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

Completed

• Conditions: Mastodynia
• Interventions: Diagnostic Test: Hospital anxiety and depression scale; Diagnostic Test: Pittsburgh Sleep Quality Index; Behavioral: Nutritional Status Questionnaire

• Registration Number: NCT04690218
• Lead Sponsor: Nigde Omer Halisdemir University

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.

Study Timeline

• Study First Submitted: 2020-12-26
• Study First Submitted QC: 2020-12-26
• Study First Posted: 2020-12-30
• Study Start: 2021-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-01
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 217

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mastalgia	Hospital anxiety and depression scale	"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.
Mastalgia	Pittsburgh Sleep Quality Index	"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.
Controls	Pittsburgh Sleep Quality Index	"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.
Controls	Hospital anxiety and depression scale	"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.
Controls	Nutritional Status Questionnaire	"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.
Mastalgia	Nutritional Status Questionnaire	"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.

Primary Outcome Measures

Name	Time	Method
The amount of nutritional elements consumed which worsen mastalgia	9 months	Calculated as the number stated by the individual (times consumed per day/week/month)
Pittsburgh Sleep Quality Index	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	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.

Secondary Outcome Measures

Name	Time	Method
The amount of other nutritional elements consumed	9 months	Calculated as the number stated by the individual (times consumed per day/week/month)

Trial Locations

Locations (1)

Niğde Ömer Halisdemir University Training and Research Hospital; 🇹🇷 Niğde, Turkey