NCT05917262 Comparing Mindfulness-based Breath Training and Heart Rate Variability Biofeedback for Shoulder Surgery Patients in the Postoperative Pain.
| NCT ID | NCT05917262 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Pain, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-11-13 |
| Primary Completion | 2026-07-31 |
Trial Parameters
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Brief Summary
Although shoulder surgeries can effectively relieve pain intensity and restore shoulder function, some patients reported persistent post-operative pain at the 6-month post-surgery follow-up visit. This randomized study aims to determine the effectiveness of three different types of bio-psychosocial support to pre-operative shoulder surgery patients. This study will examine the differential effects of brief mindfulness-based breathing, heart rate variability biofeedback (HRV-BF), and cognitive behavioral pain psychoeducation for pre-operative patients.
Eligibility Criteria
Inclusion Criteria: shoulder pain patients with * (1) pain ≥3months and ≥3 days per week * (2) pain intensity ≥ 40 (VAS scale from 0 no pain to 100 very painful) * (3) the surgical indication would be based on orthopedics opinions Exclusion Criteria: * history of shoulder surgery in the prior 3 years * osteoporotic vertebral fractures or rheumatologic diseases * chronic widespread pain syndromes (fibromyalgia or chronic fatigue syndrome) * neurological disease (i.e., stroke, parkinson's disease, etc..) * psychiatric disease (i.e., dementia, depression, schizophrenia, etc) * cancer * patients who practiced yoga, meditation, chi-qong, mindfulness, or deep breathing exercises more than three times per week