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

NCT04690218 | Completed

• 1 other identifier: 2020/86
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastodynia

Keywords

mastodynia; anxiety; depression; sleep quality

Outcome Measures

Primary Outcomes (3)

• Hospital Anxiety and Depression Score

  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.

  9 months

• Pittsburgh Sleep Quality Index

  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.

  9 months

• The amount of nutritional elements consumed which worsen mastalgia

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

  9 months

Secondary Outcomes (1)

• The amount of other nutritional elements consumed

  9 months

Study Arms (2)

Mastalgia

"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.

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

Controls

"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.

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

Interventions

Hospital anxiety and depression scale DIAGNOSTIC_TEST

Self assessment scale suitable for hospital community as well as public community. Applying the scale does not require any psychopathologic training.

Controls; Mastalgia

Pittsburgh Sleep Quality Index DIAGNOSTIC_TEST

Self assessment scale for public community. Applying the scale does not require any specially trained personnel.

Controls; Mastalgia

Nutritional Status Questionnaire BEHAVIORAL

It consists of 26 items, questioning the frequency and amount of certain nutritional elements (ones known to worsen and benefit mastalgia) consumed by the individual.

Controls; Mastalgia

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Mastalgia group (women with mastalgia) and controls (women without mastalgia)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Niğde Ömer Halisdemir University Training and Research Hospital

Niğde, 51100, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 27303116 BACKGROUND

• 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.

  PMID: 18122751 BACKGROUND

• Preece PE, Mansel RE, Hughes LE. Mastalgia: psychoneurosis or organic disease? Br Med J. 1978 Jan 7;1(6104):29-30. doi: 10.1136/bmj.1.6104.29.

  PMID: 620138 BACKGROUND

• Johnson KM, Bradley KA, Bush K, Gardella C, Dobie DJ, Laya MB. Frequency of mastalgia among women veterans. Association with psychiatric conditions and unexplained pain syndromes. J Gen Intern Med. 2006 Mar;21 Suppl 3(Suppl 3):S70-5. doi: 10.1111/j.1525-1497.2006.00378.x.

  PMID: 16637950 BACKGROUND

• Colegrave S, Holcombe C, Salmon P. Psychological characteristics of women presenting with breast pain. J Psychosom Res. 2001 Jun;50(6):303-7. doi: 10.1016/s0022-3999(01)00196-9.

  PMID: 11438111 BACKGROUND

• Ader DN, South-Paul J, Adera T, Deuster PA. Cyclical mastalgia: prevalence and associated health and behavioral factors. J Psychosom Obstet Gynaecol. 2001 Jun;22(2):71-6. doi: 10.3109/01674820109049956.

  PMID: 11446156 BACKGROUND

• Idiz C, Cakir C, Ulusoy AI, Idiz UO. The Role of Nutrition in Women with Benign Cyclic Mastalgia: A Case-Control Study. Eur J Breast Health. 2018 Jul 1;14(3):156-159. doi: 10.5152/ejbh.2018.3827. eCollection 2018 Jul.

  PMID: 30123881 BACKGROUND

• Soldatos CR, Paparrigopoulos TJ. Sleep physiology and pathology: pertinence to psychiatry. Int Rev Psychiatry. 2005 Aug;17(4):213-28. doi: 10.1080/09540260500104565.

  PMID: 16194793 BACKGROUND

• Barthlen GM, Stacy C. Dyssomnias, parasomnias, and sleep disorders associated with medical and psychiatric diseases. Mt Sinai J Med. 1994 Mar;61(2):139-59.

  PMID: 8022426 BACKGROUND

• Mollayeva T, Thurairajah P, Burton K, Mollayeva S, Shapiro CM, Colantonio A. The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: A systematic review and meta-analysis. Sleep Med Rev. 2016 Feb;25:52-73. doi: 10.1016/j.smrv.2015.01.009. Epub 2015 Feb 17.

  PMID: 26163057 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

MeSH Terms

Conditions

Mastodynia; Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2020
• First Posted: December 30, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)