Pragmatic Randomized Controlled Trial of Adjunct Acupuncture vs Usual Care Among Hospitalized Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 2
- 主要终点
- Self-reported pain
研究概览
简要总结
Many hospitalized patients experience pain during their hospital stay, and less than half report adequate pain relief. Common treatments for pain include opioid medications, which have associated side effects and complications. Research has shown that acupuncture is effective for surgical, postoperative and cancer-related pain, nausea, and vomiting. More research is needed on the effectiveness of adding acupuncture to routine care for hospitalized patients. The objective of this study is to examine the effectiveness of acupuncture delivered in a "real-world" setting according to the principles of traditional Chinese medicine among hospitalized patients to manage pain and other symptoms. 250 hospitalized participants will be randomized in a 1 to 1 ratio to receive either 1) usual care or 2) usual care with acupuncture offered (125 in each group). The primary outcome measure will be change in daily pain intensity. Data on other symptoms, such as nausea, vomiting, anxiety, and depression, as well as functionality and quality of life will be collected in person, on a web-based survey, or via telephone follow-up. The aims of the study are to examine the effectiveness of acupuncture to manage pain and other symptoms among hospitalized patients; to evaluate the impact of acupuncture on patient satisfaction among hospitalized patients; and to estimate costs and cost-effectiveness of acupuncture among a subset of hospitalized patients.
The investigators hypothesize that compared to hospitalized patients receiving usual care alone, hospitalized patients receiving acupuncture will have:
- decreased pain severity
- higher patient satisfaction
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •English or Spanish speaking
- •Admitted to Mt Zion Hospital for a minimum anticipated length of stay for at least 4 days
- •Aged 18 or older
- •In a ward included in the roll out of the Osher Center's acupuncture program at Mt Zion
排除标准
- •Unstable medical condition (e.g., severe pulmonary disease, myocardial infarction, severe depression, patients in the intensive care unit)
- •Acupuncture contraindication (e.g., sepsis, endocarditis)
- •Inability to consent or complete surveys (e.g., cognitive or communication impairment)
结局指标
主要结局
Self-reported pain
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 6 days
Daily pain intensity will be measured on a 0-10 numeric rating scale. The APS Patient Outcome Questionnaire will also be administered each day to measure pain severity and relief; impact of pain on activity, sleep, and negative emotions; side effects of treatment; helpfulness of information about pain treatment; and ability to participate in pain treatment decisions.
次要结局
- Functionality and quality of life(Participants will be followed for the duration of hospital stay and for several days after hospital discharge, an expected total average of 9 days)
- Patient satisfaction(Participants will be followed for the duration of hospital stay and for several days after hospital discharge, an expected total average of 9 days)
- Self-reported anxiety and depression(Participants will be followed for the duration of hospital stay, an expected average of 6 days)
- Self-reported nausea and vomiting(Participants will be followed for the duration of hospital stay, an expected average of 6 days)
- Self-reported global well-being(Participants will be followed for the duration of hospital stay, an expected average of 6 days)
- Self-reported global rating of change(Participants will be followed for the duration of hospital stay, an expected average of 6 days)