Pain (Knee)NCT07896954
A Comparison of Heart Rate Variability Biofeedback, Mindfulness, and Psychoeducation-based Interventions on Clinical Recovery Outcomes in Patients Undergoing Total Knee Arthroplasty
A study testing Heart rate variability biofeedback, Mindfulness and psychoeducation in people with Pain (Knee) and Pain and Anxiety, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial summary
The goal of this clinical trial is to compare the effects of heart rate variability biofeedback (HRVB), mindfulness meditation, and psychological education in patients undergoing total knee arthroplasty (TKA). Patients waiting for TKA often experience anxiety, pain, and sleep problems before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain (Knee), Pain and Anxiety, TKA
- What is being tested?
- Heart rate variability biofeedback, Mindfulness and psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTaiwan
- Study dates
- 21 Jan 2026to 31 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing total knee arthroplasty (TKA) with
- pain ≥3 months and ≥3 days per week
- pain intensity ≥40 (VAS scale from 0 no pain to 100 very painful)
- willingness to participate in this trial before surgery, follow postoperative home-based breathing training, and not receive other related interventions
- surgical indication based on orthopedic physician's opinion
Who cannot join
- history of surgery on the same knee
- osteoporotic fractures or rheumatologic diseases
- chronic widespread pain
- neurological disease (i.e., stroke, Parkinson's disease, etc.)
- psychiatric disease (i.e., dementia, depression, schizophrenia, etc.)
- cancer
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333
Poyu Chen, PhD, +886-3-211-8800 ext. 5449, poyuchen@mail.cgu.edu.tw
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
ChihHao Chiu, PhD, MD
About this study
The goal of this clinical trial is to compare the effects of heart rate variability biofeedback (HRVB), mindfulness meditation, and psychological education in patients undergoing total knee arthroplasty (TKA). Patients waiting for TKA often experience anxiety, pain, and sleep problems before surgery. These factors may affect recovery after surgery. HRVB and mindfulness have been used to reduce stress and anxiety in different patient groups, but few studies have directly compared these approaches in patients undergoing TKA.
The main questions this study aims to answer are:
Read more
- Does HRVB improve postoperative recovery, including pain, sleep quality, quality of life, and knee function, compared with mindfulness meditation and psychological education?
- Do HRVB and mindfulness meditation reduce preoperative anxiety more effectively than psychological education?
- Are changes in heart rate variability and EEG measures related to recovery outcomes after surgery?
Researchers will compare HRVB, mindfulness meditation, and psychological education to evaluate their effects on anxiety reduction and postoperative recovery.
Participants will:
- Be randomly assigned to one of three groups: HRVB, mindfulness meditation, or psychological education.
- Receive one 15-minute intervention session before surgery.
- Continue home-based practice during the first 2 weeks after surgery while following routine rehabilitation exercises.
- Complete assessments before surgery and at 2, 6, and 12 weeks after surgery.
The assessments will include measures of anxiety, pain, sleep quality, quality of life, knee function, heart rate variability, and EEG activity.
- Conditions
- Pain (Knee), Pain and Anxiety, TKA
- Being tested
- Heart rate variability biofeedback, Mindfulness, psychoeducation
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate variability biofeedbackBehavioural
The 15-minute preoperative HRV biofeedback session consists of five 3-minute stages of resonance-frequency breathing (generally 4.5 to 6.5 breaths per minute) guided by an external pacer. During postoperative weeks 0-2, participants practice HRV biofeedback daily at home using a remote wearable HRV biofeedback device.
MindfulnessBehavioural
The 15-minute preoperative mindfulness session is a scripted exercise recorded by a professional mindfulness instructor. It guides participants to attend to the breath and bodily sensations and to accept wandering thoughts, negative emotions and pain in a non-judgmental fashion. During postoperative weeks 0-2, participants continue practice at home using the recording.
psychoeducationBehavioural
The 15-minute preoperative psychoeducation session provides pain education and discusses behavioral coping strategies for pain management. During postoperative weeks 0-2, participants review the course content at home as needed.
| Study group | Role | What they receive |
|---|---|---|
| HRV biofeedback | Experimental | A single 15-minute preoperative HRV biofeedback session (five 3-minute stages of resonance-frequency breathing), followed by daily home-based HRV biofeedback practice with a wearable device during postoperative weeks 0-2, in addition to routine home rehabilitation exercises. Receives: Behavioral: Heart rate variability biofeedback |
| Mindfulness-based breathing | Active comparator | A single 15-minute preoperative mindfulness-based breathing session, followed by home practice with a recorded mindfulness guide during postoperative weeks 0-2, in addition to routine home rehabilitation exercises. Receives: Behavioral: Mindfulness |
| Cognitive-Behavioral Pain Psycho-Education | Active comparator | A single 15-minute preoperative pain psychoeducation session, followed by reviewing the course content at home as needed during postoperative weeks 0-2, in addition to routine home rehabilitation exercises. Receives: Behavioral: psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale change
Subjective post-surgical pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Pittsburgh Sleep Quality Index (PSQI)
The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Hospital Anxiety and Depression Scale (HADS)
HADS measures anxiety and depression in the medical setting. Higher scores indicate greater anxiety and depression.
Measured: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
EuroQol-5D questionnaire (EQ-5D)
EQ-5D-5L is a standardized measure of health-related quality of life. The higher transformed scores, the better HRQoL.
Measured: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Secondary outcomes (11)
Visual Analogue Scale for Anxiety (VAS-A)
Subjective anxiety rated on a 100-mm line from 0 (no anxiety) to 100 (worst imaginable anxiety). Higher scores indicate greater anxiety.
Measured: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Heart rate variability (HRV)
Time-domain (SDNN, RMSSD) and frequency-domain (LF, HF power) HRV indices derived from short-term ECG/PPG recordings. Higher RMSSD and HF indicate greater parasympathetic activity.
Measured: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Knee injury and Osteoarthritis Outcome Score (KOOS)
Patient-reported knee function across five subscales (pain, symptoms, activities of daily living, sport/recreation, knee-related quality of life), each scored 0-100. Higher scores indicate better function.
Measured: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Knee range of motion (ROM)
Active knee flexion and extension measured in degrees with a goniometer. Larger flexion range indicates better knee mobility.
Measured: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Manual muscle testing (MMT) of hamstrings and quadriceps
Hamstring and quadriceps strength graded on the 0-5 manual muscle testing scale. Higher grades indicate greater muscle strength.
Measured: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Timed Up and Go Test (TUG)
Time (seconds) to rise from a chair, walk 3 meters, turn, walk back and sit down. Shorter times indicate better functional mobility.
Measured: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
2-Minute Walk Test (2MWT)
Distance (meters) walked in 2 minutes. Longer distances indicate better walking capacity.
Measured: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Tampa Scale for Kinesiophobia (TSK-11)
11-item questionnaire assessing fear of movement and re-injury, total score 11-44. Higher scores indicate greater kinesiophobia. Assessed as a predictor of postoperative recovery.
Measured: Baseline (preoperative)
Pain Catastrophizing Scale (PCS)
13-item questionnaire assessing rumination, magnification and helplessness about pain, total score 0-52. Higher scores indicate greater pain catastrophizing. Assessed as a predictor of postoperative recovery.
Measured: Baseline (preoperative)
State-Trait Anxiety Inventory (STAI-S/T)
Two 20-item subscales measuring state and trait anxiety, each scored 20-80. Higher scores indicate greater anxiety.
Measured: Baseline (preoperative) and 12 weeks after surgery
Beck Depression Inventory (BDI)
21-item self-report measure of depressive symptoms, total score 0-63. Higher scores indicate more severe depressive symptoms.
Measured: Baseline (preoperative) and 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start21 Jan 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain (Knee)Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Poyu Chen, Chang Gung Memorial Hospital
- Investigators
- Chih-Hao Chiu, PhD, MD, Study chair, Chang Gung MHPoyu Chen, PhD, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896954
- Sponsor's protocol ID
- 202501041B0
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because participants did not consent to data sharing beyond the research team, as approved by the Institutional Review Board of Chang Gung Medical Foundation. De-identified data may be made available from the principal investigator upon reasonable request and with IRB approval.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Heart Rate Variability Biofeedback, Mindfulness, and Psychoeducation-based Interventions on Clinical Recovery Outcomes in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07896954
- Acronym / sponsor ID
- 202501041B0
- Conditions
- Pain (Knee), Pain and Anxiety, TKA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the effects of heart rate variability biofeedback (HRVB), mindfulness meditation, and psychological education in patients undergoing total knee arthroplasty (TKA). Patients waiting for TKA often experience anxiety, pain, and sleep problems before surgery. These factors may affect recovery after surgery. HRVB and mindfulness have been used to reduce stress and anxiety in different patient groups, but few studies have directly compared these approaches in patients undergoing TKA.
The main questions this study aims to answer are:
- Does HRVB improve postoperative recovery, including pain, sleep quality, quality of life, and knee function, compared with mindfulness meditation and psychological education?
- Do HRVB and mindfulness meditation reduce preoperative anxiety more effectively than psychological education?
- Are changes in heart rate variability and EEG measures related to recovery outcomes after surgery?
Researchers will compare HRVB, mindfulness meditation, and psychological education to evaluate their effects on anxiety reduction and postoperative recovery.
Participants will:
- Be randomly assigned to one of three groups: HRVB, mindfulness meditation, or psychological education.
- Receive one 15-minute intervention session before surgery.
- Continue home-based practice during the first 2 weeks after surgery while following routine rehabilitation exercises.
- Complete assessments before surgery and at 2, 6, and 12 weeks after surgery.
The assessments will include measures of anxiety, pain, sleep quality, quality of life, knee function, heart rate variability, and EEG activity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HRV biofeedback | Experimental | Behavioral: Heart rate variability biofeedbackA single 15-minute preoperative HRV biofeedback session (five 3-minute stages of resonance-frequency breathing), followed by daily home-based HRV biofeedback practice with a wearable device during postoperative weeks 0-2, in addition to routine home rehabilitation exercises. |
| Mindfulness-based breathing | Active comparator | Behavioral: MindfulnessA single 15-minute preoperative mindfulness-based breathing session, followed by home practice with a recorded mindfulness guide during postoperative weeks 0-2, in addition to routine home rehabilitation exercises. |
| Cognitive-Behavioral Pain Psycho-Education | Active comparator | Behavioral: psychoeducationA single 15-minute preoperative pain psychoeducation session, followed by reviewing the course content at home as needed during postoperative weeks 0-2, in addition to routine home rehabilitation exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients undergoing total knee arthroplasty (TKA) with
- pain ≥3 months and ≥3 days per week
- pain intensity ≥40 (VAS scale from 0 no pain to 100 very painful)
- willingness to participate in this trial before surgery, follow postoperative home-based breathing training, and not receive other related interventions
- surgical indication based on orthopedic physician's opinion
Key exclusion criteria (6 listed)
- history of surgery on the same knee
- osteoporotic fractures or rheumatologic diseases
- chronic widespread pain
- neurological disease (i.e., stroke, Parkinson's disease, etc.)
- psychiatric disease (i.e., dementia, depression, schizophrenia, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate variability biofeedbackThe 15-minute preoperative HRV biofeedback session consists of five 3-minute stages of resonance-frequency breathing (generally 4.5 to 6.5 breaths per minute) guided by an external pacer. During postoperative weeks 0-2, participants practice HRV biofeedback daily at home using a remote wearable HRV biofeedback device. | Behavioural | HRV biofeedback |
| MindfulnessThe 15-minute preoperative mindfulness session is a scripted exercise recorded by a professional mindfulness instructor. It guides participants to attend to the breath and bodily sensations and to accept wandering thoughts, negative emotions and pain in a non-judgmental fashion. During postoperative weeks 0-2, participants continue practice at home using the recording. | Behavioural | Mindfulness-based breathing |
| psychoeducationThe 15-minute preoperative psychoeducation session provides pain education and discusses behavioral coping strategies for pain management. During postoperative weeks 0-2, participants review the course content at home as needed. | Behavioural | Cognitive-Behavioral Pain Psycho-Education |
Primary outcome
Visual Analogue Scale change
Time frame: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Subjective post-surgical pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
HADS measures anxiety and depression in the medical setting. Higher scores indicate greater anxiety and depression.
EuroQol-5D questionnaire (EQ-5D)
Time frame: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
EQ-5D-5L is a standardized measure of health-related quality of life. The higher transformed scores, the better HRQoL.
11 secondary outcomes
Visual Analogue Scale for Anxiety (VAS-A)
Time frame: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Heart rate variability (HRV)
Time frame: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Knee range of motion (ROM)
Time frame: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Manual muscle testing (MMT) of hamstrings and quadriceps
Time frame: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Timed Up and Go Test (TUG)
Time frame: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
2-Minute Walk Test (2MWT)
Time frame: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
Tampa Scale for Kinesiophobia (TSK-11)
Time frame: Baseline (preoperative)
Pain Catastrophizing Scale (PCS)
Time frame: Baseline (preoperative)
State-Trait Anxiety Inventory (STAI-S/T)
Time frame: Baseline (preoperative) and 12 weeks after surgery
Beck Depression Inventory (BDI)
Time frame: Baseline (preoperative) and 12 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because participants did not consent to data sharing beyond the research team, as approved by the Institutional Review Board of Chang Gung Medical Foundation. De-identified data may be made available from the principal investigator upon reasonable request and with IRB approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chih-Hao Chiu, PhD, MD study chair
Chang Gung MH
Poyu Chen, PhD principal investigator
Chang Gung University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate variability biofeedback, Mindfulness and psychoeducation in people with Pain (Knee) and Pain and Anxiety, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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. 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?
Contact Poyu Chen, PhD (+886-3-211-8800 ext. 5449, poyuchen@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale change (time frame: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery). The study lists 4 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 27 Oct 2026.