A Study on the Effects and Mechanisms of Non-invasive Acupoint Stimulation in Intervening in High Stress Sensitivity Among Young and Middle-aged Women With Qi Stagnation Constitution

Обзор

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.

Вмешательства

• Другое Non-invasive Steam-warm Acupoint Stimulation
  Participants 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.
• Другое Non-invasive Pressure Acupoint Stimulation
  Participants 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.
• Другое Placebo Acupoint Stimulation
  Participants 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.

Первичные конечные точки

• Change in Perceived Stress Scale (PSS-14) Score [Срок оценки: From Baseline (Visit 1) to the end of each 4-week intervention phase (Visit 2 and, for the crossover group, Visit 4).]

Вторичные конечные точки (3)

• Change in Heart Rate Variability (HRV) Parameters during Acute Stress [Срок оценки: During each standardized acute stress task (MIST) conducted at Baseline (Week 0), after the first 4-week intervention (Week 4), and after the second 4-week intervention (Week 11, for the crossover group).]
• Change in Psychophysiological Response to the Montreal Imaging Stress Task (MIST) [Срок оценки: During each standardized acute stress task (MIST) conducted at Baseline (Week 0), after the first 4-week intervention (Week 4), and after the second 4-week intervention (Week 11, for the crossover group).]
• Change in Salivary Cortisol and 3-Methoxy-4-hydroxyphenylglycol (MHPG) Levels during Acute Stress [Срок оценки: Saliva samples are collected at multiple timepoints (T0, T15, T20, T25, T30 minutes) during each standardized acute stress task (MIST) conducted at Baseline (Week 0), after the first 4-week intervention (Week 4), and after the second 4-week intervention.]

Критерии участия

Критерии включения

• 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).
• For the experimental group (Qi Yu constitution group):

• Perceived Stress Scale (PSS-14) score ≥ 43.
• Qi Yu Constitution Subscale score ≥ 40.
• Diagnosis by a qualified TCM physician according to standard procedures, confirming characteristics of Qi Yu constitution, including (physical symptoms partially required):

• Body type: Tending to be thin.
• Psychological characteristics: Introverted, unstable, sensitive, suspicious, with significant emotional fluctuations.
• Somatic symptoms: Fullness or migrating pain in the chest and hypochondrium, frequent sighing; sensation of a foreign body in the throat (globus hystericus); sleep disturbances (difficulty falling asleep, early awakening). Poor appetite, frequent belching.
• Tongue and pulse: Pale red tongue with thin white coating, wiry and thin pulse.
• For the control group (non-Qi Yu constitution group):

• Perceived Stress Scale (PSS-14) score ≤ 42.
• Qi Yu Constitution Subscale score < 30.
• No relevant clinical manifestations upon TCM examination.
• Signed informed consent form, voluntarily participating in the trial.
• Willing to comply with all testing requirements.
• No infection or bleeding tendency on the skin of the five acupoint areas (GV20/Baihui, LI4/Hegu, LR3/Taichong, PC6/Neiguan, SP6/Sanyinjiao), not affecting the use of the study products.

Критерии исключения

• 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.
• Use of antidepressants, anti-anxiety medications, glucocorticoids, or immunosuppressants within the past 4 weeks.
• Recent (within the past 3 months) suicidal ideation or self-harm behavior.
• Receipt of acupuncture, massage, or other TCM treatments or psychological interventions (e.g., cognitive behavioral therapy) within the past 4 weeks.
• Suffering from autoimmune diseases requiring long-term use of hormones.
• Alcohol or drug dependence.
• Experienced major stressful life events (e.g., bereavement of a close relative suffering a major psychological blow) in the past year.
• Physically weak or unable to tolerate the arithmetic stress in the MIST task.
• Conditions such as epilepsy, hypertension, or heart disease that are unsuitable for undergoing induced psychological stress.
• Inability to cooperate in completing the MIST task (e.g., due to visual/auditory impairment, cognitive dysfunction).
• Inability or unwillingness to attend all study visits and comply with the treatment regimen.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072 — Шанхай

Идентификаторы

NCT: NCT07508748 · C25023004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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