• STATUS
    Recruiting
  • day left to enroll
    1
  • participants needed
    60
  • sponsor
    University of Medicine and Pharmacy at Ho Chi Minh City
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Updated on 22 May 2025
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Summary

Premenstrual Syndrome (PMS) is a common gynecological disorder that significantly affects the quality of life for women of reproductive age, with symptoms including emotional, behavioral, and physical disturbances occurring approximately one week before menstruation. PMS is especially prevalent among female undergraduate students, who often experience heightened stress due to academic pressures and lack emotional coping strategies. While pharmacological treatments, such as SSRIs and hormonal therapies, have been used to manage PMS symptoms, they may have side effects and are not always effective in the long term. This has led to increasing interest in alternative treatments such as traditional medicine. Auricular acupressure, a non-invasive and low-risk method, has shown promising results in managing PMS symptoms and is gaining attention as a possible solution.

The goal of this clinical trial is to evaluate the efficacy and safety of auricular acupressure in reducing PMS symptoms in female undergraduate students. The main questions it aims to answer are:

  • Does auricular acupressure reduce the severity of PMS symptoms in female undergraduate students?
  • Is auricular acupressure safe and well-tolerated by participants? Researchers will compare the intervention group (receiving auricular acupressure) to the control group (receiving sham auricular acupressure) to see if auricular acupressure has a significant impact on reducing PMS symptoms and improving quality of life.

Participants will:

  • Receive auricular acupressure on specific acupoints or sham treatment.
  • Complete assessments of PMS symptoms using the Premenstrual Symptoms Screening Tool (PSST) at baseline, 1 week, and 8 weeks.
  • Complete a quality of life assessment using the WHOQOL-Bref scale at the same time points.
  • Be monitored for any adverse effects during the 8-week trial period.

Description

Participants and Methods: A randomized, single-blind, controlled trial was conducted with 60 female undergraduate students, aged 18 to 25 years, residing in Ho Chi Minh City, who exhibit symptoms of Premenstrual Syndrome (PMS) were eligible for inclusion. Participants were required to meet the inclusion criteria and not fall under any exclusion criteria.

Participants were randomly assigned into two groups in a 1:1 ratio: the intervention group received auricular acupressure using Cowherb seeds (Wangbuliuxing seeds) applied to specific acupoints, including Shenmen (TF4), Sympathetic (AH6a), Endocrine (CO18), Liver (CO12), Kidney (CO10), Subcortex (AT4), and Zero Point, while the control group received a sham treatment. The sham treatment involved a patch of similar size to the Cowherb seed patch but without any active ingredients, applied to the same acupoint locations as the intervention group.

Both groups were provided with instructions on lifestyle changes to help manage PMS symptoms. The intervention lasted for 8 weeks (2 menstrual cycles), with weekly patch changes alternating between the left and right ears. PMS symptoms were assessed using the Premenstrual Symptoms Screening Tool (PSST), and quality of life was measured using the WHOQOL-Bref scale. Data were collected at baseline, after 1 week, and after 8 weeks. Adverse effects were carefully monitored throughout the study period.

Details
Condition Premenstrual Syndrome
Age 18years - 25years
Clinical Study IdentifierNCT06977009
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City
Last Modified on22 May 2025

Eligibility

 Yes No Not Sure

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
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