Clinical Trials Directory

Trials / Completed

CompletedNCT04690218

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

Status
Completed
Phase
Study type
Observational
Enrollment
217 (actual)
Sponsor
Nigde Omer Halisdemir University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTHospital anxiety and depression scaleSelf assessment scale suitable for hospital community as well as public community. Applying the scale does not require any psychopathologic training.
DIAGNOSTIC_TESTPittsburgh Sleep Quality IndexSelf assessment scale for public community. Applying the scale does not require any specially trained personnel.
BEHAVIORALNutritional Status QuestionnaireIt consists of 26 items, questioning the frequency and amount of certain nutritional elements (ones known to worsen and benefit mastalgia) consumed by the individual.

Timeline

Start date
2021-01-01
Primary completion
2021-12-31
Completion
2021-12-31
First posted
2020-12-30
Last updated
2022-01-04

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04690218. Inclusion in this directory is not an endorsement.