Auricular Acupuncture vs. Standard Therapy for Treatment of Preoperative Anxiety in Patients Scheduled for Ambulatory Gynaecological Surgery - a Pilot Non-randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Situational anxiety_3
研究概览
简要总结
In this prospective nonrandomized study the investigators are going to investigate whether auricular acupuncture with indwelling fixed needles is feasible for treatment of preoperative anxiety.
Patients, scheduled for ambulatory gynecologic surgery, will be asked, if they wish to receive auricular acupuncture (AA) against preoperative anxiety. The patients who will not wish AA, will be asked to take part in questioning (State-Trait-Anxiety-Inventory (STAI) questionnaire) and will form the control group. The preoperative anxiety using STAI, as well as the duration and quality of sleep on the night before surgery, the incidence of side effects, blood pressure and heart rate will be the outcome measures in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with an American Society of Anaesthesiologists physical status of I to II scheduled for elective ambulatory gynaecological surgery under standardized general anaesthesia
- •Surgery time does not exceed 60 minutes
- •Patients without previous opioid and psychotropic medication
- •Patients aged between 19 and 55 years, able to fill in the STAI questionnaire
- •Patients who have given written informed consent
排除标准
- •Current psychiatric disease
- •Local skin infection at the sites of acupuncture
- •Aged < 19 or > 55 years
- •Failure to follow the standardized schema of general anaesthesia
- •Surgery time more than 60 minutes
- •Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)
- •Patients who consumed opioid medication at least 6 months before surgery
- •Patients who are unable to understand the consent form or to fill in the STAI questionnaire
结局指标
主要结局
Situational anxiety_3
时间窗: Situational anxiety_3 will be measured on the day of surgery immediately before the operation
State (situational) anxiety will be measured using State-Trait-Anxiety Inventory
Situational anxiety_1
时间窗: Situational anxiety_1 will be measured on the day before surgery before auricular acupuncture
State (situational) anxiety will be measured using State-Trait-Anxiety Inventory (STAI).
Situational anxiety_2
时间窗: Situational anxiety_2 will be measured and in the evening of the day before surgery
State (situational) anxiety will be measured using State-Trait-Anxiety Inventory
次要结局
- Heart rate(On the day of surgery before the surgery)
- Blood pressure(On the day of surgery before the surgery)