Clinical trial NCT04690218: Evaluation of Sleep Quality, Nutrition, Anxiety and Depression in Mastalgia
Official title: Evaluation of Sleep Quality, Nutrition, Anxiety and Depression in Mastalgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mastodynia
Keywords: mastodynia
anxiety
depression
sleep quality
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 217
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This case-controlled study will consist of 2 groups; Mastalgia group (women with confirmed mastalgia) and controls (women without mastalgia).

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Hospital Anxiety and Depression Score
timeFrame: 9 months
measure: Pittsburgh Sleep Quality Index
timeFrame: 9 months
measure: The amount of nutritional elements consumed which worsen mastalgia
timeFrame: 9 months
Secondary outcomes:
measure: The amount of other nutritional elements consumed
timeFrame: 9 months
Other outcomes:
Locations:
city: Niğde
country: Turkey
facility: Niğde Ömer Halisdemir University Training and Research Hospital
Study officials:
References:
citation: Kanat BH, Atmaca M, Girgin M, Ilhan YS, Bozdag A, Ozkan Z, Yazar FM, Emir S. Effects of Mastalgia in Young Women on Quality of Life, Depression, and Anxiety Levels. Indian J Surg. 2016 Apr;78(2):96-9. doi: 10.1007/s12262-015-1325-5. Epub 2015 Aug 28.
citation: PATEY DH. Two common non-malignant conditions of the breast; the clinical features of cystic disease and the pain syndrome. Br Med J. 1949 Jan 15;1(4593):96-9. doi: 10.1136/bmj.1.4593.96. No abstract available.
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