Relationship Between Dysphonia And Anxi… | Clinical Trial

Key information

Conditions

Dysphonia Anxiety Disorders Fibromyalgia Laryngeal Diseases Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Rheumatic Diseases Signs and Symptoms Voice Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Umraniye Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assessment of Voice Quality and Function

Diagnostic Test

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.

Primary outcomes

Beck Anxiety Questionary Score

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Umraniye Education and Research Hospital

Other Gov

Registry information

Official study title

Relationship Between Dysphonia And Anxiety In Fibromyalgia Syndrome

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jun 8, 2022
Registry last updated: Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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