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NOT YET RECRUITING
NCT07508748
NA

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

Sponsor: ChinaNorm

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

20 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-04-07

Completion Date

2026-07-30

Last Updated

2026-04-02

Healthy Volunteers

Yes

Interventions

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 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.

Locations (1)

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

Shanghai, China