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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 59
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Indonesia
Universitas Indonesia
RECRUITING
Jakarta Pusat
Contact Information
Primary
Miranda Hartini Marpaung, MD
miranda.hartini21@ui.ac.id
081288699204
Time Frame
Start Date: 2026-01-18
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 32
Treatments
Experimental: Intervention Group
Press Needle Acupuncture
Sham_comparator: Control Group
Sham press needle acupuncture
Related Therapeutic Areas
Sponsors
Leads: Indonesia University

This content was sourced from clinicaltrials.gov

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