The Efficacy of Acupuncture as a Complementary Treatment for Pain and Anxiety After Breast Cancer Surgery: Pragmatic Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Post-intervention pain at 12 hours after surgery
研究概览
简要总结
Background: Breast cancer is one of the most prevalent cancers worldwide. Fortunately, survival has improved in recent years thanks to its early detection and curative treatments such as mastectomy. However, this medical procedure is associated with a range of unwanted effects such as postoperative pain and anxiety. Some studies have reported that acupuncture could be an effective treatment to control these types of symptoms, although only few studies have been conducted on women undergoing mastectomy.
Methods: This is a pragmatic randomized controlled trial with blind assessors. The study will be conducted in the Breast Unit of Hospital Universitario Sagrado Corazon of Barcelona (Spain). A sample of 40 women will be recruited and randomized to receive acupuncture treatment in addition to standard care procedures, or standard care procedures alone. The main outcome, pain, will be assessed after the surgical intervention and 4, 10 and 30 days later using the numerical rating scale. Secondary outcomes include anxiety, use of analgesics, nausea, adverse effects, and surgical complications.
Discussion: Acupuncture is a low-cost non-pharmacological strategy. This study will help to clarify its possible role in controlling post-mastectomy adverse effects.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of breast cancer
- •Primary breast cancer patient
- •Candidate for breast cancer surgery (mastectomy)
- •Aged between 20 and 70 years old
- •Consenting to participate in the study and signing the informed consent form.
排除标准
- •Have a previous history of breast cancer
- •Have a previous diagnosis of a severe psychiatric disorder
- •Present risk factors associated with breast cancer
- •Do not speak Spanish or Catalan
- •Are currently participating in another trial.
结局指标
主要结局
Post-intervention pain at 12 hours after surgery
时间窗: 12 hours after surgery (before the acupuncture treatment)
Pain will be evaluated using the numerical rating scale (NRS). This measure uses a scale of 0 to 10 in which the higher values represent the most severe pain.
Analgesic compsumption at home
时间窗: From discharge until day 15 after surgery.
Amount of analgesic medication administered (ex: mg)
Analgesic compsumption during hospital stay
时间窗: During the hospital stay
Amount of analgesic medication administered (ex: mg)
Post-intervention pain at first out-patient visit
时间窗: In the first out-patient visit between 10 and 12 days after the intervention (evaluated before the acupuncture session)
Pain will be evaluated using the numerical rating scale (NRS). This measure uses a scale of 0 to 10 in which the higher values represent the most severe pain.
Post-intervention pain at 48 hours after surgery
时间窗: 48 hours after surgery (after the acupuncture treatment)
Pain will be evaluated using the numerical rating scale (NRS). This measure uses a scale of 0 to 10 in which the higher values represent the most severe pain.
次要结局
- Post-operative complications(Up to one month.)
- Postoperative nausea after surgery(At 12 hours after surgery)
- Postoperative nausea at 24-48 hours(At 24-48 hours after surgery)
- Acupuncture adverse events(Up to one month.)
- Anxiety at 12 hours(Evaluations will be made 12 hours after the intervention)
- Anxiety at 48 hours(Evaluations will be made 48 hours after the intervention)
- Anxiety at one month(Evaluations will be made at one month after surgery.)
- Anxiety at first visit(Evaluations will be made at first visit, between 10 and 12 days after the intervention.)