An interventional study of Heart rate variability biofeedback and Mindfulness in Pain (Knee), Pain and Anxiety and TKA, sponsored by Chang Gung Memorial Hospital. Recruiting at 2 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Supportive care
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:
Researchers will compare HRVB, mindfulness meditation, and psychological education to evaluate their effects on anxiety reduction and postoperative recovery.
Participants will:
The assessments will include measures of anxiety, pain, sleep quality, quality of life, knee function, heart rate variability, and EEG activity.
2,461 studies on the registry are indexed under Pain; 942 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 2,102 interventional studies indexed under Pain.
Browse Pain studies →Chang Gung Memorial Hospital is the lead sponsor of 1,094 studies on the registry; 239 are open to participants now.
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patients undergoing total knee arthroplasty (TKA) with
Exclusion Criteria:
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.
Behavioral: Heart rate variability biofeedback
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.
Behavioral: Mindfulness
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.
Behavioral: psychoeducation
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (preoperative) and at 2, 6, and 12 weeks after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (preoperative) and 12 weeks after surgery
Plan to share: 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.
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Jul 2027, 18 months after the start.
Of 1,253 non-industry interventional studies with no phase under Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's planned 18 months is above that.
Counting every sponsor, half of 1,276 studies reached it within 11 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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