Relationship Between Dysphonia And Anxiety In Fibromyalgia

Sponsor
Umraniye Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05410756
Collaborator
(none)
50
1
3
16.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Assessment of Voice Quality and Function

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 Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Relationship Between Dysphonia And Anxiety In Fibromyalgia Syndrome
Actual Study Start Date :
Mar 1, 2022
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
FIBROMYALGIA GROUP

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

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.

HEALTHY CONTROL GROUP

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

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Umraniye Training and Research Hospital Istanbul Turkey 34000

Sponsors and Collaborators

  • Umraniye Education and Research Hospital

Investigators

  • Principal Investigator: Özlem Aslan, Umraniye Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Özlem Kaleoğlu Aslan, Director, Umraniye Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT05410756
Other Study ID Numbers:
  • B.10.1.THK.4.34.H.GP.0.01
First Posted:
Jun 8, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Özlem Kaleoğlu Aslan, Director, Umraniye Education and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022