NCT06558266

Brief Summary

Hormonal fluctuations occur during the menstrual cycle and can affect cognition. For example, an increase in estrogen levels has been reported to temporarily enhance auditory perception of newly formed stimuli. It has been suggested that fluctuations in hormone levels can alter cognitive performance throughout the menstrual cycle because these fluctuations impact the neurobiology of the brain regions involved in cognition and emotion processing. Mental imagery (MI) refers to the mental process in which an individual imagines performing a movement without actually executing the movement. The effects of hormonal fluctuations on cognitive-perceptual skills have been mentioned above. In light of the above information, this study was planned to examine the relationship between menstrual symptom characteristics and mental imagery ability and to compare women s mental imagery abilities according to the phases of the menstrual cycle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 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 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 12, 2025

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

July 29, 2024

Last Update Submit

March 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Motor Imagery Skill

    The Vividness of Movement Imagery Questionnaire-2 will be used to assess the vividness of participants' movement imagery ability. In the questionnaire, a total of 12 different actions are imagined, and the questionnaire has three subscales (Internal Visual Imagery, External Visual Imagery, and Kinesthetic Imagery). A 5-point Likert scale (1: Perfectly clear and vivid as a normal vision - 5: No image at all: Only know you are thinking of the movement) is used to score each action, and the total score for each subscale ranges from 1 to 60.

    In 1 month period

Secondary Outcomes (2)

  • Menstrual Symptoms

    at baseline

  • Menstrual Pain

    at baseline

Study Arms (1)

menstrual cycle monitoring group

Female students between 18-25 with regular menstrual cycles

Other: Since this was an observational study, no intervention was performed.

Interventions

Since it is an observational study, only evaluation will be made. Each participant s mental imagery ability will be evaluated with the Movement Imagery Vividness Questionnaire-2 four times, follicular phase, ovulation, luteal phase and menstrual phase. In addition, the pain intensity experienced during menstruation will be evaluated with the Numerical Classification Scale-11, and the symptoms experienced due to menstruation will be evaluated with the Menstruation Symptom Scale.

menstrual cycle monitoring group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The universe of the study consists of female students studying at Izmir University of Economics. With the permission of the Dean of the Faculty of Health Sciences of Izmir University of Economics, an announcement e-mail will be sent to all female students to inform them about the study and a list of volunteers will be created via the participation link. 151 female students who meet the study criteria will be included with the systematic sampling method. An "Informed Volunteer Consent Form" will be obtained from individuals who accept to participate in the study.

You may qualify if:

  • Being a woman between the ages of 18-25,
  • Having a regular menstrual cycle,

You may not qualify if:

  • Using neuropsychiatric medication that may affect perception and cognitive skills.
  • People who do not participate in any of the four assessments will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir University of Economics

Izmir, İzmir, 35330, Turkey (Türkiye)

Location

Study Officials

  • Seda Yakıt Yeşilyurt, PhD

    Izmir University of Economics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 16, 2024

Study Start

May 1, 2024

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

March 12, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations