Relationship Between Dysphonia And Anxiety In Fibromyalgia

NCT ID: NCT05410756

Last Updated: 2022-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-06-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Dysphonia Fibromyalgia Anxiety Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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FIBROMYALGIA GROUP

Patients diagnosed with Fibromyalgia Syndrome (n=25) who volunteered to be undergone voice analysis.

Assessment of Voice Quality and Function

Intervention Type 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.

HEALTHY CONTROL GROUP

Healthy volunteers (n=25) without any chronic disease not under any medication volunteered to be undergone voice analysis.

Assessment of Voice Quality and Function

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Özlem Kaleoğlu Aslan

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Özlem Aslan

Role: PRINCIPAL_INVESTIGATOR

Umraniye Education and Research Hospital

Locations

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Umraniye Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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B.10.1.THK.4.34.H.GP.0.01

Identifier Type: -

Identifier Source: org_study_id

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