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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorChinaNorm

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Non-invasive Steam-warm Acupoint Stimulation
  • Non-invasive Pressure Acupoint Stimulation
  • Placebo Acupoint Stimulation

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators