Effects of Tuijing Therapy on Heart Rate Variability and Psychological Symptoms

Not Applicable

• Conditions: Depression

• Registration Number: NCT06888284
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

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 pilot 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 A formal sample size estimation is not required for pilot feasibility studies because the primary objective of this study is to assess feasibility and acceptance. The sample size is estimated according to a method for preliminary pilot study. The researchers aim to recruit 36 participants to assess the feasibility of the study. 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 pilot 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 complied with 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 6 times of sham ultrasound therapy with 30 minutes each session lasting 1 month. Participants in arm A will receive 6 times of Tui Jing therapy with 30 minutes each session lasting 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 feasibility, acceptance, and satisfaction. As secondary outcomes, this study will assess changes in heart rate variability, brain activity, skin reflection, pain perception, psychological symptoms, and sleep quality. Heart rate variability will be measured using a heart rate variability monitoring device, sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), and psychological symptoms will be evaluated using several related scales.

Detailed Description

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 for 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 meeting inclusion criteria will be randomly assigned to receive either Tui Jing therapy or sham stimulation. The intervention will be conducted by a qualified therapist (with a qualification in TCM \[Master's and Bachelor's degree in Traditional Chinese medicine\]) from the Department of Rehabilitation Sciences at PolyU, while another qualified researcher will be responsible for clinical interviews, screening, and data collection.

Study Timeline

• Study First Submitted: 2024-12-29
• Status Verified: 2025-03
• Study Start: 2025-03-10
• Study First Submitted QC: 2025-03-14
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-07-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age 18 - 55 years old
• Willingness to participate in the study and undergo randomization
• Proficiency in Chinese
• Absence of severe chronic diseases
• Experience with depression symptoms for over three months
• Scoring 20 or higher on the Montreal Cognitive Assessment (MoCA)
• Scoring above 14 on the Hamilton Depression Rating Scale 17

Exclusion Criteria

• The presence of cardiovascular disease (CVD)
• Severe head trauma, intracranial hypertension, implanted ferromagnetic devices, or a history of epilepsy
• Engagement in any pharmacological or non-pharmacological treatments within the past month
• Existing skin conditions or susceptibility to skin injuries
• Any form of cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment Satisfaction	through study completion, an average of 6 months	Treatment Satisfaction Score; Measurement: 10-point numerical rating scale (0 = "Completely Dissatisfied", 10 = "Fully Satisfied") Unit: Scale score (0-10) Tool: Standardized questionnaire
Intervention Liking Rate	through study completion, an average of 6 months	Intervention Liking Rate; Measurement: Binary response (Yes/No) Unit: Percentage (% "Yes" responses) Tool: Structured interview
Recommendation Willingness Rate	through study completion, an average of 6 months	Recommendation Willingness Rate; Measurement: Binary response (Yes/No) Unit: Percentage (% "Yes" responses) Tool: Structured interview
Eligibility Rate	through study completion, an average of 6 months	Eligibility Rate; Formula: (Number of eligible individuals / Total screened) × 100% Unit: Percentage (%) Data Source: Screening records
Recruitment Rate	through study completion, an average of 6 months	Recruitment Rate; Formula: (Number of consented participants / Eligible individuals) × 100% Unit: Percentage (%) Data Source: Recruitment database
Retention Rate	through study completion, an average of 6 months	Retention Rate; Formula: (Number of completers / Enrolled participants) × 100% Unit: Percentage (%) Data Source: Follow-up records
Adverse Event Rate	through study completion, an average of 6 months	Adverse Event Rate; Formula: (Participants reporting adverse events / Total participants) × 100% Unit: Percentage (%) Data Source: Adverse event report forms
Attrition Rate	through study completion, an average of 6 months	Attrition Rate; Formula: (Number of withdrawals / Enrolled participants) × 100% Unit: Percentage (%) Data Source: Withdrawal documentation
Adherence Rate	through study completion, an average of 6 months	Adherence Rate; Formula: (Days of full protocol adherence / Total intervention days) × 100% Unit: Percentage (%) Data Source: Intervention logs

Secondary Outcome Measures

Name	Time	Method
Sleep Efficiency	From date of randomization until two weeks after the last treatment	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
Subjective Sleep Quality	From date of randomization until two weeks after the last treatment	Measurement: 10-point Likert scale (1 = "Very Poor", 10 = "Excellent") Unit: Scale score (1-10) Tool: Standardized sleep diary
Skin Reactions	through study completion, an average of 6 months	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); Quality Control: Imaging environment: Standardized D65 lighting Analysis software: IBOOLO SkinAnalyzer Pro v3.2
Psychological outcomes - Depression symptoms	through study completion, an average of 6 months	Patient Health Questionnaire (PHQ-9); Scale Range: 0-27 points Interpretation: Higher scores indicate greater depression severity Assessment: Self-administered questionnaire
Sleep quality	From date of randomization until two weeks after the last treatment	Pittsburgh Sleep Quality Index (PSQI); Scale Range: 0-21 points Interpretation: Higher scores indicate poorer sleep quality Assessment: Standardized self-report questionnaire
Heart Rate Variability (HRV)	through study completion, an average of 6 months	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: 10-minute resting-state measurement

Trial Locations

Locations (1)

Polyu; 🇭🇰 Hong Kong, Hong Kong