- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05821439
The Effect of Menstruation on Food Preference and Balance
April 23, 2023 updated by: hazal genc, Istanbul Medipol University Hospital
Menstruation period, which is accepted as the symbol of fertility, and some problems related to this process covers half of a woman's life.
During this period, various changes occur in the female body, especially in the endocrine system.
These changes in the menstrual cycle can affect women physiologically and psychologically.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Premenstrual syndrome (PMS) is an important health problem and negatively affects the quality of life of many women around the world.
It usually begins 2 years after menarche and is known to worsen with age.It is known that approximately 80%-95% of women experience various degrees of PMS-related complaints.
It has been reported that Premenstrual Syndrome can occur with more than 300 symptoms.
The symptoms of PMS can be experienced in varying degrees, such as mild, moderate, and severe.
The rate of those experiencing severe symptoms in PMS varies between 3-8%.
Among the symptoms, psychological symptoms take the most important place.
These; symptoms such as irritability, depression, anxiety, restlessness, nervousness, irritability, outbursts of anger and crying spells, feeling of loss of control, difficulty concentrating, laziness, insomnia or hypersomnia.
The most common physical symptoms are joint, muscle, headache and abdominal pain, acne, edema, dizziness, libido and appetite changes, gastrointestinal disturbances, bloating, weight gain, breast fullness and tenderness.
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: HAZAL genç, phd
- Phone Number: 05413204291
- Email: hazaloksuz@gmail.com
Study Contact Backup
- Name: HAZAL genç
- Phone Number: 05413204291
- Email: hazaloksuz@gmail.com
Study Locations
-
-
-
Istanbul, Turkey, 34070
- Recruiting
- HAZAL genç
-
Contact:
- HAZAL genç, phd
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The study will be conducted using qualitative data with a total of 60 women in the 18-45 age group living in Turkey within 3 months following the ethics committee approval.
Description
Inclusion Criteria
- Having completed the age of 18,
- Not over 45 years old and not in menopause,
- Not having any diagnosed psychological disease,
- It was determined as women who are healthy and have menstruation every month. Exclusion Criteria
- Individuals who menstruate with medical treatment every month,
- Individuals with lower extremity disability,
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 |
---|
Premenstrual period
For the premenstrual period evaluation, the participants' 10 days before menstruation will be taken as a reference.
|
Menstrual period
For the evaluation of the menstrual period, the first 3 days when symptoms are seen more will be taken as a reference.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
star excursion balance test
Time Frame: one month
|
On the previously prepared platform; There are 8 linear lines that form a star shape, arranged at an angle of 45 degrees between them.
Before the test was administered to the individuals, necessary explanations were made and they were informed about the test.
The individual to be tested was positioned to coincide with the very center of this shape.
The untested leg was used to maintain the stability of the body in full contact with the ground.
The tested leg, on the other hand, was asked to extend maximum in different directions and return to the starting position.
|
one month
|
One Leg Standing Test
Time Frame: one month
|
Before starting the test, the desired position was shown to the individuals and it will be explained in which cases the test will be invalid.
This test was planned to be performed on both the right and left legs of the individuals.
The desired position is for the untested leg; hip and leg flexed to 90 degrees, arms free, and the tested leg in full extension.
|
one month
|
Food Record
Time Frame: one month
|
Food records were evaluated in the "Nutrition Determine" program, and each participant received) amounts were calculated.
Selections and intakes of nutrients will be evaluated.
The Three-Factor Eating Questionnaire-Revised 18 Items (TFEQ-R18) consists of 18 items ona 4-point Likert scale (1 = definitely true, 2 = mostly true, 3 = mostly false, 4 = definitely false).Responses to each of the 18 items are summated into scale scores for cognitive restraint, uncontrolledeating, and emotional eating .igher
scores in the respective scales areindicative of greater cognitive restraint, uncontrolled, or emotional eating.
|
one month
|
General Anxiety Disorder
Time Frame: one month
|
It is a test that evaluates the anxiety disorder of individuals with a short and self-reported way.
It questions the emotions and mood changes experienced by individuals in the last 2 weeks.
Each question of this test, which consists of 7 questions, has a 4-point Likert option.
According to the scores obtained from the scale; 5,10,15 are used as cutoff points for mild, moderate and severe anxiety, respectively.
In individuals with a total score of 10 and above, their anxiety should be investigated and confirmed by other methods.
Score 0-4: Minimal Anxiety.
Score 5-9: Mild Anxiety.
Score 10-14: Moderate Anxiety.
Score greater than 15: Severe Anxiety.
|
one month
|
Premenstrual Syndrome Scale
Time Frame: one month
|
Before answering the questions, individuals will be asked to think about the 7 days before menstruation.
The scale consists of 44 questions in five-point Likert type.The lowest score is 44, and 220 is the highest.
If the score (> 132)it will considered a positive Premenstrual Syndrome and as the score gets higher then indicate greater severity of symptoms during Premenstrual Syndrome .
|
one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Three Factor Nutrition Questionnaire
Time Frame: one month
|
With this questionnaire, which is used to evaluate the nutritional habits of individuals, our study measures the degree of conscious restriction of eating, the level of uncontrolled eating, and the degree of emotional eating.
|
one month
|
Physical Activity Questionnaire
Time Frame: one month
|
Physical activity level will be evaluated with the International Physical Activity .Scoring a HIGH level of physical activity on the IPAQ means your physical activity levels equate to approximately one hour of activity per day or more at least a moderate intensity activity level.
intensity activities achieving a minimum total physical activity of at least 3000 MET minutes a week.
Questionnaire (UFAA).
The short form contains a total of 7 questions.
Questionnaire; It allows us to obtain information about the time spent walking, during moderate and vigorous activities, and sitting.
The measurement of all activities performed is based on the fact that each activity is performed for at least 10 minutes at a time.
According to the total physical activity score, the physical activity levels of the participants are defined as "low, medium and high".
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
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)
April 23, 2023
Primary Completion (Anticipated)
May 24, 2023
Study Completion (Anticipated)
July 21, 2023
Study Registration Dates
First Submitted
April 6, 2023
First Submitted That Met QC Criteria
April 6, 2023
First Posted (Actual)
April 20, 2023
Study Record Updates
Last Update Posted (Actual)
April 25, 2023
Last Update Submitted That Met QC Criteria
April 23, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- menstruation
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.
Clinical Trials on Menstrual Cycle
-
Taipei Medical University WanFang HospitalCompletedIrregular Menstrual Cycle | Regular Menstrual CycleTaiwan
-
University of BonnRadboud University Medical Center; University Hospital, BonnRecruiting
-
University of ArizonaCompletedMenstrual CycleUnited States
-
Necmettin Erbakan UniversityNot yet recruitingMenstrual Cycle
-
Universitat Jaume ICompleted
-
Wolfson Medical CenterUnknown
-
Fudan UniversityCompleted
-
AbbottCompletedIrregular Menstrual CycleKazakhstan, Russian Federation, Ukraine, Uzbekistan
-
AbbottCompletedIrregular Menstrual CycleIndia
-
University Hospital TuebingenGerman Research Foundation; Uppsala UniversityNot yet recruiting