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DepressionTJNCT06888284

Effects of Tuijing Therapy on Heart Rate Variability and Psychological Symptoms

A study testing Tui Jing therapy in people with Depression, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Depression
What is being tested?
Tui Jing therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteHong Kong
Study dates
10 Mar 2025to 31 Aug 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hong Kong1 site
  • Polyu

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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.

Read more

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.

Read the 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.

Conditions
Depression
Being tested
Tui Jing therapy, sham ultrasound intervention
Keywords
depression, HRV, Tui Jing
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tui Jing therapyBehavioural

    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 ultrasound interventionDevice

    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

Study groups in NCT06888284
Study groupRoleWhat they receive
The Tui Jing GroupExperimentalTui 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.
Receives: Behavioral: Tui Jing therapy
The Sham controlSham comparatorParticipants 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.
Receives: Device: sham ultrasound intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: through study completion, an average of 6 months

  2. Intervention Liking Rate

    Intervention Liking Rate

    Measurement: Binary response (Yes/No) Unit: Percentage (% "Yes" responses) Tool: Structured interview

    Measured: through study completion, an average of 6 months

  3. Recommendation Willingness Rate

    Recommendation Willingness Rate

    Measurement: Binary response (Yes/No) Unit: Percentage (% "Yes" responses) Tool: Structured interview

    Measured: through study completion, an average of 6 months

  4. Eligibility Rate

    Eligibility Rate

    Formula: (Number of eligible individuals / Total screened) × 100% Unit: Percentage (%) Data Source: Screening records

    Measured: through study completion, an average of 6 months

  5. Recruitment Rate

    Recruitment Rate

    Formula: (Number of consented participants / Eligible individuals) × 100% Unit: Percentage (%) Data Source: Recruitment database

    Measured: through study completion, an average of 6 months

  6. Retention Rate

    Retention Rate

    Formula: (Number of completers / Enrolled participants) × 100% Unit: Percentage (%) Data Source: Follow-up records

    Measured: through study completion, an average of 6 months

  7. Adverse Event Rate

    Adverse Event Rate

    Formula: (Participants reporting adverse events / Total participants) × 100% Unit: Percentage (%) Data Source: Adverse event report forms

    Measured: through study completion, an average of 6 months

  8. Attrition Rate

    Attrition Rate

    Formula: (Number of withdrawals / Enrolled participants) × 100% Unit: Percentage (%) Data Source: Withdrawal documentation

    Measured: through study completion, an average of 6 months

  9. Adherence Rate

    Adherence Rate

    Formula: (Days of full protocol adherence / Total intervention days) × 100% Unit: Percentage (%) Data Source: Intervention logs

    Measured: through study completion, an average of 6 months

Secondary outcomes (7)
  1. 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

    Measured: through study completion, an average of 6 months

  2. 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

    Measured: through study completion, an average of 6 months

  3. Sleep quality

    Pittsburgh Sleep Quality Index (PSQI)

    Scale Range: 0-21 points Interpretation: Higher scores indicate poorer sleep quality Assessment: Standardized self-report questionnaire

    Measured: From date of randomization until two weeks after the last treatment

  4. 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

    Measured: From date of randomization until two weeks after the last treatment

  5. Subjective Sleep Quality

    Measurement: 10-point Likert scale (1 = "Very Poor", 10 = "Excellent") Unit: Scale score (1-10) Tool: Standardized sleep diary

    Measured: From date of randomization until two weeks after the last treatment

  6. 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

    Measured: through study completion, an average of 6 months

  7. 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

    Measured: through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2025
  2. Study start10 Mar 2025 (estimated)
  3. Primary completion31 Jul 2025 (estimated)
  4. Study completion31 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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 person not involved in the recruitment of 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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06888284
Sponsor's protocol ID
2024-TJ
Other IDs
ZH3P
Acronym
TJ
Status last verified
Mar 2025
First submitted
29 Dec 2024
Last updated
21 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: Confidentiality Agreement

Questions about this trial

What is this clinical trial studying?

A study testing Tui Jing therapy in people with Depression, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Satisfaction (time frame: through study completion, an average of 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.

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