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Press Needle Acupuncture for Pain and Quality of Life in Lung Cancer Patients

Not Applicable
Not yet recruiting
Conditions
Lung Cancer Patients
Registration Number
NCT07112950
Lead Sponsor
Indonesia University
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
32
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Primary Outcome Measures
NameTimeMethod
Visual Analogue Scale (VAS) for PainBefore 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

Secondary Outcome Measures
NameTimeMethod
Functional Assessment of Cancer Therapy - Lung (FACT-L)Before therapy, Day 7, and Day 14

Quality of life will be assessed using the FACT-L questionnaire, consisting of 37 items rated on a 0-4 Likert scale:

0 = Not at all

1. = A little bit

2. = Somewhat

3. = Quite a bit

4. = Very much

Total scores range from 0 to 28 (higher scores indicate better quality of life).

Trial Locations

Locations (1)

Universitas Indonesia

🇮🇩

Jakarta Pusat, DKI Jakarta, Indonesia

Universitas Indonesia
🇮🇩Jakarta Pusat, DKI Jakarta, Indonesia
Yuanti Yunus Konda, MD
Contact
+6285240864987
yuanti.yunus@ui.ac.id

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