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Not yet recruitingNCT07508748Updated Apr 2, 2026

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

An interventional study of Non-invasive Steam-warm Acupoint Stimulation and Non-invasive Pressure Acupoint Stimulation in Qi Stagnation Constitution and Acupoints, sponsored by ChinaNorm. Not yet recruiting at 1 site in China. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by ChinaNorm · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Qi Stagnation Constitution
  • Acupoints
03

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Other
    Steam-warm and Simple Acupressure Crossover Group

    Non-invasive acupoint stimulation

    Other: Non-invasive Steam-warm Acupoint Stimulation · Other: Non-invasive Pressure Acupoint Stimulation

  • Other
    Placebo Control

    Other: Placebo Acupoint Stimulation

  • No intervention
    Healthy Baseline Control (No Intervention)

Interventions

  • OtherNon-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.

  • OtherNon-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.

  • OtherPlacebo 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.

05

What researchers measure

Primary outcomes

  1. Change in Perceived Stress Scale (PSS-14) Score

    Time frame: From Baseline (Visit 1) to the end of each 4-week intervention phase (Visit 2 and, for the crossover group, Visit 4).

Secondary outcomes

  1. Change in Heart Rate Variability (HRV) Parameters during Acute Stress

    Time frame: 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).

  2. Change in Psychophysiological Response to the Montreal Imaging Stress Task (MIST)

    Time frame: 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).

  3. Change in Salivary Cortisol and 3-Methoxy-4-hydroxyphenylglycol (MHPG) Levels during Acute Stress

    Time frame: 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 outcomes

  1. Change in Medial Prefrontal Cortex (mPFC) Activation during Acute Stress measured by fNIRS

    Time frame: 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).

  2. Change in Subjective Pressure Level measured by Visual Analogue Scale (VAS)

    Time frame: 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).

  3. Change in Sleep Quality measured by Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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).

  4. Change in Depression Symptoms measured by Self-Rating Depression Scale (SDS)

    Time frame: 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).

  5. Change in Self-Rating Anxiety Scale (SAS) Score

    Time frame: 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).

  6. Change in Sub-Health Measurement Scale Version 1.0 (SHMS V1.0) Score

    Time frame: 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).

  7. Change in Health Status Questionnaire (Qi Yu Constitution) Score

    Time frame: 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).

  8. Change in University of California, Los Angeles Loneliness Scale (UCLA) Score

    Time frame: 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).

06

Study locations

1 site
  • Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072
    Shanghai, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07508748
Lead sponsor
ChinaNorm
Responsible party
Sponsor
First posted
Apr 2, 2026
Start date
Apr 7, 2026 (estimated)
Primary completion
Jul 30, 2026 (estimated)
Completion
Jul 30, 2026 (estimated)
Last update
Apr 2, 2026

Study contacts

Yanwen Jiang
Contact
jiangyanwen@china-norm.com
13501700841

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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