Auricular Acupressure for Premenstrual Syndrome in Female Students

University of Medicine and Pharmacy at Ho Chi Minh City

Status: Completed

Conditions: Premenstrual Syndrome

Treatments: Other: Lifestyle modifications; Other: Sham auricular acupressure therapy; Other: Auricular acupressure therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06981533

30.000.000 VND (Other Grant/Funding Number)

4259/QĐ-ĐHYD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Auricular acupressure therapy + Lifestyle modifications

Experimental group

Description:

Auricular acupressure therapy once a week on one ear for a total of 8 weeks (8 sessions), with treatment alternating between the two ears. Lifestyle modifications were followed according to the guidelines of the Royal College of Obstetricians and Gynaecologists (RCOG 2017) on PMS management.

Treatment:

Other: Auricular acupressure therapy

Other: Lifestyle modifications

Sham auricular acupressure therapy + Lifestyle modifications

Sham Comparator group

Description:

Sham auricular acupressure once a week on one ear for a total of 8 weeks (8 sessions), with treatment alternating between the two ears. Lifestyle modifications were followed according to the guidelines of the Royal College of Obstetricians and Gynaecologists (RCOG 2017) on PMS management.

Treatment:

Other: Sham auricular acupressure therapy

Other: Lifestyle modifications