Randomized Controlled Trial of the STEIN Protocol: A Neuroplastic Pain Education and Guided Breathing Intervention During Awake Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Total cumulative intraoperative dose of anxiolytic and analgesic medications (midazolam [mg], fentanyl [mcg], and additional rescue medications, recorded separately).
研究概览
简要总结
This randomized controlled trial evaluates whether a standardized perioperative neuroplastic intervention: the STEIN Protocol (Strategies and Techniques for Enhancing Integration and Neuroplasticity), consisting of pain neuroscience education, guided imagery, and paced breathing, reduces intraoperative analgesic and anxiolytic requirements.
Secondary outcomes include patient-reported pain, anxiety, satisfaction, and postoperative recovery following cataract surgery.
Reduced intraoperative sedative and analgesic requirements may reflect improved patient comfort and autonomic regulation while minimizing medication-related adverse effects.
详细描述
The STEIN Protocol is a randomized behavioral intervention designed to evaluate whether standardized, non-pharmacologic interventions can help patients have a more comfortable and safe surgical experience.
Cataract surgery provides a highly standardized operative model with minimal procedural variability, making it well suited for evaluating perioperative behavioral interventions while minimizing confounding from surgical complexity.
The intervention is based on contemporary models of pain neuroscience, which propose that cognitive appraisal, expectancy, autonomic regulation, and attentional processes influence pain perception independent of tissue injury.
Participants in the study will receive standard cataract surgery, with some patients also taking part in the STEIN Protocol. This includes watching a short educational video before surgery, following slow, guided breathing during the procedure, and practicing brief breathing exercises at home for one week after surgery. The intervention is designed to reduce sympathetic arousal and promote parasympathetic regulation through standardized paced breathing and guided cognitive attention.
The intervention is intended to modify cognitive appraisal, attentional focus, and autonomic regulation, thereby influencing pain perception throughout the perioperative period.
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 (Care Provider, Investigator)
盲法说明
Surgeons and anesthesia providers will not be informed of treatment allocation before or during surgery. Intervention audio is delivered through open-ear headphones, and participants are instructed not to disclose intervention content. Medication administration follows a standardized patient-directed protocol to minimize the potential influence of treatment allocation.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults undergoing elective cataract surgery under topical anesthesia who are able to provide informed consent and complete study procedures.
排除标准
- •Inability to provide informed consent Inability to comply with study procedures Complex or combined cataract surgery General anesthesia Medical, neurologic, psychiatric, or respiratory conditions interfering with study participation Requirement for modified anesthetic protocols Inability to complete postoperative breathing exercises or follow-up assessments
研究组 & 干预措施
Control
干预措施: Control (Device)
Music + Guided Imagery
Music and Guided Imagery
干预措施: Music and Guided Imagery (Device)
Music Only
Music Only
干预措施: Music Only (Device)
结局指标
主要结局
Total cumulative intraoperative dose of anxiolytic and analgesic medications (midazolam [mg], fentanyl [mcg], and additional rescue medications, recorded separately).
时间窗: From initiation of surgery until completion of surgery.
次要结局
- Iowa Satisfaction with Anesthesia Scale (ISAS)(Within 30 minutes of surgery completion)
- Numeric Rating Scale pain score (0-10)(Within 30 minutes of surgery completion)
- Amsterdam Preoperative Anxiety and Information Scale (APAIS)(30 minutes prior to surgery)
- Additional questions(Within 30 minutes after surgery completion)
研究者
Shawn R. Lin, MD, MBA
Associate Clinical Professor of Ophthalmology
University of California, Los Angeles