The Effectiveness of Press Needle Acupuncture on Preoperative Anxiety in Tympanoplasty and Mastoidectomy at RSUD Kabupaten Tangerang
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The Amsterdam Preoperative Anxiety and Information Scale (APAIS)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants and the outcome assessors will be blinded to group allocation
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Intervention Group
Press Needle Acupuncture
干预措施: The press needle acupuncture (Device)
Control Group
Sham press needle acupuncture
干预措施: The sham press needle acupuncture (Device)
结局指标
主要结局
The Amsterdam Preoperative Anxiety and Information Scale (APAIS)
时间窗: Baseline, 30 minutes post-intervention, 60 minutes before anesthesia induction
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.
Heart Rate Variability (HRV)
时间窗: Baseline, 30 minutes post-intervention, 60 minutes before anesthesia induction, 2 hours postoperatively, 24 hours postoperatively
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.
The Amsterdam Preoperative Anxiety and Information Scale (APAIS)
时间窗: Baseline, 30 minutes post-intervention, 60 minutes before anesthesia induction
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.
Heart Rate Variability (HRV)
时间窗: Baseline, 30 minutes post-intervention, 60 minutes before anesthesia induction, 2 hours postoperatively, 24 hours postoperatively
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.
次要结局
- Side effects(Immediately after the intervention)
- Side effects(Immediately after the intervention)
研究者
Miranda Hartini Marpaung
Principal Investigator
Indonesia University