Effect of Music Therapy on the Anxiety Level of Patients During the Administration of Ocular Intravitreal Injections
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
- 否
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
Music played prior to intravitreal injection
干预措施: Music (Other)
Control
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
Eduard Pedemonte-Sarrias
MD, PhD
Althaia Xarxa Assistencial Universitària de Manresa
