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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05410756
Other study ID # B.10.1.THK.4.34.H.GP.0.01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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