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临床试验/NCT05904392
NCT05904392已完成不适用

Effect of Music Therapy on the Anxiety Level of Patients During the Administration of Ocular Intravitreal Injections

Althaia Xarxa Assistencial Universitària de Manresa2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
STAI

研究概览

简要总结

Introduction Ocular intravitreal injection is a widely used ophthalmic invasive technique to administer medication directly inside the patient's eye. Despite being usually a quick and painless intervention, some patients report nervousness and anxiety before and during the procedure. Music therapy could help in assessing this discomfort, as previous studies have shown it can beneficial, specially helping to reduce anxiety levels.

Objective This study aims to assess the effect of music therapy on patients undergoing intravitreal injections and how it affects their anxiety.

Methods This is a randomized, prospective, single blind, clinical trial. Patients will be divided into two groups. Group A patients will listen to classical music during the procedure (intervention). Group B patients (control), will not listen to music during the procedure. All other aspects of the procedure will be the same for both groups. To analyze the impact music therapy, patients will fill in the STAI anxiety questionnaire and will be evaluated with the pain visual analogue scale (VAS) before and after the injection procedure.

Expected results Subjects that undergo the procedure with music therapy are expected to experience less anxiety that the ones that do not. Less pain perception is also expected.

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
Double (Investigator, Outcomes Assessor)

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

  • Patients must be at least 18 years old.
  • Patients must have been prescribed an intravitreal injections of an anti-VEGF drug.
  • Subjects must have undergone at least one previous intravitreal injection.
  • Patients must fully understand the procedure and the project they will be participating in and agree on signing the informed consent.

排除标准

  • Patients with a psychiatric diagnosis with the need to take anxiety medication.
  • Patients that before the intervention took medication to relax, such as benzodiazepines or anxiolytics.
  • Subjects with hearing difficulty.

研究组 & 干预措施

Intervention

Experimental

Music played prior to intravitreal injection

干预措施: Music (Other)

Control

No Intervention

No music played.

结局指标

主要结局

STAI

时间窗: Just before and immediately after intervention

Change in anxiety score test

次要结局

未报告次要终点

研究者

发起方
Althaia Xarxa Assistencial Universitària de Manresa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eduard Pedemonte-Sarrias

MD, PhD

Althaia Xarxa Assistencial Universitària de Manresa

研究点 (2)

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