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临床试验/NCT04212338
NCT04212338已完成不适用

Effect of Music Intervention on Pain, Anxiety, Physiological Variables, Patient Satisfaction, and Surgeon-Patient Cooperation in Intravitreal Injection

Afyonkarahisar Health Sciences University2 个研究点 分布在 2 个国家目标入组 219 人开始时间: 2019年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
219
试验地点
2
主要终点
Visual Analog Scale for Anxiety (VAS-A)

研究概览

简要总结

The objective of this study was to examine the effect of music intervention in the before-intravitreal injection (IVTI) and during-IVTI periods on patients' anxiety, the sensation of pain, physiological variables, satisfaction, and surgeon-patient cooperation. The study used a randomized controlled experimental design. The study was conducted with a total of three groups: two experimental (Before-IVTI (Group1) and During-IVTI music intervention group (Group 2)) and one control group. Each of the experimental and control groups consisted of 75 patients. The patients' anxiety was evaluated using the VAS anxiety scale, pain using the VAS pain scale; surgeon-patient cooperation using the Numeric Rating Scale; and patient satisfaction with a 5-point likert-type satisfaction scale.

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
Single (Participant)

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

  • The participants were patients aged 18 or above,
  • Who did not have a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had not received a diagnosis of depression, who volunteered to participate in the study, and on whom elective IVTI was carried out, or who had undergone IVTI previously.

排除标准

  • The participants were patients aged under 18 years
  • Who had a hearing/speech impairment, a mental problem or a diagnosed psychiatric disorder, who had received a diagnosis of depression, who did not volunteered to participate in the study, and or who had not undergone IVTI previously.

结局指标

主要结局

Visual Analog Scale for Anxiety (VAS-A)

时间窗: 1 day

VAS-A is a measurement tool, in which 0 represents feeling "no anxiety" while 10 represents "I feel extremely anxious".29 An increase in score indicates an increase in the anxiety experienced by the patient. This indicates that VAS-A is a reliable and accurate measurement tool despite its brevity. The VAS-A scale was applied to patients before, immediately after, and 15 minutes after the injection.

次要结局

  • Visual Analog Scale for Pain (VAS)(1 day)

研究者

发起方
Afyonkarahisar Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yeliz Ciğerci

Director

Afyonkarahisar Health Sciences University

研究点 (2)

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