Effects of Tuijing Therapy on Heart Rate Variability and Psychological Symptoms (TJ)

Effects of Tuijing Therapy on Heart Rate Variability and Psychological Symptoms: a Randomized Controlled Pilot Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Depression
• Intervention / Treatment: Behavioral: Tui Jing therapy; Device: sham ultrasound intervention

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • PolyU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Tui Jing Group; 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.	Behavioral: Tui Jing therapy; Tui Jing therapy (Gua Sha + Meridian pressure) was utilized, a specialized form of Gua Sha that incorporates traditional techniques with targeted pressure on specific meridians.
Sham Comparator: The Sham control; 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 they can't distinguish between the active and the sham interventions.	Device: sham ultrasound intervention; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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, monthly during intervention, post-intervention	through study completion, an average of 6 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 6 months
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 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 date of randomization until two weeks after the last treatment
Subjective Sleep Quality	Measurement: 10-point Likert scale (1 = "Very Poor", 10 = "Excellent") Unit: Scale score (1-10) Tool: Standardized sleep diary	From 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: 10-minute resting-state measurement	through study completion, an average of 6 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) Quality Control: Imaging environment: Standardized D65 lighting Analysis software: IBOOLO SkinAnalyzer Pro v3.2	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2025
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: December 29, 2024
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: depression; HRV; Tui Jing
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2024-TJ; ZH3P (Other Grant/Funding Number: the Bright Future Charitable Fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Confidentiality Agreement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes