Press-needle acupuncture to reduce anxiety before tympanoplasty and mastoidectomy

The Effectiveness of Press Needle Acupuncture on Preoperative Anxiety in Tympanoplasty and Mastoidectomy at RSUD Kabupaten Tangerang

This test will see if press-needle acupuncture given one day before surgery reduces anxiety and changes heart rate variability in adults having tympanoplasty or mastoidectomy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 59 Years
• Sex: All
• Sponsor: Indonesia University (Academic / other)
• Locations: 1 site (Jakarta Pusat, DKI Jakarta)
• Trial ID: NCT07278284 on ClinicalTrials.gov

What this trial studies

This interventional, controlled study at Universitas Indonesia compares press-needle acupuncture applied one day before surgery with a sham press-needle in adults undergoing elective tympanoplasty or mastoidectomy. The main outcomes are preoperative anxiety measured with the Amsterdam Preoperative Anxiety and Information Scale (APAIS) at 30 minutes after the intervention and 60 minutes before anesthesia, and heart rate variability (HRV) measured at multiple perioperative timepoints including 2 and 24 hours postoperatively. Eligible participants are adults aged 18–59 years with ASA physical status I–II who have not taken anti-anxiety medication in the prior 24 hours. The protocol also records any adverse events related to press-needle or sham use.

Who should consider this trial

Good fit: Adults aged 18–59 scheduled for elective tympanoplasty or mastoidectomy under general anesthesia who are ASA I–II, have preoperative anxiety, have not taken anti-anxiety medication in the past 24 hours, and can provide informed consent are ideal candidates.

Not a fit: Patients with psychiatric disorders, those taking psychotropic medications, pregnant patients, those with bleeding disorders or thrombocytopenia, auricular anatomical abnormalities, infections or scarring at acupuncture sites, or prior hypersensitivity to acupuncture are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could reduce preoperative anxiety and improve autonomic stability around the time of surgery, potentially making anesthesia induction and recovery smoother.

How similar studies have performed: Some prior acupuncture studies have shown modest reductions in preoperative anxiety, but results are mixed and the specific press-needle auricular approach remains relatively under-studied with limited high-quality evidence.

Eligibility criteria

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).

Where this trial is running

Jakarta Pusat, DKI Jakarta

• Universitas Indonesia — Jakarta Pusat, DKI Jakarta, Indonesia (Recruiting)

Study contacts

• Principal investigator: Kpek Fkui-Rscm — the Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
• Study coordinator: Miranda Hartini Marpaung, MD

Conditions Anxiety