Menstrual CycleNCT06789354
Body Awareness and Perception Across Menstrual Phases:
An observational study of Menstrual Cycle, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The study explores the dynamic interplay between body awareness and body perception across the menstrual cycle's phases, emphasizing hormonal influences on these dimensions. Conducted with 43 female participants aged 18-35, this research highlights significant variability in body-related experiences tied to hormonal… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 147 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 May 2020to 29 Dec 2024
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female volunteers aged 18-35 years with regular menstrual cycles (28 ± 2 days) participated in the study,
Who may be able to join
- female volunteers
- aged 18-35 years
- regular menstrual cycles
Who cannot join
- not using hormonal contraceptives in the preceding six months
- having no history of gynecological disorders
- having no chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body Awareness and Perception Across Menstrual Phases: A Multidimensional Perspective
The study explores the dynamic interplay between body awareness and body perception across the menstrual cycle's phases, emphasizing hormonal influences on these dimensions. Conducted with 43 female participants aged 18-35, this research highlights significant variability in body-related experiences tied to hormonal fluctuations.
The study aims to address the gap in understanding how menstrual cycle phases impact women's body awareness-sensitivity to physiological states-and body perception, encompassing self-image and physical self-evaluation.
Read the detailed description
Methods: Participants were divided based on menstrual phases: follicular, ovulatory, and luteal. Hormonal fluctuations were tracked through menstrual calendars and ovulation kits. Tools such as the Body Awareness Questionnaire (BAQ) and Multidimensional Body-Self Relations Questionnaire (MBSRQ) assessed participants' awareness and perception. Other assessments included the Premenstrual Syndrome Scale (PMS), Menstruation Attitude Scale (MAS), and physical activity tracking through the IPAQ-SF questionnaire.
Limitations The reliance on self-reported data and single-cycle assessments are noted as constraints, suggesting the need for longitudinal studies for greater robustness.
- Conditions
- Menstrual Cycle
- Being tested
- Questionnaire and Physical Exam
- Keywords
- Body Awareness, Menstrual Cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
All assessments were carried out face-to-face with the same physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Female volunteers aged 18-35 years with regular menstrual cycles | Not described Receives: Other: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Awareness Questionnaire (BAQ)
The Body Awareness Questionnaire (BAQ) is a self-assessment tool consisting of 18 items divided into four subscales (16). These subscales evaluate attentiveness to (1) bodily processes, including changes and reactions in the body, (2) the sleep-wake cycle, (3) the ability to predict the onset of illness, and (4) the prediction of bodily reactions. The questionnaire employs a 7-point Likert scale for scoring, where higher scores reflect greater body awareness. The BAQ has a total possible score ranging from a minimum of 18 to a maximum of 126. The Turkish adaptation of the BAQ, including validity and reliability analyses, was conducted by Karaca and Bayar, ensuring its applicability in Turkish-speaking populations (17).
Measured: through study completion, an average of 1 year
Body Perception Scale (BPS)
The Multidimensional Body-Self Relations Questionnaire (MBSRQ), developed by Cash, is a self-report Likert-type scale designed to assess the structure of body image and attitudinal components of self-perception (18). The original instrument comprises 69 items, which evaluate three psychological dimensions characterized by emotional, cognitive, and behavioral traits, as well as three physical dimensions: physical appearance, physical competence, and biological integrity. The cognitive and behavioral aspects were subsequently consolidated under the category of 'orientation,' resulting in six distinct subscales within the questionnaire. An additional subscale, 'satisfaction with body domains,' was later introduced, bringing the total to seven subgroups. Lower mean scores on the MBSRQ indicate the presence of body image disturbances, providing valuable insights into individuals' attitudes and perceptions toward their bodies (18,19
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start23 May 2020
- Primary completion1 Sep 2024
- Study completion29 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789354
- Sponsor's protocol ID
- 27.02.2020/29
- Status last verified
- Dec 2024
- First submitted
- 13 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not prefer
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Awareness and Perception Across Menstrual Phases: A Multidimensional Perspective
- ClinicalTrials.gov ID
- NCT06789354
- Acronym / sponsor ID
- 27.02.2020/29
- Conditions
- Menstrual Cycle
- Keywords
- Body Awareness, Menstrual Cycle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 23 May 2020 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 29 Dec 2024 (actual)
- First posted
- 23 Jan 2025 (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.
The study explores the dynamic interplay between body awareness and body perception across the menstrual cycle's phases, emphasizing hormonal influences on these dimensions. Conducted with 43 female participants aged 18-35, this research highlights significant variability in body-related experiences tied to hormonal fluctuations.
The study aims to address the gap in understanding how menstrual cycle phases impact women's body awareness-sensitivity to physiological states-and body perception, encompassing self-image and physical self-evaluation.
Detailed description
Methods: Participants were divided based on menstrual phases: follicular, ovulatory, and luteal. Hormonal fluctuations were tracked through menstrual calendars and ovulation kits. Tools such as the Body Awareness Questionnaire (BAQ) and Multidimensional Body-Self Relations Questionnaire (MBSRQ) assessed participants' awareness and perception. Other assessments included the Premenstrual Syndrome Scale (PMS), Menstruation Attitude Scale (MAS), and physical activity tracking through the IPAQ-SF questionnaire.
Limitations The reliance on self-reported data and single-cycle assessments are noted as constraints, suggesting the need for longitudinal studies for greater robustness.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female volunteers aged 18-35 years with regular menstrual cycles | – | Other: Questionnaire and Physical Exam |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female volunteers aged 18-35 years with regular menstrual cycles (28 ± 2 days) participated in the study,
Key inclusion criteria (3 listed)
- female volunteers
- aged 18-35 years
- regular menstrual cycles
Key exclusion criteria (3 listed)
- not using hormonal contraceptives in the preceding six months
- having no history of gynecological disorders
- having no chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical ExamAll assessments were carried out face-to-face with the same physiotherapist. | Other | Female volunteers aged 18-35 years with regular menstrual cycles |
Primary outcome
Body Awareness Questionnaire (BAQ)
Time frame: through study completion, an average of 1 year
The Body Awareness Questionnaire (BAQ) is a self-assessment tool consisting of 18 items divided into four subscales (16). These subscales evaluate attentiveness to (1) bodily processes, including changes and reactions in the body, (2) the sleep-wake cycle, (3) the ability to predict the onset of illness, and (4) the prediction of bodily reactions. The questionnaire employs a 7-point Likert scale for scoring, where higher scores reflect greater body awareness. The BAQ has a total possible score ranging from a minimum of 18 to a maximum of 126. The Turkish adaptation of the BAQ, including validity and reliability analyses, was conducted by Karaca and Bayar, ensuring its applicability in Turkish-speaking populations (17).
Body Perception Scale (BPS)
Time frame: through study completion, an average of 1 year
The Multidimensional Body-Self Relations Questionnaire (MBSRQ), developed by Cash, is a self-report Likert-type scale designed to assess the structure of body image and attitudinal components of self-perception (18). The original instrument comprises 69 items, which evaluate three psychological dimensions characterized by emotional, cognitive, and behavioral traits, as well as three physical dimensions: physical appearance, physical competence, and biological integrity. The cognitive and behavioral aspects were subsequently consolidated under the category of 'orientation,' resulting in six distinct subscales within the questionnaire. An additional subscale, 'satisfaction with body domains,' was later introduced, bringing the total to seven subgroups. Lower mean scores on the MBSRQ indicate the presence of body image disturbances, providing valuable insights into individuals' attitudes and perceptions toward their bodies (18,19
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No. I do not prefer
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Marmara University 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 23 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Awareness Questionnaire (BAQ) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2025.