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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The manual acupuncture and standard therapy |
|
| Control Group | Sham Comparator | The sham acupuncture and standard therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual acupuncture and standard therapy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton anxiety rating scale (HAM-A) score | One tool to measure the degree of anxiety symptoms is a questionnaire. Scores range from 0-56. | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ C30) score | Questionnaire to assess the quality of life of cancer patients with anxiety. Scores range from 0-100 | 6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KEPK FKUI-RSCM | The Health Research Ethics Commitee of Faculty of Medicine | Principal Investigator |
| KEPK RS Kanker Dharmais | The Health Research Ethics Commitee of Dharmais Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Indonesia | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia | ||
| RS Kanker Dharmais |
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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
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The participants, and outcome assessors will be blinded to group allocation
|
| Sham acupuncture and standard therapy | Procedure | 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. |
|
| Jakarta |
| 11420 |
| Indonesia |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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