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This study will look at whether press-needle ear acupuncture can help lower nausea and vomiting caused by antituberculosis medicines in people with pulmonary tuberculosis. Nausea and vomiting are common side effects of tuberculosis treatment, and they can make people stop taking their medicines
When treatment is stopped too early, tuberculosis may not be cured and may become resistant to medicines.
Participants in this study will have nausea and vomiting related to their tuberculosis treatment. They will be randomly assigned to one of two groups. One group will receive press-needle ear acupuncture. The other group will receive a placebo version that looks similar but does not stimulate acupuncture points
Researchers will check nausea and vomiting scores before treatment, during treatment, and after treatment to see whether press-needle acupuncture works better than placebo and whether it is safe. Press-needle acupuncture may help reduce nausea and vomiting by affecting nerves and lowering certain chemicals that trigger these symptoms, and it has minimal side effects
If this method is proven helpful and safe, it may give patients a comfortable and low-risk way to manage nausea and vomiting during tuberculosis treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Press Needle Group | Experimental | Press Needle |
|
| Sham Press Needle Group | Sham Comparator | Sham Press Needle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Press Needle | Device | Press needle is performed once at bilateral MA-TF1 Shenmen, MA-AH-7 Sympathetic, and MA-IC6 Stomach using Press Needle (Pyonex® 0,17x0,9 mm). Standard aseptic procedures are followed. Participants continue their routine pharmacological anti-emetics treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Rhodes indeks of nausea, vomiting, and retching (RINVR) | a validated patient-reported questionnaire used to measure the severity and impact of nausea, vomiting, and retching. It consists of eight items that evaluate the frequency, duration, and distress associated with these symptoms over a specific time period. Each item is scored using a Likert scale, and the total score reflects the overall symptom burden. | Baseline, 1 day, 3 days, 7 days, 10 days, 14 days after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Related to Intervention | Any adverse events occurring after the intervention, including infection, pain, or skin irritation at the insertion site, will be monitored and recorded. | 1 day, 3 days, 7 days, 10 days, 14 days after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin Supratman, MD | Contact | 08128080897 | kevin.supratman@ui.ac.id | |
| KEPK RSUPP | Contact | 0214891708 | ethics@rsuppersahabatan.co.id |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUP Persahabatan | Recruiting | Jakarta | Jakarta Timur | 13230 | Indonesia |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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The intervention group will receive press needle, while the control group will receive sham press needle
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Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
|
| Sham Press Needle | Device | Press needle is performed once at bilateral MA-TF1 Shenmen, MA-AH-7 Sympathetic, and MA-IC6 Stomach using Sham Press Needle. Standard aseptic procedures are followed. Participants continue their routine pharmacological anti-emetics treatment. |
|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |