Evaluation of Sleep Quality, Nutrition, Anxiety and Depression in Mastalgia

Study Overview
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Brief Summary
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The aim of this study is to investigate the sleep quality, anxiety and depression levels in women with mastalgia using internationally validated scales. Additionally the investigators aim to question the amount and frequency of consumption of nutritional elements which are known to aggravate mastalgia. Finally by combining and analyzing the information gathered, the investigators intend to set light to the etiopathologic and clinic aspects of mastalgia.

Detailed Description
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Mastalgia is encountered in 70% of premenopausal women and is one of the most frequent reasons for attending general surgery clinics. In most of the cases no physical cause is demonstrated and the etiopathogenesis is still not yet determined. In 1949 Patey, for the first time, proposed that mastalgia might be a psychologically based problem. In the following years, research was focused in this issue and some articles were published demonstrating the relationship of anxiety, depression and high stress levels with mastalgia. The efforts for finding out the etiopathologic mechanism and defining the risk factors revealed that smoking and consumption of tea, coffee and carbonated beverages in particular worsen mastalgia whereas essential fatty acids (especially gamma linoleic acid) provides a symptomatic relief. Additionally it is known that sleep irregularities cause serious deterioration in daily life quality as well as can exaggerate some medical, neurologic and/or psychiatric conditions. More than half of the population experience sleep irregularities from time to time and chronic sleep disturbances effect 20% of adult population in western countries. Therefore sleep irregularities might have contributing effects in the etiopathogenesis and/or symptomatology of therapy resistant conditions like mastalgia.

Official Title
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Evaluation of Sleep Quality, Nutrition, Anxiety and Depression in Mastalgia

Conditions
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Mastodynia

Intervention / Treatment
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* Diagnostic Test: Hospital anxiety and depression scale
* Diagnostic Test: Pittsburgh Sleep Quality Index
* Behavioral: Nutritional Status Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having mastalgia as a presenting symptom (mastalgia group) Presence of mastalgia confirmed by a general surgeon (mastalgia group) Absence of mastalgia (control group) Exclusion Criteria: Previously diagnosed breast carcinoma (both groups) Previously exposed to thoracic radiotherapy (both groups) Previous breast or thoracic surgery for any reason (both groups) Presence of Tietze syndrome (both groups) Use of nutritional supplements (both groups) Presence of any self-perceived pain (control group) Presence of psychogenic based conditions and psychosomatic illnesses (control group)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mastalgia<br>Mastalgia group will consist of women with confirmed mastalgia. The patients will be asked to fulfill the forms of Hospital Anxiety and Depression Scale and Pittsburgh Sleep Quality Index. Additionally patients will be asked to inform the frequency and amount of consumption of certain nutritional elements by a questionnaire. | Diagnostic Test: Hospital anxiety and depression scale<br>* Self assessment scale suitable for hospital community as well as public community. Applying the scale does not require any psychopathologic training.<br>Diagnostic Test: Pittsburgh Sleep Quality Index<br>* Self assessment scale for public community. Applying the scale does not require any specially trained personnel.<br>Behavioral: Nutritional Status Questionnaire<br>* It consists of 26 items, questioning the frequency and amount of certain nutritional elements (ones known to worsen and benefit mastalgia) consumed by the individual.<br>|
| Controls<br>Controls group will consist of women attending to general surgery clinic for reasons other than mastalgia. The patients will be asked to fulfill the forms of Hospital Anxiety and Depression Scale and Pittsburgh Sleep Quality Index. Additionally patients will be asked to inform the frequency and amount of consumption of certain nutritional elements by a questionnaire. | Diagnostic Test: Hospital anxiety and depression scale<br>* Self assessment scale suitable for hospital community as well as public community. Applying the scale does not require any psychopathologic training.<br>Diagnostic Test: Pittsburgh Sleep Quality Index<br>* Self assessment scale for public community. Applying the scale does not require any specially trained personnel.<br>Behavioral: Nutritional Status Questionnaire<br>* It consists of 26 items, questioning the frequency and amount of certain nutritional elements (ones known to worsen and benefit mastalgia) consumed by the individual.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Score | Hospital Anxiety and Depression Score is four point likert type scale. It consists of 14 questions. Questions 1, 3, 5, 7, 9, 11 and 13 address anxiety whereas questions 2, 4, 6, 8, 10, 12 and 14 address depression. Achievable minimum score of the scale is 0 and the maximum score is 42. The cut-off score for depression is 7 and for anxiety is 10. Scores higher than 7 indicate high anxiety levels and scores higher than 10 indicate the presence of depression. | 9 months | 
| Pittsburgh Sleep Quality Index | Pittsburgh Sleep Quality Index consists of 7 component. The possible scoring range of the scale is 0-21. The high scores indicates bad sleep quality. The cutt-off value is 5. | 9 months | 
| The amount of nutritional elements consumed which worsen mastalgia | Calculated as the number stated by the individual (times consumed per day/week/month) | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of other nutritional elements consumed | Calculated as the number stated by the individual (times consumed per day/week/month) | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mastodynia, anxiety, depression, sleep quality