This is a randomized, placebo-controlled trial with a cross-over component. It investigates the effect of non-invasive acupoint stimulation on stress in young and middle-aged women. A total of 90 participants will be enrolled: 60 with a Liver-Qi Stagnation constitution and high perceived stress, and 30 without this constitution as a non-intervention baseline control. The 60 participants with the target constitution will be randomized into two groups. One group (n=30) will undergo a cross-over intervention, sequentially receiving steam-warm acupressure and simple acupressure (at five acupoints) in a randomized order, separated by a washout period. The other group (n=30) will receive placebo stimulation. The primary outcome is the change in the Perceived Stress Scale (PSS-14) score. Secondary outcomes include physiological stress responses.
Female, aged 20-40 years.
Regular daily routine with relatively fixed wake-up and bedtimes, sufficient sleep (7-9 hours), regular diet, moderate physical activity, and avoidance of shift work.
Intact structure of major organ systems, with no active diseases or pathological damage.
Regular menstrual cycle (21-35 days) and normal menstrual period (3-7 days).
Participation in any other clinical trial evaluation within the past 1 month.
Presence of organic diseases, such as various malignant tumors, certain chronic diseases (heart disease, diabetes, anemia, etc.), certain gynecological diseases (uterine fibroids, endometriosis, severe mammary hyperplasia, etc.), or certain endocrine diseases (hyperthyroidism or hypothyroidism, etc.).
Individuals with hypothalamic-pituitary-adrenal (HPA) axis dysfunction, such as those with endocrine diseases (e.g., hyper/hypothyroidism, Cushing's syndrome, congenital adrenal hyperplasia, primary chronic adrenocortical insufficiency).
Individuals diagnosed with major depressive disorder or anxiety disorder, bipolar disorder, schizophrenia, etc.
Parallel
Non-invasive Steam-warm Acupoint Stimulation
Other interventionParticipants will use a self-use device to apply steam-warm acupoint stimulation at five acupoints (GV20/Baihui, PC6/Neiguan, LI4/Hegu, SP6/Sanyinjiao, LR3/Taichong). The device consists of a main body (Part A) containing a heating element and high-hardness non-woven protrusions, secured by a adjustable strap (Part B). Stimulation is applied for 20 minutes per session, 3 times per week.
Non-invasive Pressure Acupoint Stimulation
Other interventionParticipants will use a self-use device to apply pressure-only acupoint stimulation at the same five acupoints as above. The device is visually similar to the steam-warm device but Part A contains a non-heating, shaped hard sheet and high-hardness non-woven protrusions. It is secured by the same adjustable strap (Part B). Stimulation is applied for 20 minutes per session, 3 times per week.
Placebo Acupoint Stimulation
Other interventionParticipants will use a self-use device designed to mimic the active intervention devices in appearance. The device's Part A contains a non-heating, shaped hard sheet and low-hardness non-woven protrusions that deliver minimal pressure, secured by the same adjustable strap (Part B). It is applied to the same five acupoints for 20 minutes per session, 3 times per week.
Change in Perceived Stress Scale (PSS-14) Score
Change in Heart Rate Variability (HRV) Parameters during Acute Stress
Change in Psychophysiological Response to the Montreal Imaging Stress Task (MIST)
Change in Salivary Cortisol and 3-Methoxy-4-hydroxyphenylglycol (MHPG) Levels during Acute Stress
Change in Medial Prefrontal Cortex (mPFC) Activation during Acute Stress measured by fNIRS
Change in Subjective Pressure Level measured by Visual Analogue Scale (VAS)
Change in Sleep Quality measured by Pittsburgh Sleep Quality Index (PSQI)
Change in Depression Symptoms measured by Self-Rating Depression Scale (SDS)
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