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临床试验/NCT04690218
NCT04690218已完成不适用

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

Nigde Omer Halisdemir University1 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
217
试验地点
1
主要终点
The amount of nutritional elements consumed which worsen mastalgia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Having mastalgia as a presenting symptom (mastalgia group)
  • Presence of mastalgia confirmed by a general surgeon (mastalgia group)
  • Absence of mastalgia (control group)

排除标准

  • 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)

结局指标

主要结局

The amount of nutritional elements consumed which worsen mastalgia

时间窗: 9 months

Calculated as the number stated by the individual (times consumed per day/week/month)

Pittsburgh Sleep Quality Index

时间窗: 9 months

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.

Hospital Anxiety and Depression Score

时间窗: 9 months

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.

次要结局

  • The amount of other nutritional elements consumed(9 months)

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alirıza Erdoğan

Principal Investigator

Nigde Omer Halisdemir University

研究点 (1)

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