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

January 1, 2022 updated by: Alirıza Erdoğan, Nigde Omer Halisdemir University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
217

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Niğde, Turkey, 51100
        • Niğde Ömer Halisdemir University Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Self assessment scale suitable for hospital community as well as public community. Applying the scale does not require any psychopathologic training.
Diagnostic test: Pittsburgh Sleep Quality Index
Self assessment scale for public community. Applying the scale does not require any specially trained personnel.
Behavioral: Nutritional Status Questionnaire
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
"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
Self assessment scale suitable for hospital community as well as public community. Applying the scale does not require any psychopathologic training.
Diagnostic test: Pittsburgh Sleep Quality Index
Self assessment scale for public community. Applying the scale does not require any specially trained personnel.
Behavioral: Nutritional Status Questionnaire
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Score
Time Frame: 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.
9 months
Pittsburgh Sleep Quality Index
Time Frame: 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.
9 months
The amount of nutritional elements consumed which worsen mastalgia
Time Frame: 9 months
Calculated as the number stated by the individual (times consumed per day/week/month)
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The amount of other nutritional elements consumed
Time Frame: 9 months
Calculated as the number stated by the individual (times consumed per day/week/month)
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nigde Omer Halisdemir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020/86

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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