The Effectiveness of Press Needle Acupuncture on Preoperative Anxiety in Tympanoplasty and Mastoidectomy

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

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

Study Overview

• Status: Recruiting
• Conditions: Anxiety
• Intervention / Treatment: Device: The press needle acupuncture; Device: The sham press needle acupuncture

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miranda Hartini Marpaung, MD; Phone Number: 081288699204; Email: miranda.hartini21@ui.ac.id

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Recruiting
      • Universitas Indonesia
      • Contact: Miranda Hartini Marpaung, MD; Phone Number: 081288699204; Email: miranda.hartini21@ui.ic.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Press Needle Acupuncture	Device: The 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.
Sham Comparator: Control Group; Sham press needle acupuncture	Device: The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: KPEK FKUI-RSCM, The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2026
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 25-11-1709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No