跳至主要内容
临床试验/NCT04641065
NCT04641065已完成不适用

Effects of Traditional Turkish Military Music on Pain, Anxiety and Vital Signs in Patients With Endoscopic Retrograde Cholangiopancreatography

Afyonkarahisar Health Sciences University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年3月1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
72
试验地点
1
主要终点
Visual Analog Scale for Anxiety (VAS-A)

研究概览

简要总结

This study aims to investigate the effect of Traditional Turkish Military music on patients who will have Endoscopic Retrograde Cholangio-Pancreatography Procedure on vital signs, anxiety, and pain. This will be a randomized controlled experimental study.

The study will be conducted with two groups: the intervention group (n=36) and the control group (n=36). The control group will receive standard care while the intervention group, in addition to standard care, will be listened to Traditional Turkish Military music, which consists of music selected by an expert on the type of music, by the researchers for 15 minutes before the procedure.

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

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 aged 18 or above,
  • with a scheduled ERCP procedure
  • with the ASA grade level of I-II clinically
  • without a hearing/speech impairment
  • willing to participate in the research
  • without a mental problem or diagnosis of psychiatric disorder
  • without any a diagnosis of depression

排除标准

  • patients below 18 years of age,
  • Patients with an emergency ERCP procedure
  • with a hearing/speech impairment
  • not willing to participate in the research
  • with a mental problem or diagnosis of psychiatric disorder
  • with a diagnosis of depression

结局指标

主要结局

Visual Analog Scale for Anxiety (VAS-A)

时间窗: 1 Hour

VAS-A is a 10 cm long measuring instrument with the score range from 0 to 10 with 0 points showing "no anxiety" and 10 points showing "I feel a lot of anxiety"

Visual Analog Scale for Pain (VAS)

时间窗: 2 Hours

VAS scale is a single-dimensional scale that is commonly used to evaluate pain severity. According to VAS, pain intensity is rated as "no pain" with 0 points, and "the most severe pain imaginable" with 10 points. Pain intensity ranges were determined by VAS as follows; mild pain below 3 points, as moderate pain between 3 and 6 points, and as severe pain above 6 points.The VAS pain scale was applied to the patients once on the first postoperative day, for the level of pain they felt.

次要结局

  • Vital Signs(4 hours)

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

Assistant Professor PhD

Afyonkarahisar Health Sciences University

研究点 (1)

Loading locations...

相似试验