30 Minute Heart Rate [Срок оценки: 30 minutes]
- 30 Minute Blood Pressure [Срок оценки: 30 minutes]
- 60 Minute Heart Rate [Срок оценки: 60 Minutes]
- 60 Minute Blood Pressure [Срок оценки: 60 minutes]
- Rescue Analgesia Use [Срок оценки: 4 hours]
- Rescue Intervention [Срок оценки: 24 Hours]
Критерии участия
Критерии включения
- Patient self-reported history of nephrolithiasis
- Subjective history suggesting that current presentation is similar to past presentations of nephrolithiasis (character, quality, location, intensity of pain; previous surgical intervention or lithotripsy)
- Patients with self-reported moderate to severe pain on the visual pain scale determined as greater than 5/10
- Normal vital signs (afebrile)
- Agreeable to informed consent as dictated by IRB and local practice
- No contraindications to standard therapy (ie fluids, NSAIDs, opioids, etc.)
- Compliance with the virtual reality treatment
- Keeps the headset on for the duration of the experience
- Understands the instructions
Критерии исключения
- Age < 18 years
- Pregnant
- Individuals with chronic pain conditions such as fibromyalgia (chronic pain may confound results, as patients may have higher than baseline pain levels affecting their response to medications)
- Individuals with severe anxiety or claustrophobia
- Individuals with severe motion sickness or previous episodes of motion sickness due to VR (those who may not react well to the VR experience)
- Individuals with GFR<60 or previous documented diagnosis of CKD as they may not be suitable candidate for traditional analgesia
- Individuals with previous opioid dependence
- Requirement of immediate surgery (obstructing calculi with concomitant urinary tract infection)
- Patients with diagnoses meeting admission criteria (sepsis, MI)
- Audio/visual impairment (unable to appreciate stimuli provided by the headset)
- Patients administered opiates as the first line pain control medication will not be included in final data collection, as opioid administration may result in difficulty consenting and understanding the study protocol / design
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
- Лечение
Центры проведения
США · 1 центр
- Rutgers Robert Wood Johnson Barnabas Health Community Medical Center — Toms River
Публикации
- Weynants L, Chys B, D'hulst P, Merckx L, Van Besien J, Tailly T. Virtual reality for pain control during shock wave lithotripsy: a randomized controlled study. World J Urol. 2023 Feb;41(2):589-594. doi: 10.1007/s00345-023-04280-8. Epub 2023 Jan 21. PMID 36680576
- Pourmand A, Davis S, Marchak A, Whiteside T, Sikka N. Virtual Reality as a Clinical Tool for Pain Management. Curr Pain Headache Rep. 2018 Jun 15;22(8):53. doi: 10.1007/s11916-018-0708-2. PMID 29904806
- Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019. PMID 31308733
- Gottlieb M, Long B, Koyfman A. The evaluation and management of urolithiasis in the ED: A review of the literature. Am J Emerg Med. 2018 Apr;36(4):699-706. doi: 10.1016/j.ajem.2018.01.003. Epub 2018 Jan 5. PMID 29321112
- Holdgate A, Pollock T. Systematic review of the relative efficacy of non-steroidal anti-inflammatory drugs and opioids in the treatment of acute renal colic. BMJ. 2004 Jun 12;328(7453):1401. doi: 10.1136/bmj.38119.581991.55. Epub 2004 Jun 3. PMID 15178585
- Epidemiology of Nephrolithiasis. Course on Advances in Nephrology and Dialysis
- Worcester EM, Coe FL. Nephrolithiasis. Prim Care. 2008 Jun;35(2):369-91, vii. doi: 10.1016/j.pop.2008.01.005. PMID 18486720
Идентификаторы
NCT: NCT07070401 · 25-001