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

University of Indonesia (UI)

Status: Enrolling

Conditions: Anxiety

Treatments: Device: The press needle acupuncture; Device: The sham press needle acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07278284

25-11-1709

Details and patient eligibility

About

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

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

32 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Press Needle Acupuncture

Treatment:

Device: The press needle acupuncture

Control Group

Sham Comparator group

Description:

Sham press needle acupuncture

Treatment:

Device: The sham press needle acupuncture