Heart rate variability biofeedback, mindfulness, or psychoeducation after knee replacement
Official title: A Comparison of Heart Rate Variability Biofeedback, Mindfulness, and Psychoeducation-based Interventions on Clinical Recovery Outcomes in Patients Undergoing Total Knee Arthroplasty
Run by Chang Gung Memorial Hospital · NCT07896954 · Data updated 2026-11-12
This trial tests whether heart rate variability biofeedback, mindfulness, or psychoeducation help people recover better after total knee arthroplasty.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 2 sites (Taoyuan and 1 other locations) |
| Status | Recruiting |
| Started | January 21, 2026 |
| Main results expected | July 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07896954 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults awaiting total knee arthroplasty with chronic knee pain, adequate pain levels, and willingness to participate preoperatively and engage in home-based breathing training after surgery.
✕Probably not a fit
Patients with prior knee surgery, certain chronic diseases, or psychiatric or neurological conditions may not benefit from these interventions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares three approaches—heart rate variability biofeedback, mindfulness meditation, and psychological education—to see which improves recovery after total knee arthroplasty. Participants are adults with chronic knee pain preparing for surgery, and they will use the assigned intervention preoperatively and perform home-based breathing training postoperatively. Outcomes include pain, sleep quality, quality of life, and knee function, along with anxiety and physiological measures such as heart rate variability and EEG. The goal is to determine which method best supports postoperative recovery and whether physiological changes relate to outcomes. The study is conducted at Chang Gung Memorial Hospital in Taiwan.
Why it matters
Potential benefit: If successful, patients may experience less preoperative anxiety and better postoperative recovery and knee function.
How similar studies have gone: Previous work suggests HRV biofeedback and mindfulness can reduce stress in various patient groups, but direct comparisons in TKA are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: patients undergoing total knee arthroplasty (TKA) with 1. pain ≥3 months and ≥3 days per week 2. pain intensity ≥40 (VAS scale from 0 no pain to 100 very painful) 3. willingness to participate in this trial before surgery, follow postoperative home-based breathing training, and not receive other related interventions 4. surgical indication based on orthopedic physician's opinion Exclusion Criteria: 1. history of surgery on the same knee 2. osteoporotic fractures or rheumatologic diseases 3. chronic widespread pain 4. neurological disease (i.e., stroke, Parkinson's disease, etc.) 5. psychiatric disease (i.e., dementia, depression, schizophrenia, etc.) 6. cancer
Where it's running
-
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan Recruiting -
Chang Gung Memorial Hospital
Taoyuan, Taiwan Recruiting
Study contacts
- Principal investigator: Poyu Chen, PhD — Chang Gung University
- Study coordinator: Poyu Chen, PhD
- Email: poyuchen@mail.cgu.edu.tw
- Phone: +886-3-211-8800
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.