RecruitingNot Applicable

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

Indonesia32 participantsStarted 2026-01-18

Plain-language 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

Who can participate

Age range

18 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Amsterdam Preoperative Anxiety and Information Scale (APAIS)

Timeframe: Baseline, 30 minutes post-intervention, 60 minutes before anesthesia induction

Heart Rate Variability (HRV)

Timeframe: Baseline, 30 minutes post-intervention, 60 minutes before anesthesia induction, 2 hours postoperatively, 24 hours postoperatively

Trial details

NCT IDNCT07278284

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31

Contact for this trial

Miranda Hartini Marpaung, MD

081288699204 miranda.hartini21@ui.ac.id

View on ClinicalTrials.gov More Anxiety trials