Relationship Between Dysphonia And Anxiety In Fibromyalgia

Completed

• Conditions: Anxiety Disorders; Dysphonia; Fibromyalgia
• Interventions: Diagnostic Test: Assessment of Voice Quality and Function

• Registration Number: NCT05410756
• Lead Sponsor: Umraniye Education and Research Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2022-03-01
• Status Verified: 2022-06
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Study First Submitted: 2022-06-04
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-08
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FIBROMYALGIA GROUP	Assessment of Voice Quality and Function	Patients diagnosed with Fibromyalgia Syndrome (n=25) who volunteered to be undergone voice analysis.
HEALTHY CONTROL GROUP	Assessment of Voice Quality and Function	Healthy volunteers (n=25) without any chronic disease not under any medication volunteered to be undergone voice analysis.

Primary Outcome Measures

Name	Time	Method
Beck Anxiety Questionary Score	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	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.

Trial Locations

Locations (1)

Umraniye Training and Research Hospital; 🇹🇷 Istanbul, Turkey