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| ID | Type | Description | Link |
|---|---|---|---|
| ZH3P | Other Grant/Funding Number | the Bright Future Charitable Fund |
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Background: Mental disorders are recognized as a major cause of disability and disease burden across the lifespan. Gua Sha is believed to improve mental health and sleep quality significantly. Tui Jing is an innovative type of Gua Sha therapy that penetrates deep into the muscles and fascia rather than just acting on the surface of the skin. Modern research has revealed that Gua Sha is extensively utilized for pain-related symptoms, and its therapeutic effects may be attributed to anti-inflammatory and immunomodulatory mechanisms. Although Gua Sha has demonstrated efficacy in treating various diseases, limited research exists regarding its impact and underlying mechanisms on mental health. This study will conduct a clinical trial to assess the efficacy of Tuijing Therapy on mental health. Autonomic function is closely associated with psychological symptoms, and HRV reflects the activation of the vagus nerve. This study aims to obtain preliminary evidence that Gua Sha can modulate HRV by regulating vagal function, potentially ameliorating psychological disorders. Population: The sample size is estimated using G*power, and a total of 64 participants are needed. Adults without any chronic diseases who score over 14 on the HAM-D 17 and have no smoking or drinking habits will be included. Method: A randomized controlled study will be conducted with Tuijing therapy as the intervention and sham therapy as the control. The intervention group will receive the actual intervention, while the sham intervention group will undergo a sham ultrasound treatment process that does not involve the active therapeutic components. A computer-generated random allocation schedule will be compiled before commencement by a researcher not involved in recruiting participants. Tuijing therapy will be administered as arm A, while the sham control group will serve as arm B. There will be a 5-day interval between interventions. Participants in arm B will receive 4 sessions of sham ultrasound therapy, with 45 minutes for 1 month. Participants in arm A will receive 4 sessions of Tui Jing therapy for 45 minutes for 1 month. Heart rate variability, brain activity, skin reflection, pain perception, psychological symptoms, and sleep quality will be assessed as outcome measures. Outcomes: The primary outcomes of this study are the efficacy of Tui Jing therapy on depressive symptoms. As secondary outcomes, this study will assess changes in heart rate variability, brain activity, skin reflection, stress and anxiety symptoms, and sleep quality. Heart rate variability will be measured using a heart rate variability monitoring device, and brain activity will be measured by fNIRS. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Stress and anxiety symptoms will be evaluated using the Depression Anxiety Stress Scales (DASS).
Procedures: The researcher will conduct an initial telephone interview to provide study information and screen potential participants for eligibility. Each participant will receive full details about the study's purpose and will be required to sign an informed consent form. All participants will be invited to two in-person sessions before accepting any intervention. In the first session, comprehensive medical histories, brief semi-structured interviews for psychological symptoms, clinical examinations, general information, and questionnaires will be conducted to determine eligibility. Eligible participants in the first session will be included in the second session. The second session will be scheduled to collect baseline data for further analysis. Eligible participants who meet the inclusion criteria will be randomly assigned to receive either Tui Jing therapy or sham stimulation. The intervention will be conducted by a qualified therapist (Registered Chinese Medicine Practitioner in Hong Kong) from the Department of Rehabilitation Sciences at PolyU, while another qualified researcher will be responsible for clinical interviews, screening, and data collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Tui Jing Group | Experimental | Tui Jing group: A standardized treatment protocol targeting specific meridians identified in traditional Chinese medicine will be followed. Designed specifically for psychological symptoms, the protocol involves bilateral therapy on four key meridians. These include the Hand Shaoyin Heart Meridian, Hand Jueyin Pericardium Meridian, Foot Taiyin Spleen Meridian, and Foot Jueyin Liver Meridian. |
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| The Sham ultrasound control | Sham Comparator | Participants will receive a sham ultrasound control on the same meridians. To enhance comfort and prevent cold sensations from the metal probe, the ultrasound device will be pre-warmed to body temperature. A gel, mimicking the texture of the lubricant used in Tui Jing therapy, will be applied. The device will mimic the motion, direction, duration, and frequency of the Tui Jing therapy, but without turning on the ultrasound's therapeutic mode. The participants will be informed that they are accepting low-intensity ultrasound mode, which will not produce any sensory perception, ensuring they cannot distinguish between the active and the sham interventions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| manual therapy: Tui Jing therapy | Other | (Gua Sha + Meridian pressure) was utilized, a specialized form of Gua Sha that incorporates traditional techniques with targeted pressure on specific meridians. |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological outcomes - Depression symptoms | Hamilton Depression Rating Scale (HAMD-17) Scale Range: 0-52 points Interpretation: Higher scores indicate greater depression severity Assessment: Semi-structured interview by trained raters Time Frame: Baseline, post-intervention, and two-week follow-up. | through study completion, an average of 12 months |
| Psychological outcomes - Depression symptoms | Patient Health Questionnaire (PHQ-9) Scale Range: 0-27 points Interpretation: Higher scores indicate greater depression severity Assessment: Self-administered questionnaire | through study completion, an average of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality | Pittsburgh Sleep Quality Index (PSQI) Scale Range: 0-21 points Interpretation: Higher scores indicate poorer sleep quality Assessment: Standardized self-report questionnaire | From the date of randomization until two weeks after the last treatment |
| Psychological outcomes - stress and anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yutong Li | Contact | 852 61917986 | zoeyo.li@connect.polyu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Recruiting | Hong Kong | Hung Hom | Hong Kong |
Confidentiality Agreement
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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A randomized controlled study will be conducted with Tui Jing therapy as the intervention and sham therapy as the control. The intervention group will receive the actual intervention, while the sham intervention group will undergo a sham ultrasound treatment process that does not involve the active therapeutic components. A computer-generated random allocation schedule will be compiled before commencement by a person not involved in the recruitment of participants. Tui Jing therapy will be administered as arm A, while the sham control group will serve as arm B. There will be a 5-day interval between interventions. Participants in arm B will receive 4 sessions of sham ultrasound therapy, with 45 minutes for 1 month.
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Screening and baseline assessments will precede the randomization process. Acomputerized program will generate a randomization sequence, assigning participants in a 1:1 ratio to active or sham stimulation. To ensure concealment, opaque sealed envelopes will be used, managed by a research assistant not involved in the direct handling of the study. While it is impossible to blind the therapist due to the intervention's nature, assessors will remain unaware of the treatment assignments. To evaluate the effectiveness of the blinding, participants and assessors will be asked two questions at the study's conclusion: "What type of treatment do you believe you/the participant received?" and "How confident are you that you received active stimulation?" The latter will be rated on a scale from 0 (no confidence) to 10 (very confident), aiming to measure their perceptions and confidence regarding thetreatment received.
| sham ultrasound intervention | Device | Participants will receive a sham ultrasound intervention on the same meridians. To enhance comfort and prevent cold sensations from the metal probe, the ultrasound device will be pre-warmed to body temperature. A gel, mimicking the texture of the lubricant used in Tui Jing therapy, will be applied. The device will mimic the motion, direction, duration, and frequency of the Tui Jing therapy, but without activating the ultrasound's therapeutic mode. The participants will be informed that they are accepting low-intensity ultrasound mode, which will not produce any sensory perception, ensuring in distinguishing ability between active and sham interventions |
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The Depression Anxiety Stress Scale (DASS) is a set of self-report questionnaires designed to measure the severity of negative emotional symptoms. Scale Range: 0-63 points. Interpretation: Higher scores indicate greater symptom severity. Anxiety: Normal (0-7), Mild (8-9), Moderate (10-14), Severe (15-19), Extremely Severe (20+). Stress: Normal (0-14), Mild (15-18), Moderate (19-25), Severe (26-33), Extremely Severe (34+) |
| From the date of randomization until two weeks after the last treatment |
| Sleep Efficiency | Objective Sleep Efficiency Measurement: (Total sleep time / Time in bed) × 100% Unit: Percentage (%). Tool: Fitbit Inspire 2 (FDA-cleared wearable device). Data Collection: Automated daily sync to the research platform. | From the date of randomization until two weeks after the last treatment |
| Subjective Sleep Quality and duration | Measurement: 10-point Likert scale (1 = "Very Poor", 10 = "Excellent") Unit: Scale score (1-10) Measurement: self-report sleep duration Tool: Standardized sleep diary | From the date of randomization until two weeks after the last treatment |
| Heart Rate Variability (HRV) | Metrics: RMSSD (Root Mean Square of Successive Differences), SDNN (Standard Deviation of NN Intervals), Low Frequency (LF: 0.04-0.15 Hz), High Frequency (HF: 0.15-0.40 Hz). Unit: Milliseconds (ms) Tool: NeXus-10 Biofeedback System (Mind Media) Protocol: 5-minute pre and post resting-state measurement; Task measurement (Cognitive neuroscience around 17 min); Synchronous measurement during intervention. | through study completion, an average of 12 months |
| Skin Reactions | Skin Discoloration Severity Measurement Protocol: Capture multispectral images using the IBOOLO DE-4100 system. Calculate the ΔContrast between affected and normal skin areas. Formula: ΔContrast = |Mean lesion chroma value - Mean normal skin chroma value|. Unit: Standardized chroma difference (0-100; 0=no difference, 100=maximal difference). Dimensionless relative units (a.u.) or standardized relative changes will be used. Quality Control: Imaging environment: Standardized D65 lighting, Analysis software: IBOOLO SkinAnalyzer Pro v3.2 | through study completion, an average of 12 months |
| Brain activity | Brain activity measurement: Human brain mapping using the NIRSport 2, a functional near-infrared spectroscopy (fNIRS) platform, is used to measure cerebral hemodynamics using a non-invasive method. This detection is determined by two types of near-infrared wavelength spectroscopy (NIRS). By reflecting near-infrared light off the cerebral tissue, information on tissue oxygenation and metabolism can be obtained. Tools : Specifications:
Protocol: 5-minute pre and post resting-state measurement; Task measurement (Cognitive neuroscience around 17 min); Synchronous measurement during intervention. | through study completion, an average of 12 months |