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The goal of this clinical trial is to learn if press needle acupuncture works to treat preoperative anxiety in Tympanoplasty and Mastoidectomy at RSUD Kabupaten Tangerang in adults. The main questions it aims to answer are:
Does the press-needle acupuncture administered one day before tympanoplasty and mastoidectomy significantly reduce preoperative anxiety levels-measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)-compared with the sham press-needle group at 30 minutes after the intervention and 60 minutes before anesthesia induction?
Is there a difference in effectiveness between press-needle acupuncture and sham press-needle acupuncture in influencing Heart Rate Variability (HRV) among patients undergoing tympanoplasty and mastoidectomy at 30 minutes after the intervention, 60 minutes before anesthesia induction, 2 hours postoperatively, and 24 hours postoperatively?
Are there any adverse events associated with the use of press-needle acupuncture and sham press-needle acupuncture in patients with preoperative anxiety undergoing tympanoplasty and mastoidectomy?
Participants will:
Receive press-needle acupuncture or sham press-needle acupuncture one day before surgery Have the press needles left in place for a total of 3 days Undergo removal of the needles before hospital discharge Complete preoperative anxiety assessments and routine monitoring according to the study schedule
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Press Needle Acupuncture |
|
| Control Group | Sham Comparator | Sham press needle acupuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The press needle acupuncture | Device | Insertion of acupuncture needles (Pyonex, Korea) measuring 0.2 × 0.9 mm at the auricular acupuncture points Micro Acupuncture - Triangular Fossa1 (MA-TF1) Shenmen, Micro Acupuncture - Anti Tragus2 (MA-AT2) Thalamus, and Micro Acupuncture - Inferior Concha7 (MA-IC7) Heart unilaterally (on the ear opposite to the surgical side), and insertion of a 0.2 × 1.5 mm press needle at the body point Extra - Head Neck3 (EX-HN3). The needles are inserted one day before surgery, with no stimulation performed either during insertion or while the press needles remain in place. Participants are instructed not to touch the application sites until the needles are removed. |
| Measure | Description | Time Frame |
|---|---|---|
| The Amsterdam Preoperative Anxiety and Information Scale (APAIS) | The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a questionnaire consisting of six items rated on a 5-point Likert scale. These six items are divided into three components: anxiety related to anesthesia, anxiety related to the surgical procedure, and the need-for-information component. Higher scores indicate higher levels of preoperative anxiety and a greater need for information. | Baseline, 30 minutes post-intervention, 60 minutes before anesthesia induction |
| Heart Rate Variability (HRV) | Heart rate variability measurements using an HRV monitor (Polar H10) for 5 minutes in the seated position, with the corresponding application operated on the research assistant's smartphone. | Baseline, 30 minutes post-intervention, 60 minutes before anesthesia induction, 2 hours postoperatively, 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | Reactions that occur during or after press-needle application, documented observationally using a monitoring sheet. | Immediately after the intervention |
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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 and Dr. Cipto Mangunkusumo National Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Indonesia | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
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The press needle acupuncture therapy will be designated as the intervention group, while the sham press needle acupuncture therapy will be designated as the control group
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The participants and the outcome assessors will be blinded to group allocation
|
| The sham press needle acupuncture | Device | Application of round adhesive patches with a diameter resembling that of a press needle at the auricular points Micro Acupuncture - Triangular Fossa1 (MA-TF1) Shenmen, Micro Acupuncture - Anti Tragus2 (MA-AT2) Thalamus, and Micro Acupuncture - Inferior Concha7 (MA-IC7) Heart unilaterally (on the ear opposite to the surgical side), as well as at the body point Extra - Head Neck3 (EX-HN3). The patches are applied one day before surgery, with no stimulation performed either during application or while the patches remain in place. Participants are instructed not to touch the application sites until the patches are removed. |
|
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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