Shanghai China-norm Quality Technical Service Co., Ltd., Shanghai, Shanghai 200072
Shanghai, China
NCT Number: NCT07508748
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.
Trial opening soon.
Get Notified20 year–40 year
Female
Interventional
Not applicable
Shanghai, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: From Baseline (Visit 1) to the end of each 4-week intervention phase (Visit 2 and, for the crossover group, Visit 4).
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).
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).
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.
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).
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).
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).
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).
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).
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).
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).
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).
Contact information is provided by the study sponsor or research team.
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