The Effects of Music and Television on Intraoperative Hypertensive Events in Cataract Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Intraoperative hypertensive event
研究概览
简要总结
This study investigates whether television viewing or music listening can reduce pre-operative anxiety and improve surgical outcomes for patients undergoing cataract surgery. It aims to determine the effectiveness of these interventions compared to a control group and assess their impact on physiological markers of anxiety as well as the incidence of intra-operative hypertensive events.
The key questions that are to be answered are:
- Does watching television before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients?
- Does listening to music before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients?
详细描述
The study addresses the gap in literature regarding TV viewing's efficacy in ophthalmic surgery anxiety reduction. It aims to provide insights into cost-effective methods for stress reduction and surgical optimization. Through voluntary participation and rigorous methodology, it seeks to enhance patient experience and outcomes in ophthalmic surgery.
- Study Design: Randomized controlled design with three groups: control, television intervention, or music intervention.
- Objective: Investigate effects of TV viewing and music listening on pre-operative anxiety in ophthalmic surgery.
- Comparison: Compare relaxation effects of TV and music.
- Participants: Aim to recruit 200 per intervention arm from Montefiore Medical Center.
- Baseline Assessment: Measure anxiety levels pre-intervention.
- Interventions: Administer TV or music for 20 minutes pre-surgery.
- Assessment: Evaluate anxiety levels and physiological markers pre- and post-intervention.
- Monitoring: Monitor vital signs during surgery and post-operative period.
- Data Collection: Document demographic info, medical history, and baseline anxiety.
- Measurement Tools: Use Visual Analog Scale (VAS) for subjective assessment and physiological markers.
- Analysis: Compare outcomes across intervention arms using statistical tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants undergoing cataract surgery at Montefiore Medical Center
排除标准
- •Participants with severe hearing loss or speech impairment
- •Participants with vision loss greater than count fingers
- •Participants with uncontrolled hypertension (defined as >160/>100 despite use of antihypertensive medication)
- •Participants who do not have the capacity to provide consent or who require a surrogate to provide consent
结局指标
主要结局
Intraoperative hypertensive event
时间窗: From beginning of cataract surgery to the completion (approximately 15 minutes)
The primary outcome of this study is the occurrence of one hypertensive event (defined as BP \>160/\>100) during the procedure (cataract surgery).
次要结局
- Change in Blood pressure measurements for Anxiety(From participant enrollment to after 20 minute intervention)
- Change in Heart Rate measurements for Anxiety(From participant enrollment to after 20 minute intervention)
- Change in VAS-A measurements for Anxiety(From participant enrollment to after 20 minute intervention)