Research on Interventions for Anxiety in Cataract Patients Using Preoperative Music Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Salivary Cortisol Levels
研究概览
简要总结
The researchers designed this study to investigate whether implementing preoperative music intervention in cataract surgery can reduce perioperative anxiety, alleviate postoperative pain, and enhance patient satisfaction with the surgical procedure.
详细描述
This is a single-center, randomized controlled single-blind trial. Computer-generated randomization will be used to allocate patients into two groups: a control group (without music therapy) and music therapy group A (listening to music preoperatively). Patient anxiety levels, pain intensity, satisfaction with the surgical procedure, and degree of cooperation during surgery will be assessed through preoperative and postoperative questionnaires and salivary cortisol measurements. Blood pressure and heart rate will be monitored both preoperatively and intraoperatively.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the diagnostic criteria for cataract
- •Age ≤ 90 years
- •Scheduled for phacoemulsification with IOL implantation under topical anesthesia at the Ophthalmology Department of Guangzhou First People's Hospital
- •Voluntarily participates and provides signed informed consent
排除标准
- •Requires complex and prolonged surgery, such as:
- •Shallow anterior chamber with risk of glaucoma
- •Advanced cataracts with hard nuclei
- •Small pupils
- •Has hearing impairment or communication difficulties
- •Shows significant anxiety/depression tendencies or has a history of mental illness with prior/current use of sedatives
- •Refuses to participate, or has difficulty understanding/answering questionnaires, or has cognitive impairments
- •Uses medications that may affect cortisol and cardiovascular reactivity, including:
- •Oral contraceptives
- •Thyroid drugs
- •Psychotropic drugs
- •Diagnosed with autoimmune diseases (e.g., Sjögren's syndrome) or oral diseases with inflammation/active lesions
结局指标
主要结局
Salivary Cortisol Levels
时间窗: Operational day
Saliva samples were collected at admission and 15 minutes postoperatively using Salivette tubes, centrifuged, and stored at -80°C. Cortisol concentrations were measured via ELISA using the R\&D Systems Cortisol Assay Kit (Cat. No. KGE008B)
SATI simplified questionnaire
时间窗: Operational day
Anxiety was assessed using the SATI simplified questionnaire (6 items, Likert scale 1-4, 1 = none, 4 = severe)
Visual Analog Scale
时间窗: Operational day
Visual Analog Scale (VAS, 0-10, 0 = no anxiety, 10 = extreme anxiety)
次要结局
- Blood pressure(Operational day)
- Intraoperative Pain(Operational day)
- Heart rate(Operational day)
- Respiratory rate(Operational day)
- The patient's cooperation(Operational day)