Anxiety, Cancer, Quality of Life
Conditions
Brief summary
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: 1. 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? 2. 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.
Interventions
PROCEDUREManual acupuncture and standard therapy
Manual acupuncture is acupuncture needle insertion was done perpendicularly to the acupuncture points GV20, EXHN3, HT7, and PC6 using Huanqiu needle measuring 0.25 x 25mm with mild stimulation rotation technique at a speed of 60x/minute and needle retention for 30 minutes. Therapy was performed every day for 6 days. Standard therapy is anxiolytic drugs and supportive psychotherapy given to patients according to the decision of the psychiatrist treating the patient.
PROCEDURESham acupuncture and standard therapy
Sham acupuncture is when acupuncture needles are inserted into acupuncture points, but do not actually penetrate the skin, only attached to the plaster. Therapy was performed every day for 6 days. Standard therapy is anxiolytic drugs and supportive psychotherapy given to patients according to the decision of the psychiatrist treating the patient.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participants, and outcome assessors will be blinded to group allocation
Intervention model description
The manual acupuncture and standard therapy will be designed as the intervention group, while the sham acupuncture and standard therapy will be designed as the control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton anxiety rating scale (HAM-A) score | 6 days | One tool to measure the degree of anxiety symptoms is a questionnaire. Scores range from 0-56. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ C30) score | 6 days | Questionnaire to assess the quality of life of cancer patients with anxiety. Scores range from 0-100 |
Countries
Indonesia
Outcome results
None listed