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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acupoints; Qi Stagnation Constitution
• Intervention / Treatment: Other: Non-invasive Steam-warm Acupoint Stimulation; Other: Non-invasive Pressure Acupoint Stimulation; Other: Placebo Acupoint Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanwen Jiang; Phone Number: 13501700841; Email: jiangyanwen@china-norm.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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):

    • 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Steam-warm and Simple Acupressure Crossover Group; Non-invasive acupoint stimulation	Other: 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.; Other: 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.
Other: Placebo Control	Other: 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.
No Intervention: Healthy Baseline Control (No Intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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)	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.

Other Outcome Measures

Outcome Measure	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)	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).

Collaborators and Investigators

• Sponsor: ChinaNorm

Study record dates

Study Major Dates

• Study Start (Estimated): April 7, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: C25023004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No