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Набор скоро начнётся NCT06333938

Veterans Enhanced Recovery Using Integrative Treatments Around Surgery

Фаза IV С лечением Anesthesia Surgery Knee Arthropathy

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: Nonpharmacologic Treatment, Standard Care.
Кому может быть актуально
Состояния в реестре: Anesthesia, Surgery, Knee Arthropathy. 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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Официальное название

An Effectiveness-Implementation Hybrid Study on the Use of Integrative Treatments for Perioperative Symptom Management.

Обзор

The study aims to assess the implementation and effectiveness of Integrative Treatments - Music Medicine, Aromatherapy, and Battlefield Acupuncture - in the management of perioperative pain and anxiety, and in the reduction of related pharmacologic treatments.

Подробное описание

There is an urgent need for effective, safe, and low-cost nonpharmacologic treatments for postoperative pain. This study aims to:

1. assess the implementation of Music Medicine, Aromatherapy, and Battlefield Acupuncture among patients presenting for procedures at the Durham Veterans Affairs Medical Center; and, 2. compare the effectiveness of these treatments, alone and in combination, versus standard clinical practice not involving any of these treatments.

Patients from the Durham Veterans Affairs Medical Center (Durham VAMC) scheduled to undergo procedures will be eligible to participate in this study. A sample of 400 veterans will be studied. We will offer treatments versus no treatment on alternate months. Recruitment will end when 200 patients have received at least one of these treatments, and 200 patients have received no treatment.

Вмешательства

  • Другое Nonpharmacologic Treatment
    At least one three nonpharmacologic treatments (Music Medicine, Aromatherapy, Battlefield Acupuncture) will be delivered. Music Medicine is the delivery of personal music players to listen to patient-preferred music before, during, or after surgical or non-surgical procedures. Aromatherapy is the delivery of personally-preferred AromaTabs before, during, or after surgical or non-surgical procedures. Battlefield Acupuncture is the delivery of Auricular Acutherapy by trained providers using acupun
  • Другое Standard Care
    Patients will receive standard clinical care without the addition of Music Medicine, Aromatherapy, or Battlefield Acupuncture

Первичные конечные точки

  • Pain and Pain Interference assessed among patients using the Defense veterans pain rating scale 2.0 [Срок оценки: Each day from Postoperative Day 0 to Day 5.]
  • Heart Rate Variability among Patients as assessed using time and frequency domain analysis of the heart rate. [Срок оценки: Each day (over 8-hour periods, 7pm and 7am) from 5 days before surgery to postoperative day 5.]
  • Implementation of Treatment among Patients as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures. [Срок оценки: Measurement will be at three points: within the 5 day period before surgery; on the day of Surgery; and on postoperative day 5.]
  • Fidelity of Treatment among Patients as assessed by a Fidelity Checklist [Срок оценки: Each day from Postoperative Day 0 to Day 5.]
  • Implementation of Treatment among Providers as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures. [Срок оценки: On the day of surgery or within 1-day after.]
  • Fidelity of Treatment among Providers as assessed by a Fidelity Checklist [Срок оценки: On the day of surgery or within 1-day after.]
Вторичные конечные точки (2)
  • Amount of Opioid medication received by patients assessed in average daily oral morphine equivalents. [Срок оценки: Each day from Postoperative Day 0 to Day 5.]
  • Quality of Recovery among patients as measured using the Quality-of-Recovery 40 tool. [Срок оценки: Preoperative on the day of surgery, and each day from Postoperative Day 0 to Day 5.]

Критерии участия

Критерии включения

  • Veterans Scheduled to undergo procedures at the Durham VA

Критерии исключения

  • Hearing Loss
  • Procedures on the Ear
  • Risk of Bleeding
  • Anosmia

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Durham Veterans Affairs Medical Center — Durham

Идентификаторы

NCT: NCT06333938 · 01968

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗