Anxiety
Conditions
Brief summary
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
Interventions
DEVICEThe press needle acupuncture
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.
DEVICEThe sham press needle acupuncture
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.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participants and the outcome assessors will be blinded to group allocation
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed and scheduled for elective tympanoplasty and mastoidectomy under general anesthesia who experience preoperative anxiety. * Patients aged 18-59 years. * American Society of Anesthesiologists (ASA) physical status I-II. * Patients who have not taken any anti-anxiety medication within the past 24 hours. * Willing to participate in the study until completion and sign the informed consent form.
Exclusion criteria
* Patients with a history of psychiatric disorders or those taking psychotropic medications. * Presence of contraindications to acupuncture, including medical emergencies, pregnancy, thrombocytopenia with platelet count \<50,000/µL, and any history of bleeding disorders. * Presence of infection, scarring, or malignancy at the acupuncture site. * Anatomical abnormalities of the auricle. * History of hypersensitivity reactions to prior acupuncture therapy (such as metal allergy, keloids, or other cutaneous hypersensitivity reactions).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Amsterdam Preoperative Anxiety and Information Scale (APAIS) | Baseline, 30 minutes post-intervention, 60 minutes before anesthesia induction | 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. |
| Heart Rate Variability (HRV) | Baseline, 30 minutes post-intervention, 60 minutes before anesthesia induction, 2 hours postoperatively, 24 hours postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects | Immediately after the intervention | Reactions that occur during or after press-needle application, documented observationally using a monitoring sheet. |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORKPEK FKUI-RSCM
the Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
Outcome results
None listed