An interventional study of Compression band with vaccaria seeds and Compression band only in Primary Dysmenorrhea (PD), sponsored by China Medical University Hospital. Recruiting at 1 site in Taiwan. Open to female participants aged 20 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by China Medical University Hospital · Not applicable, Interventional, and Treatment
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.
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.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's planned enrollment of 30 is below the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →China Medical University Hospital is the lead sponsor of 479 studies on the registry; 115 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will wear the compression band only, without Vaccaria seeds, and apply the band to the same location to serve as a control.
Device: Compression band only
Participants will wear a compression band combined with vaccaria seeds applied to the Sanyinjiao (SP6) acupoint to receive continuous acupressure stimulation during menstruation.
Device: Compression band with vaccaria seeds
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.
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.
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.
Time frame: From baseline (Cycle 1) through the end of the third intervention menstrual cycle (Cycle 4); menstrual cycle length is 21-35 days.
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.
Time frame: At baseline (Cycle 1) and at the end of the third intervention menstrual cycle (Cycle 4); menstrual cycle length is 21-35 days.
Change from Baseline in Heart Rate Variability (HRV) Measures
Heart rate variability (HRV) will be assessed using the ANS Watch as an auxiliary measure of autonomic nervous system activity. The high-frequency (HF) and low-frequency (LF) components will be evaluated before and after the intervention.
Time frame: On the third day of menstruation during the baseline menstrual cycle (Cycle 1) and during the third intervention menstrual cycle (Cycle 4); menstrual cycle length is 21-35 days.
Plan to share: 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.
Start is estimated for Sep 2026; primary completion for Aug 2027, 11 months later.
Of 178 non-industry interventional studies with no phase under Dysmenorrhea, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's planned 11 months is above that.
Counting every sponsor, half of 188 studies reached it within 8 months; a quarter within 3 and three quarters within 16.
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