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临床试验/NCT05410756
NCT05410756已完成不适用

Relationship Between Dysphonia And Anxiety In Fibromyalgia Syndrome

Umraniye Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022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
50
试验地点
1
主要终点
Beck Anxiety Questionary Score

研究概览

简要总结

Our aim in conducting this study is to determine the relationship between voice disorders and anxiety in patients with fibromyalgia syndrome (FS).

详细描述

This case controlled study was performed at the Physical Medicine and Rehabilitation outpatient clinic between April 2022 and June 2022. 25 patients who were diagnosed with FS according to the 2010 American College of Rheumatology (ACR) criteria were included in the study. For the control group 25 healthy volunteers with no previous chronic disease history were included . The investigators planed to investigate the relationship between the anxiety level of the FS patients and dysphonia. Thus an acoustic voice analysis (fundamental frequency (F0), jitter, shimmer, noise to harmonic ratio (NHR), harmonic to noise ratio (HNR)) and an aerodynamic analysis (maximal phonation time (MPT)) were performed by an experienced otolaryngologist specialized in voice disorders for evaluation of objective voice quality and function. These analyses were performed on all the volunteers from both groups, and the results obtained were compared between the groups.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Fibromyalgia syndrome for at least 1 year
  • Minimum VAS score of 3

排除标准

  • Patients with diabetes mellitus,
  • other rheumatological diseases,
  • malignancies,
  • connective tissue disorders
  • neuromuscular diseases and
  • hereditary diseases.

结局指标

主要结局

Beck Anxiety Questionary Score

时间窗: at the start of the study

Measuring The Anxiety level, It is scored between 0-63. The greater the score the greater the anxiety level of the subject.

Visual Analogue Scale (VAS) Score

时间窗: at the start of the study

Visual Analogue Scale is used to measure the pain level of the subjects. It is scored between 0 to 10. Greater score corresponds to greater pain sensation.

次要结局

未报告次要终点

研究者

发起方
Umraniye Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Özlem Kaleoğlu Aslan

Director

Umraniye Education and Research Hospital

研究点 (1)

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