NCT06789354

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
Last Updated

January 23, 2025

Status Verified

December 1, 2024

Enrollment Period

4.3 years

First QC Date

January 13, 2025

Last Update Submit

January 17, 2025

Conditions

Keywords

Body AwarenessMenstrual Cycle

Outcome Measures

Primary Outcomes (2)

  • 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).

    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

    through study completion, an average of 1 year

Study Arms (1)

Female volunteers aged 18-35 years with regular menstrual cycles

Other: Questionnaire and Physical Exam

Interventions

All assessments were carried out face-to-face with the same physiotherapist.

Female volunteers aged 18-35 years with regular menstrual cycles

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsthe research based on menstrual cycle.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Female volunteers aged 18-35 years with regular menstrual cycles (28 ± 2 days) participated in the study,

You may qualify if:

  • female volunteers
  • aged 18-35 years
  • regular menstrual cycles

You may not qualify if:

  • not using hormonal contraceptives in the preceding six months
  • having no history of gynecological disorders
  • having no chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Surveys and QuestionnairesRestraint, Physical

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilization

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 23, 2025

Study Start

May 23, 2020

Primary Completion

September 1, 2024

Study Completion

December 29, 2024

Last Updated

January 23, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

I do not prefer

Locations