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Primary Dysmenorrhea (PD)NCT07794995

Effectiveness of an Acupressure Band for Primary Dysmenorrhea in College Students

A study testing Compression band with vaccaria seeds and Compression band only in people with Primary Dysmenorrhea (PD), run by China Medical University Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to investigate the effectiveness of an acupressure band in improving primary dysmenorrhea among college students. Primary dysmenorrhea is characterized by cramping lower abdominal pain during menstruation and is often accompanied by symptoms such as nausea, fatigue, and headache. Read more about this study

Who is it for?
Ages 20 to 24 years, women only
Conditions the study is for
Primary Dysmenorrhea (PD)
What is being tested?
Compression band with vaccaria seeds and Compression band only
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteTaiwan
Study dates
1 Sep 2026to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 20 to 24 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female university students aged 20 to 24 years.
  • Diagnosed with primary dysmenorrhea and having a Visual Analog Scale (VAS) pain score of 3 or higher.
  • Regular menstrual cycles ranging from 21 to 35 days.
  • Menstrual duration ranging from 4 to 10 days.

Who cannot join

  • Known history of secondary dysmenorrhea, including endometriosis or uterine fibroids.
  • Chronic medical disease or psychiatric disease.
  • Current smoking.
  • Pregnancy.
  • Long-term use of oral contraceptives or presence of an intrauterine device.
  • Significant lower-extremity pitting edema, abnormal lower-extremity circulation, marked swelling, skin damage, infection, sensory abnormalities, or other conditions considered unsuitable for wearing the acupressure band by the research staff.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site, 1 recruiting
  • China Medical University Hospital

    Taichung, Taichung City, 404327

    Yu-Chen Lee, 886975682023, 005167@tool.caaumed.org.tw

    springsnowflake2004@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: Effectiveness of an Acupressure Band for Primary Dysmenorrhea in College Students: A Randomized Controlled Trial

This study aims to investigate the effectiveness of an acupressure band in improving primary dysmenorrhea among college students. Primary dysmenorrhea is characterized by cramping lower abdominal pain during menstruation and is often accompanied by symptoms such as nausea, fatigue, and headache. It is also one of the leading causes of academic and work absenteeism among women of reproductive age. Previous studies have shown that acupressure applied to the Sanyinjiao (SP6) acupoint can alleviate menstrual pain. In addition, current clinical research has mainly focused on auricular acupressure using Vaccaria seeds, while relatively few studies have explored their application on body acupoints. Therefore, this study focuses on the application of Vaccaria seeds on the Sanyinjiao (SP6) acupoint to evaluate their effects on primary dysmenorrhea.

To provide continuous and stable acupoint stimulation, this study utilizes an intervention device combining Vaccaria seeds with a compression band, together with acupressure stimulation.

Read more

This study adopts a single-blind randomized controlled trial design. A total of 30 participants will be randomly assigned to either the experimental group or the control group (compression band only group). The study consists of four menstrual cycles, including one baseline menstrual cycle followed by three consecutive menstrual cycles of home-based intervention.

Outcome measures include the Visual Analog Scale (VAS) for pain intensity, the Menstrual Distress Questionnaire (MEDI-Q) for menstrual-related symptoms and distress, and heart rate variability (HRV), monitored using the ANS Watch as an indicator of autonomic nervous system activity. Statistical analyses will be conducted to compare differences between the experimental and control groups, as well as between pre- and post-intervention measurements, in order to evaluate the clinical potential of the acupressure band for primary dysmenorrhea management.

Being tested
Compression band with vaccaria seeds, Compression band only
Keywords
Sanyinjiao (SP6), Acupressure

What participants receive

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

  • Compression band with vaccaria seedsDevice

    The intervention utilizes an adjustable band with three Vaccaria seeds forming a 5 mm circular stimulation area, designed to cover the Sanyinjiao (SP6) acupoint region. The seeds are fixed on the inner side of the band. In the first session, a medical student research assistant trained in acupuncture will teach the participant how to locate the SP6 acupoint (3 cun or 4 finger-widths above the tip of the medial malleolus, at the posterior border of the tibia). For subsequent home-based intervention, participants will locate and apply the band by themselves. The band consists of 60% non-elastic and 40% elastic materials with a 3 cm velcro buffer.

  • Compression band onlyDevice

    The control group utilizes the same adjustable band design but without any Vaccaria seeds on the inner side. In the first session, a medical student research assistant will guide the participant to locate the Sanyinjiao (SP6) region on the calf for standardization. Participants will wear and apply the band by themselves at home following the same instructions. The band consists of 60% non-elastic and 40% elastic materials, with a 3-cm Velcro buffer.

Study groups in NCT07794995
Study groupRoleWhat they receive
Compression Band OnlySham comparatorParticipants will wear the compression band only, without Vaccaria seeds, and apply the band to the same location to serve as a control.
Receives: Device: Compression band only
Compression Band with Vaccaria SeedsExperimentalParticipants will wear a compression band combined with vaccaria seeds applied to the Sanyinjiao (SP6) acupoint to receive continuous acupressure stimulation during menstruation.
Receives: Device: Compression band with vaccaria seeds

What is being measured

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

  1. Change from Baseline in Average Menstrual Pain Intensity Measured by the Visual Analog Scale (VAS)

    Menstrual pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain). During each menstrual period, participants will record their average and maximum pain intensity each evening. The average menstrual pain intensity for each menstrual cycle will be calculated from the daily VAS records and used for the primary outcome analysis.

    Measured: From baseline (Cycle 1) through the end of the third intervention menstrual cycle (Cycle 4); menstrual cycle length is 21-35 days.

Secondary outcomes (1)
  1. Change from Baseline in Menstrual Distress Questionnaire (MEDI-Q) Total Score

    Menstrual-related symptoms and distress will be assessed using the Menstrual Distress Questionnaire (MEDI-Q). The questionnaire includes 25 items assessing physical and psychological symptoms associated with menstruation. The MEDI-Q Total Score is calculated by summing the scores of all 25 items, with a possible range from 0 to 125, with higher scores indicating greater menstrual distress. For this study, the recall period will be modified from the previous year to the previous three months to correspond with the intervention period. Change in the MEDI-Q Total Score from baseline to the end of the intervention will be evaluated.

    Measured: At baseline (Cycle 1) and at the end of the third intervention menstrual cycle (Cycle 4); menstrual cycle length is 21-35 days.

Timeline

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

  1. First posted31 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07794995
Sponsor's protocol ID
CMUH115-REC1-119
Other IDs
115-2813-C-039 -125 -B
Status last verified
Aug 2026
First submitted
22 Aug 2026
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with other researchers because the study protocol does not include a plan for sharing individual participant data. Study data will be coded and stored in an offline, non-networked folder for five years and will be destroyed after the retention period.

Publications

  • Wu, C. Y., Wu, J. H. C., Lin, Y. C., & Chen, C. H. (2020). The Efficacy of Auriculotherapy for Dysmenorrhea: Systematic Review and Meta-Analysis. Journal of Chinese Medicine, 31(1), 4-19. https://doi.org/10.6940/JCM.202006_31(1).02

  • Chien, T. J., Huang, Y. S., Kuo, C. Y., Cho, Y. C., Chen, H. Y., & Chu, C. C. (2024). Effects of the Number of Acupoint Stimulation on Autonomic Nervous Activity and Symptom Improvements in Dysmenorrhea-A Randomized Clinical Trial. Taipei City Medical Journal, 21(1), 45-64. https://doi.org/10.6200/TCMJ.202403_21(1).0005

  • Anggraini, Y., Islamiyati, Sumiyati, & Ekawati, I. W. (2020). Acupressure therapy as a pain reliever for dysmenorrhea. Enfermería Clínica, 30(Suppl. 5), 84-87. https://doi.org/10.1016/j.enfcli.2019.11.027

  • Gao, J. X., & Xia, Y. (1997). Body acupoint sticking therapy in the treatment of anorexia in children. Abstracts of World Integrated Medicine Congress, October 1997, p. 331.

  • Chen, J. (2009). Application of magnetic bead acupoint pressing in patients with postoperative intestinal flatulence after surgery. Journal of Emergency in Traditional Chinese Medicine, 18(5), 835-836.

  • Liu W, Towell-Barnard A, Lee KH, Kang TL. Attitudes and expectations towards acupuncture for primary dysmenorrhoea: Findings from a cross-sectional survey in Australia. Acupunct Med. 2026 Jul 4:9645284261458839. doi: 10.1177/09645284261458839. Online ahead of print.

    PubMed 42400452
  • Sawai A, Tochigi Y, Kavaliova N, Zaboronok A, Warashina Y, Mathis BJ, Mesaki N, Shiraki H, Watanabe K. MRI reveals menstrually-related muscle edema that negatively affects athletic agility in young women. PLoS One. 2018 Jan 24;13(1):e0191022. doi: 10.1371/journal.pone.0191022. eCollection 2018.

    PubMed 29364948
  • Krijnen RM, de Boer EM, Ader HJ, Bruynzeel DP. Diurnal volume changes of the lower legs in healthy males with a profession that requires standing. Skin Res Technol. 1998 Feb;4(1):18-23. doi: 10.1111/j.1600-0846.1998.tb00080.x.

    PubMed 27331844
  • Cassioli E, Rossi E, Melani G, Faldi M, Rellini AH, Wyatt RB, Oester C, Vannuccini S, Petraglia F, Ricca V, Castellini G. The menstrual distress questionnaire (MEDI-Q): reliability and validity of the English version. Gynecol Endocrinol. 2023 Jun 19;39(1):2227275. doi: 10.1080/09513590.2023.2227275.

    PubMed 37356456
  • Rimaud D, Convert R, Calmels P. In vivo measurement of compression bandage interface pressures: the first study. Ann Phys Rehabil Med. 2014 Aug-Sep;57(6-7):394-408. doi: 10.1016/j.rehab.2014.06.005. Epub 2014 Jun 26.

    PubMed 25193773
  • Wang YJ, Hsu CC, Yeh ML, Lin JG. Auricular acupressure to improve menstrual pain and menstrual distress and heart rate variability for primary dysmenorrhea in youth with stress. Evid Based Complement Alternat Med. 2013;2013:138537. doi: 10.1155/2013/138537. Epub 2013 Dec 12.

    PubMed 24416063
  • Chien TJ, Huang YS, Liao LL, Chu CC, Pai JH. Head-to-Head Comparison of Electroacupuncture and Laser Acupuncture Effects on Autonomic Regulation and Clinical Effects in Dysmenorrhea: A Randomized Crossover Clinical Trial. J Integr Complement Med. 2024 Jun;30(6):560-575. doi: 10.1089/jicm.2023.0183. Epub 2024 Feb 16.

    PubMed 38364185
  • Zhai S, Wang C, Ruan Y, Liu Y, Ma R, Fang F, Zhou Q. Wrist-ankle acupuncture for primary dysmenorrhea: a randomized controlled trial evaluating the efficacy of an analgesic strap. Front Neurol. 2024 May 30;15:1362586. doi: 10.3389/fneur.2024.1362586. eCollection 2024.

    PubMed 38872824
  • Allais G, Rolando S, Castagnoli Gabellari I, Burzio C, Airola G, Borgogno P, Schiapparelli P, Allais R, Benedetto C. Acupressure in the control of migraine-associated nausea. Neurol Sci. 2012 May;33 Suppl 1(Suppl 1):S207-10. doi: 10.1007/s10072-012-1069-y.

    PubMed 22644205
  • Bumgarner JR, McCray EW, Nelson RJ. The disruptive relationship among circadian rhythms, pain, and opioids. Front Neurosci. 2023 Feb 15;17:1109480. doi: 10.3389/fnins.2023.1109480. eCollection 2023.

    PubMed 36875657

Questions about this trial

What is this clinical trial studying?

A study testing Compression band with vaccaria seeds and Compression band only in people with Primary Dysmenorrhea (PD), run by China Medical University Hospital at 1 site in Taiwan.

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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 31 Aug 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 Taiwan. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ya-Jhen Chen (886932518723, springsnowflake2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Average Menstrual Pain Intensity Measured by the Visual Analog Scale (VAS) (time frame: From baseline (Cycle 1) through the end of the third intervention menstrual cycle (Cycle 4); menstrual cycle length is 21-35 days.). 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 NCT07794995, which also lists 29 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 31 Aug 2026.

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