NCT05821439

Brief 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. These changes in the menstrual cycle can affect women physiologically and psychologically.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

April 23, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

April 6, 2023

Last Update Submit

April 23, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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 .

    one month

Secondary Outcomes (2)

  • Three Factor Nutrition Questionnaire

    one month

  • Physical Activity Questionnaire

    one month

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMenstrual Period
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Having completed the age of 18,
  • Not over 45 years old and not in menopause,
  • Not having any diagnosed psychological disease,

You may not qualify if:

  • Individuals who menstruate with medical treatment every month,
  • Individuals with lower extremity disability,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HAZAL genç

Istanbul, 34070, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30485899BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2023

First Posted

April 20, 2023

Study Start

April 23, 2023

Primary Completion

May 24, 2023

Study Completion

July 21, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations