Menstrual CycleNCT05821439
The Effect of Menstruation on Food Preference and Balance
An observational study of Menstrual Cycle, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Apr 2023to 21 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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,
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
HAZAL genç
Istanbul, 34070
HAZAL genç, phd
About this study
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.
Read the 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.
- Conditions
- Menstrual Cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
star excursion balance test
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.
Measured: one month
Food Record
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.
Measured: one month
General Anxiety Disorder
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.
Measured: one month
One Leg Standing Test
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.
Measured: one month
Premenstrual Syndrome Scale
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 .
Measured: one month
Secondary outcomes (2)
Three Factor Nutrition Questionnaire
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.
Measured: one month
Physical Activity Questionnaire
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".
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start23 Apr 2023
- Primary completion24 May 2023 (estimated)
- Study completion21 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821439
- Sponsor's protocol ID
- menstruation
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Souza LB, Martins KA, Cordeiro MM, Rodrigues YS, Rafacho BPM, Bomfim RA. Do Food Intake and Food Cravings Change during the Menstrual Cycle of Young Women? Rev Bras Ginecol Obstet. 2018 Nov;40(11):686-692. doi: 10.1055/s-0038-1675831. Epub 2018 Nov 28.
PubMed 30485899
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Menstruation on Food Preference and Balance
- ClinicalTrials.gov ID
- NCT05821439
- Acronym / sponsor ID
- menstruation
- Conditions
- Menstrual Cycle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- 24 May 2023 (estimated)
- Study completion
- 21 Jul 2023 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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 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.
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 .
2 secondary outcomes
Three Factor Nutrition Questionnaire
Time frame: one month
Physical Activity Questionnaire
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 30485899Souza LB, Martins KA, Cordeiro MM, Rodrigues YS, Rafacho BPM, Bomfim RA. Do Food Intake and Food Cravings Change during the Menstrual Cycle of Young Women? Rev Bras Ginecol Obstet. 2018 Nov;40(11):686-692. doi: 10.1055/s-0038-1675831. Epub 2018 Nov 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cycle, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HAZAL GENÇ, PhD (05413204291, hazaloksuz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
star excursion balance test (time frame: one month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05821439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.