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The aim of this clinical trial is to prove that acupuncture therapy combined with standard therapy can optimize hemodynamics and reduce pain in post-craniotomy patients with mechanical ventilation. The main questions it aims to answer are:
Researchers will compare acupuncture therapy combined with standard therapy to standard therapy only
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The acupuncture and standard therapy |
|
| Control Group | Active Comparator | Standard therapy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the acupuncture therapy | Procedure | Acupuncture is performed for 3 consecutive days, using filiform needles in the chest, hands, feet area with 20 minutes retention during therapy and using press needle on the forehead which are retained for 3 days and after 3 days the stick needles will be removed. And patient continue to receive standard therapy in accordance with the clinical practice guidelines of the ICU Tangerang Hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure | Average arterial pressure during one cardiac cycle of systole and diastole | Before therapy, Day 4 |
| Heart Rate | Measurement of the participant's pulse rate over one minute. | Before therapy, Day 4 |
| Respiration Rate | Measurement of the participant's respiratory rate over one minute. | Before therapy, Day 4 |
| Oxygen Fraction | Oxygen concentration in the inhaled gas mixture, as displayed on the patient monitor. | Before therapy, Day 4 |
| Critical care Pain Observation Tools | Pain assessment in non-verbal and mechanically ventilated patients, including facial expressions, body movements, muscle tension, and compliance. | Before therapy, Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator Mode | Changes in the type of ventilator settings used for the participant. | Day 4 |
| Side Effect | Patient-reported complaints after receiving manual acupuncture therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KPEK FKUI-RSCM | the Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Indonesia | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
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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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The acupuncture therapy combined with standard therapy will be designated as the intervention group, while the standard therapy only will be designated as the control group
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the outcome assessors will be blinded to group allocation
|
| Standard therapy | Other | Pharmacological therapy provided by the doctor in charge of anesthesia science patients to the research subjects was in accordance with existing clinical practice guidelines. In the ICU of Tangerang Hospital, the standard therapy given to post-craniotomy patients with mechanical ventilation is analgesic and sedation. This standard therapy is also given according to the patient's clinical condition |
|
| Day 4 |