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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steam-warm and Simple Acupressure Crossover Group | Other | Non-invasive acupoint stimulation |
|
| Placebo Control | Other |
| |
| Healthy Baseline Control (No Intervention) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive Steam-warm Acupoint Stimulation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Perceived Stress Scale (PSS-14) Score | From Baseline (Visit 1) to the end of each 4-week intervention phase (Visit 2 and, for the crossover group, Visit 4). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Heart Rate Variability (HRV) Parameters during Acute Stress | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Medial Prefrontal Cortex (mPFC) Activation during Acute Stress measured by fNIRS | 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 Subjective Pressure Level measured by Visual Analogue Scale (VAS) |
Inclusion Criteria:
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):
For the control group (non-Qi Yu constitution group):
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanwen Jiang | Contact | 13501700841 | jiangyanwen@china-norm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072 | Shanghai | China |
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|
| Non-invasive Pressure Acupoint Stimulation | Other | 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. |
|
| Placebo Acupoint Stimulation | Other | 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. |
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| 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 | 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. |
| Assessed at multiple time points 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 Sleep Quality measured by Pittsburgh Sleep Quality Index (PSQI) | At Baseline (Week 0), after the first 4-week intervention (Week 4), after the 3-week washout (Week 7), and after the second 4-week intervention (Week 11, for the crossover group). |
| Change in Depression Symptoms measured by Self-Rating Depression Scale (SDS) | At Baseline (Week 0), after the first 4-week intervention (Week 4), after the 3-week washout (Week 7), and after the second 4-week intervention (Week 11, for the crossover group). |
| Change in Self-Rating Anxiety Scale (SAS) Score | From Baseline (Week 0) to the end of the first 4-week intervention (Week 4), and for the crossover group also to the end of the second 4-week intervention (Week 11). Also assessed after the 3-week washout (Week 7). |
| Change in Sub-Health Measurement Scale Version 1.0 (SHMS V1.0) Score | From Baseline (Week 0) to the end of the first 4-week intervention (Week 4), and for the crossover group also to the end of the second 4-week intervention (Week 11). Also assessed after the 3-week washout (Week 7). |
| Change in Health Status Questionnaire (Qi Yu Constitution) Score | From Baseline (Week 0) to the end of the first 4-week intervention (Week 4), and for the crossover group also to the end of the second 4-week intervention (Week 11). Also assessed after the 3-week washout (Week 7). |
| Change in University of California, Los Angeles Loneliness Scale (UCLA) Score | From Baseline (Week 0) to the end of the first 4-week intervention (Week 4), and for the crossover group also to the end of the second 4-week intervention (Week 11). Also assessed after the 3-week washout (Week 7). |