ClinicalTrials.gg
CompletedNCT05410756Updated Jun 15, 2022

Relationship Between Dysphonia And Anxiety In Fibromyalgia

An observational study in Dysphonia, Fibromyalgia and Anxiety Disorders, sponsored by Umraniye Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-15.

Sponsored by Umraniye Education and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Dysphonia
  • Fibromyalgia
  • Anxiety Disorders

Keywords

  • anxiety
  • fibromyalgia
  • dysphonia
03

In context

Dysphonia

132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.

This study's enrollment of 50 is below the median of 123 across 40 observational studies indexed under Dysphonia.

Browse Dysphonia studies →

Lead sponsor

Umraniye Education and Research Hospital is the lead sponsor of 61 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

25 patients diagnosed with fibromyalgia syndrome

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with Fibromyalgia syndrome for at least 1 year
  • Minimum VAS score of 3

Exclusion criteria

Exclusion Criteria:

  • Patients with diabetes mellitus,
  • other rheumatological diseases,
  • ,
  • connective tissue disorders
  • neuromuscular diseases and
  • hereditary diseases.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • FIBROMYALGIA GROUP

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

    Diagnostic Test: Assessment of Voice Quality and Function

  • 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

Interventions

  • Diagnostic testAssessment 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at the start of the study

  2. 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.

    Time frame: at the start of the study

07

Study locations

1 site
  • Umraniye Training and Research Hospital
    Istanbul, 34000, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2022 to primary completion in Jun 2022, 3 months.

Of 18 observational studies under Dysphonia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 193. This study's 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2022
First posted
Jun 8, 2022
StartActual
Mar 1, 2022
Primary completionActual
Jun 1, 2022
CompletionActual
Jun 1, 2022
Last update
Jun 15, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05410756
Lead sponsor
Umraniye Education and Research Hospital
Responsible party
Özlem Kaleoğlu Aslan (Director, Umraniye Education and Research Hospital) — Principal investigator
First posted
Jun 8, 2022
Start date
Mar 1, 2022
Primary completion
Jun 1, 2022
Completion
Jun 1, 2022
Last update
Jun 15, 2022

Study contacts

Özlem Aslan
principal investigator · Umraniye Education and Research Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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