The Effect of Press Needle Acupuncture on Pain Reduction and Quality of Life Improvement in Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS) for Pain
研究概览
简要总结
The purpose of this clinical trial is to evaluate the effect of press needle acupuncture on pain management and quality of life improvement in patients with lung cancer.
The main question this study aims to answer is:
Does press needle acupuncture, when combined with standard therapy, provide better pain relief and quality of life improvement in lung cancer patients compared to standard therapy alone?
Researchers will compare press needle acupuncture to sham acupuncture to determine whether press needle acupuncture is more effective in reducing pain and improving quality of life.
Participants will:
Receive either press needle acupuncture or sham press needle acupuncture for 7 days
Visit the clinic once a week for examination and evaluation
Record improvements in pain intensity in a pain diary and assess quality of life using a quality of life questionnaire
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
the participants and the outcome assessors will be blinded to group allocation
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
- •Patients with a confirmed diagnosis of lung cancer through histopathology or radiology.
- •Lung cancer patients aged over 18 years.
- •Stage III-IV lung cancer patients receiving therapy at Dr. Cipto Mangunkusumo National General Hospital (RSUPN) and Tangerang District General Hospital (RSUD Kabupaten Tangerang).
- •Patients with a VAS score >10 mm for baseline pain and >40 mm during breakthrough pain.
- •Willing to participate in the study until completion by signing the informed consent form.
排除标准
- •Lung cancer patients with deteriorating general condition.
- •Presence of wounds or infections at the press needle insertion site.
- •History of allergy to stainless steel materials.
- •Patients with blood clotting disorders: platelet count <50,000/μL, ANC <1000/mm³, or patients undergoing anticoagulant therapy with INR >2.142.
研究组 & 干预措施
Intervention Group
The press needle acupuncture and standart therapy
干预措施: Press Needle Acupuncture and standart therapy (Device)
Control Group
The sham press needle acupuncture and standart therapy
干预措施: Press Needle Acupuncture and standart therapy (Device)
结局指标
主要结局
Visual Analogue Scale (VAS) for Pain
时间窗: Before therapy, Day 1, Day 3, Day 7, and Day 14
Pain intensity will be measured using the Visual Analogue Scale (VAS), which consists of a horizontal or vertical line 10 cm (100 mm) in length, representing a continuum of pain intensity from: 0 = No pain at all 10 = Worst imaginable pain
次要结局
- Functional Assessment of Cancer Therapy - Lung (FACT-L)(Before therapy, Day 7, and Day 14)
研究者
Yuanti Yunus Konda
MD
Indonesia University