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CompletedNCT06981533Updated Jun 9, 2026

Auricular Acupressure for Premenstrual Syndrome in Female Students

An interventional study of Auricular acupressure therapy and Sham auricular acupressure therapy in Premenstrual Syndrome, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Completed at 1 site in Vietnam. Open to female participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
Female
01

Study 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.
Read the detailed 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.

02

Conditions studied

  • Premenstrual Syndrome

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Keywords

  • Premenstrual Syndrome
  • Auricular Acupressure
  • Female undergraduate students
  • PMS
  • The Premenstrual Symptoms Screening Tool
03

In context

Premenstrual Syndrome

177 studies on the registry are indexed under Premenstrual Syndrome; 30 are open to participants now.

This study's enrollment of 66 is close to the median of 70 across 153 interventional studies indexed under Premenstrual Syndrome.

Browse Premenstrual Syndrome studies →

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 118 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Auricular acupressure therapy + Lifestyle modifications

    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.

    Other: Auricular acupressure therapy · Other: Lifestyle modifications

  • Sham comparator
    Sham auricular acupressure therapy + Lifestyle modifications

    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.

    Other: Sham auricular acupressure therapy · Other: Lifestyle modifications

Interventions

  • OtherAuricular acupressure therapy

    Auricular acupressure will be performed 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 on one ear, with treatment administered once a week, alternating between the left and right ears. In total, auricular acupressure was applied 8 times over a period of 8 weeks. The first treatment session occurred 5-7 days prior to the onset of menstruation. Participants were instructed to perform acupressure at the acupoint sites three times daily-morning, noon, and evening-pressing each point for 1 minute per session.

    Also known as: Auricular Acupressure, Ear Acupressure

  • OtherSham auricular acupressure therapy

    Sham auricular acupressure therapy will be performed using similarly sized adhesive patches without seeds, applied to the same acupoint locations as in the intervention group. The procedure steps and the duration of the trial were the same as in the auricular acupressure group.

    Also known as: Sham Ear Acupressure

  • OtherLifestyle modifications

    Lifestyle modifications will be followed according to the "Guidelines for the Management of Premenstrual Syndrome" by the Royal College of Obstetricians and Gynaecologists (RCOG), which will include: Regular moderate exercise (such as walking, yoga, or swimming), stress reduction, and ensuring quality sleep (7-8 hours per night); Reducing intake of salt, sugar, and foods containing saturated fats; Increasing intake of high-fiber foods such as fruits and vegetables; Avoiding smoking, and limiting alcohol, and other stimulants.

    Also known as: Lifestyle changes

06

What researchers measure

Primary outcomes

  1. The change in PSST scores

    This is a quantitative variable, with the unit being score. Scoring is done by asking participants based on the Premenstrual Symptoms Screening Tool (PSST) with 19 items. Each item is scored according to the Likert-4 scale, and the total score from the 19 items represents the overall PMS symptom score.

    Time frame: From baseline to 1 week and to the end of treatment at 8 weeks

  2. The change in WHOQOL-Bref scores

    This is a quantitative variable, with the unit being points. The scoring is done by asking participants 26 questions to assess various domains of quality of life, including Physical Health, Psychological, Social Relationships, and Environment. Responses are categorized based on the Likert-5 scale. The average score for each domain is converted to a 100-point scale.

    Time frame: From baseline to 1 week and to the end of treatment at 8 weeks

Secondary outcomes

  1. Adverse effects

    Adverse effects occurring during the treatment and follow-up periods, regardless of their association with the interventions, will be recorded and managed with appropriate measures.

    Time frame: Through study completion, an average of 8 weeks

07

Study locations

1 site
  • Faculty of Traditional medicine - University of Medicine and Pharmacy at Ho Chi Minh City
    Ho Chi Minh City, Ho Chi Minh City 700000, Vietnam
08

References and documents

Publications

  • Korelo RIG, Moreira NB, Miguel BAC, Cruz CGD, Souza NSP, Macedo RMB, Gallo RBS. Effects of Auriculotherapy on treatment of women with premenstrual syndrome symptoms: A randomized, placebo-controlled clinical trial. Complement Ther Med. 2022 Jun;66:102816. doi: 10.1016/j.ctim.2022.102816. Epub 2022 Feb 12. PubMed 35167949 ↗
  • Koleini S, Valiani M. Comparing the Effect of Auriculotherapy and Vitamin B6 on the Symptoms of Premenstrual Syndrome among the Students who Lived in the Dorm of Isfahan University of Medical Sciences. Iran J Nurs Midwifery Res. 2017 Sep-Oct;22(5):354-358. doi: 10.4103/ijnmr.IJNMR_120_16. PubMed 29033988 ↗
  • Jang SH, Kim DI, Choi MS. Effects and treatment methods of acupuncture and herbal medicine for premenstrual syndrome/premenstrual dysphoric disorder: systematic review. BMC Complement Altern Med. 2014 Jan 10;14:11. doi: 10.1186/1472-6882-14-11. PubMed 24410911 ↗
  • Zhang J, Cao L, Wang Y, Jin Y, Xiao X, Zhang Q. Acupuncture for Premenstrual Syndrome at Different Intervention Time: A Systemic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2019 Jun 25;2019:6246285. doi: 10.1155/2019/6246285. eCollection 2019. PubMed 31341497 ↗
  • Armour M, Ee CC, Hao J, Wilson TM, Yao SS, Smith CA. Acupuncture and acupressure for premenstrual syndrome. Cochrane Database Syst Rev. 2018 Aug 14;8(8):CD005290. doi: 10.1002/14651858.CD005290.pub2. PubMed 30105749 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06981533
Lead sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Responsible party
Le Nguyen Thanh Vy (MD, University of Medicine and Pharmacy at Ho Chi Minh City) — Principal investigator
First posted
May 20, 2025
Start date
Apr 20, 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025
Last update
Jun 9, 2026

Study contacts

Deputy principal
study chair · University of Medicine and Pharmacy at Ho Chi Minh City

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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