The Effect of Manual Acupuncture and Standard Therapy on Anxiety and Quality of Life Scores in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- Hamilton anxiety rating scale (HAM-A) score
研究概览
简要总结
The goal of this clinical trial is to prove that the combination of acupuncture therapy and standard therapy is more effective in reducing anxiety and improving the quality of life of cancer patients. The main questions it aims to answer are:
- Can the combination of manual acupuncture and standard therapy reduce anxiety based on Hamilton Anxiety Rating Scale (HAM-A) scores in cancer patients compared to the sham acupuncture and standard therapy group?
- Can the combination of manual acupuncture and standard therapy improve the quality of life of cancer patients based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ C30) compared to the sham acupuncture and standard therapy group?
Participants will:
Get manual acupuncture therapy and also standard therapy, such as oral Benzodiazepin and supportive psychotherapy or sham acupuncture therapy and the standard therapy (Benzodiazepin and supportive psychotherapy) every day for 6 days.
Researchers will compare the changes of anxiety scores and quality of life between cancer patients who received manual acupuncture therapy and standard therapy, and cancer patients who received sham acupuncture and standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants, and outcome assessors will be blinded to group allocation
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-59 years.
- •Diagnosed with cancer in the last 6 months
- •Experiencing moderate to severe anxiety (assessed by HAM-A Score > 14)
- •Willing to participate in this study until completion and sign an informed consent.
排除标准
- •Cancer patients with unstable hemodynamics
- •Cancer patients with brain metastases
- •Patients who have been diagnosed with anxiety disorders and have received pharmacological therapy from psychiatrists before.
- •Patients who have contraindications to manual acupuncture (there are wounds or infections at the point to be punctured, patients are allergic to stainless steel, patients are phobic of needles)
- •Patients who are uncooperative and do not allow acupuncture therapy (patients who are restless, angry)
- •Patients with poor liver function (SGOT (Serum Glutamic Oxaloacetic Transaminase) /SGPT (serum glutamate pyruvate transaminase)values increase 2-3 times the normal value)
- •Patients with blood clotting disorders (platelets <50,000, INR (International Normalized Ratio) > 2)
- •Patients with neutropenia (Absolute neutrophil count <1000)
- •Patients with overt DIC (disseminated intravascular coagulation) and acute venous or arterial thrombosis
研究组 & 干预措施
Intervention Group
The manual acupuncture and standard therapy
干预措施: Manual acupuncture and standard therapy (Procedure)
Control Group
The sham acupuncture and standard therapy
干预措施: Sham acupuncture and standard therapy (Procedure)
结局指标
主要结局
Hamilton anxiety rating scale (HAM-A) score
时间窗: 6 days
One tool to measure the degree of anxiety symptoms is a questionnaire. Scores range from 0-56.
次要结局
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ C30) score(6 days)
研究者
Deity Indrayati Nugraha
Medical doctor
Indonesia University