Primary Dysmenorrhea (PD)
Conditions
Keywords
Sanyinjiao (SP6), Acupressure
Brief 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. 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.
Interventions
DEVICECompression 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.
DEVICECompression band only
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.
Sponsors
China Medical University Hospital
National Science and Technology Council, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Average Menstrual Pain Intensity Measured by the Visual Analog Scale (VAS) | From baseline (Cycle 1) through the end of the third intervention menstrual cycle (Cycle 4); menstrual cycle length is 21-35 days. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Menstrual Distress Questionnaire (MEDI-Q) Total Score | At baseline (Cycle 1) and at the end of the third intervention menstrual cycle (Cycle 4); menstrual cycle length is 21-35 days. | 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. |
Countries
Taiwan
Contacts
CONTACTYa-Jhen Chen
Outcome results
None listed