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Набор скоро начнётся NCT07391891

Musical Mindfulness for Pain in the ED Waiting Room

Без фазы С лечением Music Therapy for Pain and Sedation Neck Pain Musculoskeletal Back Pain

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: Music intervention.
Кому может быть актуально
Состояния в реестре: Music Therapy for Pain and Sedation, Neck Pain Musculoskeletal, Back Pain. Базовые параметры: 18 лет — 75 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 →
Официальное название

Use of Music Mindfulness for Pain Management in the ED Waiting Room

Обзор

Studies have shown that 60-70% of patients in the Emergency Department (ED) experience pain. With pain being such a broad issue in the ED, the ED is expected to deliver safe and effective treatment of pain. However, with the current ongoing opioid epidemic, it is important to consider other methods, both pharmacologic and nonpharmacologic, of pain reduction. Jazz music specifically has been demonstrated to have therapeutic effects on pain that can be used to lower the quantity of opioids administered to patients. Non-pharmacological interventions in the emergency department for pain typically consist of splinting an injury, applying heat or cold, or various distractions following initial and sequential pain assessment. Pharmacological interventions for pain in the Emergency Department involve the administration of acetaminophen, muscle relaxers, topical anesthetics, opioids, to name a few. In the emergency department (ED), providers are increasingly hesitant to prescribe opioids over the past decade due to the current opioid epidemic, in which there is an increasing proportion of people that develop an addiction to opioids, including those that are prescribed to them for pain management.. While emergency medicine providers' decrease in opioid prescriptions pertains to their implementation of opioid-prescribing policies, little evidence has been found demonstrating a direct link in these policies to decreases in substance misuse. Consequently, providers find themselves needing to become ingenious in their approach to pain in patients through the integration of pharmacologic and non-pharmacologic mediums of analgesia. A recent randomized controlled trial (RCT) from Brigham and Women's Hospital in Boston sought to identify the qualitative responses from patients in the ED following the arbitrary distribution of either supervised or unsupervised music therapy over a time period of 4 hours. The initial results found that, generally speaking, music therapy may lower reported pain and anxiety scores. Furthermore, stronger results were identified in case subjects with higher initial reports of pain via a pain catastrophizing scale, implying that a higher baseline of pain results in more relief from music therapy. One shortcoming in the article is the lack of analysis with reported results and the biopsychosocial model of pain. Heavy emphasis is placed on the psychological and social components of pain in the Brigham and Women's article through the implementation of the Pain Catastrophizing Scale and Brief Pain Inventory scoring done during the RCT, but no focus on linked biological changes in the subjects through the music therapy intervention. The purpose of this study is to (i.) assess the effect of a video training about musical pain management followed by a 15-minute music listening intervention on self-reported pain scores in ED patients with neck and back pain. The investigators also aim to (ii.) evaluate patient satisfaction and emotional response following the intervention. Opioid medications are commonly used to reduce substantial pain, and music therapy has been found to reduce associated pain and anxiety in patients, then the use of music therapy could be an aid in medicine to reduce opioid intake. The investigators hypothesize that the usage of a training on musical pain management combined with a specified jazz musical intervention will produce a significantly lower measured pain score in comparison to a video on mindful pain management followed by the patient's choice of activities.

Подробное описание

1. Patients presenting to the Emergency Department with neck or back pain in the waiting room are approached for the study. 2. Researchers confirm patients' interest. Consent patient by having them sign the HIPAA Waiver and Informed Consent Form. 3. Obtain an initial pain measurement of the subject prior to randomization. Additionally, obtain demographic information about the subject 4. Randomize subjects into either the intervention group (mindful music listening video followed by jazz music playlist administration) or the control group (pain management video followed by video or music of participants choice administered) using a simple randomizer, such as the Sealed Envelope application. 5. Deliver musical pain management video (intervention group) OR allow for the current standard of care with pain management presentation video for 15 minutes (control group). 6. Deliver musical intervention to subjects in the intervention group for 15 minutes, or allow subjects in the control group to listen to music or video of their choice for 15 minutes. 7. Following the 15-minute music intervention or 15-minute control, obtain a new pain measurement 8. Follow up after 30 minutes after the music intervention finished and acquire pain measurements again 9. Follow up 1 hour after the music intervention finished and acquire pain measurements again 10. Administer brief survey to patient asking if they enjoyed or disliked the experience of the study and if they are likely or unlikely to participate again.

Вмешательства

  • Поведенческое Music intervention
    Participant's will be taught how to mindfully listen to jazz to reduce pain

Первичные конечные точки

  • Pain score using Pain, Enjoyment of Life and General Activity Scale (PEG) [Срок оценки: Day 1]
  • Pain Intensity [Срок оценки: Day 1]
Вторичные конечные точки (1)
  • Satisfaction with Study [Срок оценки: 1 hour and 30 minutes after baseline]

Критерии участия

Критерии включения

  • \- Age >= 18 years old and <=75 years old
  • Patient presents with neck or back pain

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of California, Irvine, Emergency Department — Orange

Публикации

  • Pourmand A, Jasani G, Shay C, Mazer-Amirshahi M. The Evolving Landscape of Acute Pain Management in the Era of the Opioid Crisis. Curr Pain Headache Rep. 2018 Aug 27;22(11):73. doi: 10.1007/s11916-018-0728-y. PMID 30151792
  • Young SD, Kim J, Hanley A. Mindful Jazz and Preferred Music Interventions Reduce Pain Among Patients With Chronic Pain and Anxiety: A Pilot Randomized Controlled Trial. Cureus. 2025 Mar 12;17(3):e80485. doi: 10.7759/cureus.80485. eCollection 2025 Mar. PMID 40225443
  • Chanana L, Jegaraj MA, Kalyaniwala K, Yadav B, Abilash K. Clinical profile of non-traumatic acute abdominal pain presenting to an adult emergency department. J Family Med Prim Care. 2015 Jul-Sep;4(3):422-5. doi: 10.4103/2249-4863.161344. PMID 26288785
  • Chai PR, Schwartz E, Hasdianda MA, Azizoddin DR, Kikut A, Jambaulikar GD, Edwards RR, Boyer EW, Schreiber KL. A Brief Music App to Address Pain in the Emergency Department: Prospective Study. J Med Internet Res. 2020 May 20;22(5):e18537. doi: 10.2196/18537. PMID 32432550

Идентификаторы

NCT: NCT07391891 · STUDY00000311

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗