跳至主要内容
临床试验/NCT04781231
NCT04781231终止不适用

Impact of Music Added to the Usual Treatment on the Anxiety of Patients Undergoing Outpatient Cataract Surgery With Topical Anesthesia: Randomized Controlled Trial

Fondation Ophtalmologique Adolphe de Rothschild2 个研究点 分布在 1 个国家目标入组 411 人开始时间: 2021年6月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
411
试验地点
2
主要终点
Self-assessed anxiety score between the 3 groups Description

研究概览

简要总结

Most patients treated for cataract surgery benefit from a short outpatient course with topical local anesthesia.

Having to undergo surgery, especially on the eye, without being asleep, can be stressful. Sometimes waiting in a waiting room with other patients can increase this stress. Patient anxiety may increase blood pressure potentially leading to the prescription of nicardipine to allow surgery to be performed. The patient's anxiety also increases the surgeon's stress, which can alter the conditions for performing the intervention and increase the risk of intraoperative complications.

Besides the administration of anxiolytics, nurses have few options for patients with anxiety. However, the treatment response time is not always appropriate and the patient's cooperation during the procedure can sometimes be impaired.

The effect of music on preoperative anxiety has been evaluated in several studies and has shown a significant decrease in anxiety before surgery.

MusicCare® is a "digital treatment" based on the principles of hypnoanalgesia which has been tested in the management of patients with various pathologies (depression, Alzheimer's disease, chronic pain, etc.) and has shown relative effectiveness. the absence of intervention on the pain and anxiety of patients.

In the context of cataract surgery with topical local anesthesia, we would like to assess the contribution of offering the MusicCare® listening device on patients' anxiety about absence

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
None

盲法说明

Participant in the group Usual care are unaware of the other groups, in order to avoir the Hawthorne effect.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First cataract surgery (first eye)
  • Patient scheduled for short outpatient cataract surgery with topical anesthesia

排除标准

  • Pregnant or breastfeeding woman.

结局指标

主要结局

Self-assessed anxiety score between the 3 groups Description

时间窗: baseline day, before entering the operating room

Self-assessed anxiety score on a visual analogue scale (VAS) from 0 to 10 (0 means no anxiety and 10 the maximum anxiety imaginable)

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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