The Use of Delta-Wave Hypnosis as a Non-Pharmacological Adjunct to Reduce Perioperative Anxiety During Cataract Surgery: A Prospective, Randomized, Single-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Amsterdam Preoperative Anxiety and Information Scale (APAIS)
研究概览
简要总结
This prospective, randomized, single-blind trial evaluated the effect of delta-wave binaural beat audio hypnoanalgesia, a non-pharmacological hypnosis technique, on reducing perioperative anxiety and improving hemodynamic stability during cataract surgery performed under local anesthesia. A total of 198 patients were randomized into two groups: one group received delta-wave auditory stimulation, while the control group received standard care without auditory intervention. The primary outcomes measured included changes in anxiety levels, assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS), as well as heart rate and blood pressure parameters.
详细描述
This prospective interventional study aimed to assess the efficacy of delta-wave auditory hypnoanalgesia, a non-pharmacological adjunct technique, during cataract surgery performed under regional anesthesia. Patients in the hypnosis group received binaural beats with delta-frequency waves through headphones before and during the operation. The control group received no auditory stimulation. Hemodynamic parameters including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were recorded, alongside assessments of anxiety using the Amsterdam Preoperative Anxiety and Information Scale (APAIS), pain measured by the Numeric Rating Scale (NRS), bispectral index (BIS) monitoring, and patient satisfaction scores at various time points. The findings support the anxiolytic effect of delta-wave hypnoanalgesia and suggest its potential role in improving patient comfort and satisfaction during cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75
- •Undergoing cataract surgery under locoregional anesthesia
- •Provided written informed consent
排除标准
- •Hearing impairment
- •Cognitive disorders
- •Requirement for general anesthesia or sedation
- •Refusal to participate
结局指标
主要结局
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
时间窗: Baseline to start of surgery
The total anxiety score ranges from 4 to 20. Higher scores indicate higher levels of preoperative anxiety.
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
时间窗: Baseline to start of surgery
The total anxiety score ranges from 4 to 20. Higher scores indicate higher levels of preoperative anxiety.
次要结局
- Intraoperative heart rate variation(Every 5 minutes throughout the surgical procedure)
- Intraoperative blood pressure changes(Intraoperative period (every 5 minutes throughout the surgery))
- Numeric Rating Scale (NRS) for pain(Throughout the surgical procedure (intraoperative period))
- Bispectral Index Score (BIS)(Throughout the surgical procedure)
- Satisfaction score from patient, surgeon, and anesthesiologist (0-10 scale)(Immediately after surgery (Day 0))
- Intraoperative blood pressure changes(Intraoperative period (every 5 minutes throughout the surgery))
- Numeric Rating Scale (NRS) for pain(Throughout the surgical procedure (intraoperative period))
- Intraoperative heart rate variation(Every 5 minutes throughout the surgical procedure)
- Bispectral Index Score (BIS)(Throughout the surgical procedure)
- Satisfaction score from patient, surgeon, and anesthesiologist (0-10 scale)(Immediately after surgery (Day 0))