Comparing mindfulness breathing and biofeedback for pain relief after shoulder surgery
Comparing Preoperative Mindfulness-based Breath Training and Heart Rate Variability Biofeedback for Shoulder Surgery Patients in the Postoperative Pain, Shoulder Function, Emotion, Sleep, Quality of Life, Cognitive Function, and Electroencephalography
This study tests whether mindfulness breathing, biofeedback, or pain education can help people who are having shoulder surgery feel less pain and recover better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT05917262 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of three different bio-psychosocial support interventions for patients undergoing shoulder surgery. Participants will be randomized to receive either mindfulness-based breathing, heart rate variability biofeedback, or cognitive behavioral pain psychoeducation. The goal is to assess how these interventions impact postoperative pain levels and overall recovery. The study focuses on patients who have experienced shoulder pain for at least three months and are scheduled for surgery.
Who should consider this trial
Good fit: Ideal candidates are patients with shoulder pain lasting at least three months and experiencing significant pain intensity who are scheduled for surgery.
Not a fit: Patients with a history of shoulder surgery in the past three years or those with certain chronic conditions or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-pharmacological strategies to manage postoperative pain in shoulder surgery patients.
How similar studies have performed: Previous studies have shown promise in using mindfulness and biofeedback techniques for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taoyuan
- Chang Gung Memorial Hospital — Taoyuan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Poyu Chen, PhD
- Email: poyuchen@gap.cgu.edu.tw
- Phone: +886-3211-8800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.