MenstruationNCT06558266
Mental Imagery in Menstrual Cycle Phases
An observational study of Menstruation and Mental Imagery, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstruation, Mental Imagery, Menstrual Cycles
- How many people
- 168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 Mar 2025
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Being a woman between the ages of 18-25,
- Having a regular menstrual cycle,
- Being a volunteer Exclusion criteria
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir University of Economics
Izmir, İzmir, 35330
About this study
Official title: Comparison of Mental Imagery Ability According to Menstrual Cycle Phases
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.
- Conditions
- Menstruation, Mental Imagery, Menstrual Cycles
- Being tested
- Since this was an observational study, no intervention was performed.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Since this was an observational study, no intervention was performed.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| menstrual cycle monitoring group | Female students between 18-25 with regular menstrual cycles Receives: Other: Since this was an observational study, no intervention was performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: In 1 month period
Secondary outcomes (2)
Menstrual Symptoms
The Menstruation Symptom Scale is one of the scales that evaluates the symptoms experienced due to menstruation in detail. It is a five-point Likert-type scale consisting of twenty-four items. Participants are asked to give a number between 1 (never) and 5 (always) to the symptoms they experience related to menstruation. The MSÖ score is calculated by taking the total score average of the items in the scale. An increase in the score average indicates an increase in the severity of menstrual symptoms. The scale has three sub-dimensions: 'Negative Effects/Somatic Complaints', 'Menstrual Pain' and 'Abdominal Pain'. The score obtained from the sub-dimensions is calculated by taking the total score average of the items in the sub-dimensions.
Measured: at baseline
Menstrual Pain
The numbered classification scale-11 (NSS-11) (0-10) will be used to evaluate menstrual pain. It is a practical and simple method recommended to evaluate the severity and variations of menstrual pain. The participant will be asked to give a score between 0-10 for the severity of pain they perceive/feel during menstruation. "0 means no complaints", "10 means very severe complaints"
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 May 2024
- Primary completion1 Feb 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenstruationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Yakit Yesilyurt, Izmir University of Economics
- Investigators
- Seda Yakıt Yeşilyurt, PhD, Principal investigator, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558266
- Sponsor's protocol ID
- B.30.2.İEÜSB.0.05.05-20-291
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mental Imagery Ability According to Menstrual Cycle Phases
- ClinicalTrials.gov ID
- NCT06558266
- Acronym / sponsor ID
- B.30.2.İEÜSB.0.05.05-20-291
- Conditions
- Menstruation, Mental Imagery, Menstrual Cycles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 16 Aug 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| menstrual cycle monitoring group | – | Other: Since this was an observational study, no intervention was performed.Female students between 18-25 with regular menstrual cycles |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- Being a woman between the ages of 18-25,
- Having a regular menstrual cycle,
- Being a volunteer Exclusion criteria
- 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.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Since this was an observational study, no intervention was performed.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. | Other | menstrual cycle monitoring group |
Primary outcome
Motor Imagery Skill
Time frame: In 1 month period
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.
2 secondary outcomes
Menstrual Symptoms
Time frame: at baseline
Menstrual Pain
Time frame: at baseline
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 12 Mar 2025.
- 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.
Seda Yakıt Yeşilyurt, PhD principal investigator
Izmir University of Economics
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 Menstruation and Mental Imagery, run by Izmir University of Economics 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 5 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: finished, as of the sponsor's last update on 12 Mar 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?
Motor Imagery Skill (time frame: In 1 month period). 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 12 Mar 2025.