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A Comparison of Heart Rate Variability Biofeedback, Mindfulness, and Psychoeducation-based Interventions on Clinical Recovery Outcomes in Patients Undergoing Total Knee Arthroplasty

RecruitingNAAges 18 Years - anyAllChang Gung Memorial Hospital
NCT07896954 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 va

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📋 Eligibility rules (as published)
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
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What it tests

  • Heart rate variability biofeedback
  • Mindfulness
  • psychoeducation
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Where

2 sites
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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