An Effectiveness-Implementation Hybrid Study on the Use of Integrative Treatments for Perioperative Symptom Management.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Heart Rate Variability among Patients as assessed using time and frequency domain analysis of the heart rate.
研究概览
简要总结
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.
详细描述
There is an urgent need for effective, safe, and low-cost nonpharmacologic treatments for postoperative pain. This study aims to:
- assess the implementation of Music Medicine, Aromatherapy, and Battlefield Acupuncture among patients presenting for procedures at the Durham Veterans Affairs Medical Center; and,
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans Scheduled to undergo procedures at the Durham VA
排除标准
- •Hearing Loss
- •Procedures on the Ear
- •Risk of Bleeding
结局指标
主要结局
Heart Rate Variability among Patients as assessed using time and frequency domain analysis of the heart rate.
时间窗: Each day (over 8-hour periods, 7pm and 7am) from 5 days before surgery to postoperative day 5.
Heart rate variability represents the change in the time interval in milliseconds between successive heartbeats. It is a measure of input to the heart from both sympathetic and parasympathetic branches of the nervous system. Increased heart rate variability is the better outcome.
Fidelity of Treatment among Patients as assessed by a Fidelity Checklist
时间窗: Each day from Postoperative Day 0 to Day 5.
Fidelity, the degree to which an intervention was implemented as it was intended by the developers, will be measured using a fidelity instrument with three domains: adherence (adherence to each component of treatment, scale 1- 5), participant responsiveness (measured on the treatment expectation questionnaire scale 0-10), and dosage (scale 1-5). Higher scores are better. We will compare the average scores overall, and in each domain.
Implementation of Treatment among Providers as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures.
时间窗: On the day of surgery or within 1-day after.
The Acceptability of Intervention measure, Appropriateness of Intervention measure, and Feasibility of Intervention Measure will be used. Each of these three tools is a 4-item questionnaire that has been validated as a distinct and strong measure of implementation success. Scale values for each measure range from 1-5. The average of the three measures will be computed and compared. Higher scores represent better outcomes.
Fidelity of Treatment among Providers as assessed by a Fidelity Checklist
时间窗: On the day of surgery or within 1-day after.
Fidelity, the degree to which an intervention was implemented as it was intended by the developers, will be measured using a fidelity instrument with two domains: adherence (adherence to each component of treatment, scale 1- 5), and participant responsiveness (measured on the treatment expectation questionnaire scale 0-10). Higher scores are better. We will compare the average scores overall, and in each domain.
Implementation of Treatment among Patients as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures.
时间窗: Measurement will be at three points: within the 5 day period before surgery; on the day of Surgery; and on postoperative day 5.
The Acceptability of Intervention measure, Appropriateness of Intervention measure, and Feasibility of Intervention Measure will be used. Each of these three tools is a 4-item questionnaire that has been validated as a distinct and strong measure of implementation success. Scale values for each measure range from 1-5. The average of the three measures will be computed and compared at each time point. Higher scores represent better outcomes.
Pain and Pain Interference assessed among patients using the Defense veterans pain rating scale 2.0
时间窗: Each day from Postoperative Day 0 to Day 5.
The Defense and Veterans Pain Rating Scale 2.0 utilizes a numerical rating scale enhanced by functional word descriptors, color coding, and pictorial facial expressions matched to pain levels. Four supplemental questions measure how much pain: a) interferes with usual activity, b) interferes with sleep, c) affects mood and d) contributes to stress. The scale for each assessment ranges from 0-10. Three assessments will occur each day. The daily average values will be compared at each time point. Higher Scores represent worse outcomes.
次要结局
- Amount of Opioid medication received by patients assessed in average daily oral morphine equivalents.(Each day from Postoperative Day 0 to Day 5.)
- Quality of Recovery among patients as measured using the Quality-of-Recovery 40 tool.(Preoperative on the day of surgery, and each day from Postoperative Day 0 to Day 5.)