A Pilot Randomized Controlled Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain, Nausea, Anxiety and Ability to Cope.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Patients Eligible Compared to the Number Approached and Enrolled
研究概览
简要总结
The purpose of the study is to compare the effect of acupuncture to the standard of care (control group) on pain, nausea, anxiety, ability to cope, costs and length of hospital stay in post-mastectomy patients at Abbott Northwestern Hospital.
详细描述
About 40 subjects will be participating in this study. Following qualification for the study, participants will be randomly assigned by chance to receive either acupuncture or to receive the standard of care without an integrative medicine session.
- One group will receive acupuncture after surgery. Acupuncture involves inserting thin, sterile needles at certain points on your body.
- The other group will receive the standard of care without an acupuncture session.
Before surgery participants will complete a demographics questionnaire. After surgery, participants will be visited in their hospital room by either an acupuncturist or another member of the research team. For those assigned to the acupuncture group, participants will receive up to two sessions of acupuncture, at least twelve hours apart. For those assigned to the control group, a research team member will visit the participant in their room up to two times, at least twelve hours apart. During those visits, participants will be asked about pain, nausea, anxiety, and ability to cope at the beginning and end of each treatment or visit.
Additional information will be gathered from participants hospital charts, such as the type of surgery that was performed, length of hospital stay, and the costs associated with the hospital stay.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Undergoing mastectomy surgery
排除标准
- •Non-English speaking
- •Also undergoing an oophorectomy, TRAM or Latissimus flap surgery
研究组 & 干预措施
Acupuncture
Two sessions of acupuncture, at least twelve hours apart, post-mastectomy.
干预措施: Acupuncture (Other)
Standard of Care
Standard of care post-mastectomy.
结局指标
主要结局
Number of Patients Eligible Compared to the Number Approached and Enrolled
时间窗: One year
Feasibility will be measured by the number of patients eligible for enrollment, the number approached, the number consented, and the final sample with completed data. The study population will be described in terms of demographics and background characteristics collected on the enrollment questionnaire.
次要结局
- Change in Pain Post Intervention(Participants will be followed on post operations day 1 and 2 of their hospital stay)
- Change in Anxiety Post Intervention(Participants will be followed on post operations day 1 and 2 of their hospital stay)
- Change in Nausea Post Intervention(Participants will be followed on post operations day 1 and 2 of their hospital stay)
- Change in Ability to Cope Post Intervention(Participants will be followed on post operations day 1 and 2 of their hospital stay)