Effect of Bagua Auriculotherapy on Pain in Patients Undergoing Hysteroscopy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Pain Intensity During Hysteroscopy
研究概览
简要总结
To investigate the application of Bagua ear therapy as an adjunctive intervention for perioperative pain management in patients undergoing hysteroscopic surgery, to analyze its effects on intraoperative and postoperative pain, and to compare the differences in pain outcomes between patients undergoing hysteroscopy under local anesthesia and those without anesthesia.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 20 to 45 years
- •Scheduled for diagnostic hysteroscopy
- •American Society of Anesthesiologists (ASA) Physical Status Classification I or II
- •Normal comprehension and communication skills, able to complete Numerical Rating Scale (NRS) and Self-Rating Anxiety Scale (SAS) assessments
- •Willing to provide written informed consent
排除标准
- •Known allergy to auricular plaster or Vaccaria segetalis (Wang Bu Liu Xing) seeds
- •Active lesions on the ear, such as wounds, ulcers, swelling, or deformity
- •Severe psychiatric or neurological disorders
- •Severe cardiovascular or cerebrovascular diseases
- •Pre-existing significant pain, nausea, vomiting, dizziness, or tinnitus before the procedure
研究组 & 干预措施
Paracervical Block Alone Group
Participants receive paracervical block anesthesia (0.1 g lidocaine) as the pain management intervention. No auriculotherapy is administered.
干预措施: Paracervical block anesthesia (Procedure)
Paracervical Block + Bagua Auriculotherapy Group
Participants receive both paracervical block anesthesia (0.1 g lidocaine) and Bagua auriculotherapy. The auriculotherapy is administered by a trained practitioner starting 15 minutes before surgery and continuing until 30 minutes after the procedure.
干预措施: Paracervical block anesthesia (Procedure)
Paracervical Block + Bagua Auriculotherapy Group
Participants receive both paracervical block anesthesia (0.1 g lidocaine) and Bagua auriculotherapy. The auriculotherapy is administered by a trained practitioner starting 15 minutes before surgery and continuing until 30 minutes after the procedure.
干预措施: Bagua Auriculotherapy (Procedure)
No Anesthesia + No Auriculotherapy Group
Participants receive neither paracervical block anesthesia nor Bagua auriculotherapy during the procedure. Only routine standard care is provided.
Bagua Auriculotherapy Alone Group
Participants receive Bagua auriculotherapy without paracervical block anesthesia. The therapy is administered by a trained practitioner starting 15 minutes before surgery and continuing until 30 minutes after the procedure.
干预措施: Bagua Auriculotherapy (Procedure)
结局指标
主要结局
Pain Intensity During Hysteroscopy
时间窗: During the hysteroscopy procedure and up to 30 minutes post-procedure
Pain intensity measured using the Numerical Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Assessments are performed at five time points: during vaginal disinfection, at hysteroscope insertion, during the procedure, at procedure completion, and 30 minutes post-procedure.
次要结局
- Anxiety Level(before the procedure)
- Patient Satisfaction(After the procedure, before discharge)
- Hemodynamic Parameters(During the hysteroscopy procedure)
- Incidence of Adverse Events(study enrollment through the post-procedure follow-up period)