Relationship Between Dysphonia And Anxiety In Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Relationship Between Dysphonia And Anxiety In Fibromyalgia Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05410756
• Other study ID #: B.10.1.THK.4.34.H.GP.0.01
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Dysphonia
• Fibromyalgia
• Hoarseness
• Myofascial Pain Syndromes

Intervention

Diagnostic Test:
• Assessment of Voice Quality and Function
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.

Locations

Country	Name	City	State
Turkey	Umraniye Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Anxiety Questionary Score	Measuring The Anxiety level, It is scored between 0-63. The greater the score the greater the anxiety level of the subject.	at the start of the study
Primary	Visual Analogue Scale (VAS) Score	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.	at the start of the study