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

Nigde Omer Halisdemir University

Status: Completed

Conditions: Mastodynia

Treatments: Diagnostic Test: Pittsburgh Sleep Quality Index; Diagnostic Test: Hospital anxiety and depression scale; Behavioral: Nutritional Status Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT04690218

2020/86

Details and patient eligibility

About

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.

Full 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.

Enrollment: 217 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

217 participants in 2 patient groups

Mastalgia

Description:

"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.

Treatment:

Diagnostic Test: Pittsburgh Sleep Quality Index

Behavioral: Nutritional Status Questionnaire

Diagnostic Test: Hospital anxiety and depression scale

Controls

Description:

"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.

Treatment:

Diagnostic Test: Pittsburgh Sleep Quality Index

Behavioral: Nutritional Status Questionnaire

Diagnostic Test: Hospital anxiety and depression scale