DysphoniaNCT05410756
Relationship Between Dysphonia And Anxiety In Fibromyalgia
An observational study of Dysphonia and Fibromyalgia, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Our aim in conducting this study is to determine the relationship between voice disorders and anxiety in patients with fibromyalgia syndrome (FS). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphonia, Fibromyalgia, Anxiety Disorders
- What is being tested?
- Assessment of Voice Quality and Function
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 25 patients diagnosed with fibromyalgia syndrome
Who may be able to join
- Diagnosed with Fibromyalgia syndrome for at least 1 year
- Minimum VAS score of 3
Who cannot join
- Patients with diabetes mellitus,
- other rheumatological diseases,
- malignancies,
- connective tissue disorders
- neuromuscular diseases and
- hereditary diseases.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Umraniye Training and Research Hospital
Istanbul, 34000
About this study
Official title: Relationship Between Dysphonia And Anxiety In Fibromyalgia Syndrome
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.
- Conditions
- Dysphonia, Fibromyalgia, Anxiety Disorders
- Being tested
- Assessment of Voice Quality and Function
- Keywords
- anxiety, fibromyalgia, dysphonia
- Medical subject headings
- Dysphonia, Fibromyalgia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Voice Quality and FunctionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| FIBROMYALGIA GROUP | Patients diagnosed with Fibromyalgia Syndrome (n=25) who volunteered to be undergone voice analysis. Receives: 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. Receives: Diagnostic Test: Assessment of Voice Quality and Function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the start of the study
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.
Measured: at the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Mar 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Özlem Kaleoğlu Aslan, Umraniye Education and Research Hospital
- Investigators
- Özlem Aslan, Principal investigator, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410756
- Sponsor's protocol ID
- B.10.1.THK.4.34.H.GP.0.01
- Status last verified
- Jun 2022
- First submitted
- 4 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Dysphonia And Anxiety In Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT05410756
- Acronym / sponsor ID
- B.10.1.THK.4.34.H.GP.0.01
- Conditions
- Dysphonia, Fibromyalgia, Anxiety Disorders
- Keywords
- anxiety, fibromyalgia, dysphonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our aim in conducting this study is to determine the relationship between voice disorders and anxiety in patients with fibromyalgia syndrome (FS).
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIBROMYALGIA GROUP | – | Diagnostic Test: Assessment of Voice Quality and FunctionPatients diagnosed with Fibromyalgia Syndrome (n=25) who volunteered to be undergone voice analysis. |
| HEALTHY CONTROL GROUP | – | Diagnostic Test: Assessment of Voice Quality and FunctionHealthy volunteers (n=25) without any chronic disease not under any medication volunteered to be undergone voice analysis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 25 patients diagnosed with fibromyalgia syndrome
Key inclusion criteria (2 listed)
- Diagnosed with Fibromyalgia syndrome for at least 1 year
- Minimum VAS score of 3
Key exclusion criteria (6 listed)
- Patients with diabetes mellitus,
- other rheumatological diseases,
- malignancies,
- connective tissue disorders
- neuromuscular diseases and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of Voice Quality and FunctionAn 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. | Diagnostic test | FIBROMYALGIA GROUP, HEALTHY CONTROL GROUP |
Primary outcome
Beck Anxiety Questionary Score
Time frame: 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.
Visual Analogue Scale (VAS) Score
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özlem Aslan principal investigator
Umraniye Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphonia and Fibromyalgia, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Questionary Score (time frame: at the start of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.