Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment120 (estimated)
SponsorChang Gung Memorial Hospital
Academic / other
Locations2 sites (Taoyuan and 1 other locations)
StatusRecruiting
StartedJanuary 21, 2026
Main results expectedJuly 31, 2027
Study endsDecember 31, 2027
Registry record updatedOctober 27, 2026
Trial IDNCT07896954 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.