Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT06981533
Eligibility Criteria:
Inclusion Criteria:
* Female students aged 18 to 25 with active menstrual cycles and menstrual periods ranging from 25 to 35 days.
* Participants must be able to accurately recall the start date of their most recent menstruation cycle.
* Participants must exhibit symptoms of Premenstrual Syndrome (PMS) and meet the diagnostic criteria for PMS as defined by the American College of Obstetricians and Gynecologists (ACOG) 2014.
* Participants must not have any chronic conditions, including respiratory diseases (e.g., asthma, pneumonia, chronic obstructive pulmonary disease), thyroid disorders, autonomic nervous system disorders, hypertension, coronary artery disease, or diabetes, as determined through clinical examination, medical history, and prior medical records.
* Participants must not have severe psychological stress (a score lower than 27 on the Perceived Stress Scale - PSS-10).
* Participants must be mentally alert and in good contact with the researcher.
* Participants must voluntarily consent to participate in the study.
* Participants must not have prior knowledge of auricular acupuncture or auricular acupressure.
Exclusion Criteria:
* Infection or lesions in the ear area (e.g., scars, tears, abrasions).
* Menstrual cycles shorter than 25 days or longer than 35 days.
* Participants unable to recall the start date of their most recent menstruation cycle.
* Participants diagnosed with gynecological conditions such as uterine fibroids, endometriosis, or ovarian cysts, based on medical history and recent abdominal ultrasound results (within the past 6 months).
* History of abortion, currently pregnant, or planning to become pregnant during the study period.
* Use of antidepressants and/or antipsychotic drugs, hormone supplements, oral contraceptives, or intrauterine devices within the past two months.
* Current or past psychiatric disorders.
* Participants with severe psychological stress (a score between 27 and 40 on the PSS-10).
* Unstable mental state, sensory impairments (e.g., hearing, vision, speech), or cognitive disabilities.
* Previous auricular acupressure, acupuncture, or other forms of acupuncture for PMS treatment within the last 6 months.
* Use of medication for PMS symptom relief during the study period.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
25 Years
Study:
NCT06981533
Study Brief:
Protocol Section:
NCT06981533