Evaluation of Smell and Taste in Fibromyalgia

Study Overview
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Brief Summary
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Patients diagnosed with fibromyalgia syndrome according to 2016 ACR criteria and 18-70 years old healthy subjects will be included in the study. Their smell and taste will be assessed with sniffin sticks and taste strips. Besides they will be evaluated for quality of life, anxiety, depression, and alexithymia.

Official Title
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Evaluation of Smell and Taste in Patients With Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Sniffin' Sticks test and Taste strips


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-70 years of fibromyalgia patients Giving informed consent Knowing how to write and read in Turkish Exclusion Criteria: Mentally retarded patients Psychiatric disorders (bipolar disorder, schizophrenia etc.) Severe organ failure (kidney, liver, heart failure) History of head trauma Any disorder associated with smell and taste functions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fibromyalgia<br>Diagnosed with ACR 2016 criteria | Other: Sniffin' Sticks test and Taste strips<br>* Sniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen. The taste strips are a validated examination procedure to investigate the taste ability. When testing the whole mouth taste ability, the taste strips are applied by putting them on the tongue and closing the mouth.<br>|
| Control<br>18-70 years healthy subjects | Other: Sniffin' Sticks test and Taste strips<br>* Sniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen. The taste strips are a validated examination procedure to investigate the taste ability. When testing the whole mouth taste ability, the taste strips are applied by putting them on the tongue and closing the mouth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sniffin' Sticks Test Score | total smell test score minimum score: 0 maximum score: 48 Higher scores reflect better smell function. | Baseline | 
| Taste Strips Test Score | total taste score minimum score: 0 maximum score: 16 Higher scores indicate better taste function. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Score | A EQ-5D-3L is a standardized instrument for measuring generic health status. minimum score: -0.59 maximum score: 1 Higher scores indicate better health status. | Baseline | 
| Anxiety Score | Hamilton anxiety scale: Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. | Baseline | 
| Alexithymia Score | Toronto alexithymia scale minimum score: 20 maximum score: 100 Cut-off scores: ≤50=no alexithymia, 51-60=borderline alexithymia, and ≥61=alexithymia | Baseline | 
| Depression Score | Hamilton depression scale is designed to rate the severity of depression in patients. Although it contains 21 areas, calculate the patient's score on the first 17 answers. Minimum score:0 Maximum score: 53 Higher scores reflect more severe depression. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibromyalgia, smell, taste