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Premenstrual SyndromeNCT06981533

Auricular Acupressure for Premenstrual Syndrome in Female Students

A study testing Auricular acupressure therapy and Lifestyle modifications in people with Premenstrual Syndrome, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 25 years, women only
Conditions the study is for
Premenstrual Syndrome
What is being tested?
Auricular acupressure therapy and Lifestyle modifications
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteVietnam
Study dates
20 Apr 2025to 30 Sep 2025
Phase
Interventional
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
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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 locations and contacts

1 site in 1 country.

Vietnam1 site
  • Faculty of Traditional medicine - University of Medicine and Pharmacy at Ho Chi Minh City

    Ho Chi Minh City, Ho Chi Minh City, 700000

Other trials in Vietnam

About this study

Official title: Efficacy of Auricular Acupressure in Treating Premenstrual Syndrome in Female Undergraduate Students

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:

Read more
  • 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.

Being tested
Auricular acupressure therapy, Sham auricular acupressure therapy, Lifestyle modifications
Keywords
Premenstrual Syndrome, Auricular Acupressure, Female undergraduate students, PMS, The Premenstrual Symptoms Screening Tool
Medical subject headings
Premenstrual Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Auricular acupressure therapyOther

    Also called Auricular Acupressure, Ear Acupressure

    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.

  • Sham auricular acupressure therapyOther

    Also called Sham Ear Acupressure

    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.

  • Lifestyle modificationsOther

    Also called Lifestyle changes

    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.

Study groups in NCT06981533
Study groupRoleWhat they receive
Auricular acupressure therapy + Lifestyle modificationsExperimentalAuricular 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.
Receives: Other: Auricular acupressure therapy; Other: Lifestyle modifications
Sham auricular acupressure therapy + Lifestyle modificationsSham comparatorSham 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.
Receives: Other: Sham auricular acupressure therapy; Other: Lifestyle modifications

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

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

Secondary outcomes (1)
  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.

    Measured: Through study completion, an average of 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2025
  2. Study start20 Apr 2025
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized, single-blind, parallel controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06981533
Sponsor's protocol ID
4259/QĐ-ĐHYD
Other IDs
30.000.000 VND
Status last verified
Jun 2026
First submitted
3 May 2025
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

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

Questions about this trial

What is this clinical trial studying?

A study testing Auricular acupressure therapy and Lifestyle modifications in people with Premenstrual Syndrome, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.

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 8 inclusion and 11 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 9 Jun 2026. 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 Vietnam. 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. Some participants in this study may receive a placebo. 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?

The change in PSST scores (time frame: From baseline to 1 week and to the end of treatment at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06981533, which also lists 5 linked publications.

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 9 Jun 2026.

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