Actively Recruiting
Comparing Preoperative Mindfulness-based Breath Training and Heart Rate Variability Biofeedback for Shoulder Surgery Patients in Postoperative Pain, Shoulder Function, Emotion, Sleep, Quality of Life, Cognitive Function, and Electroencephalography
Led by Chang Gung Memorial Hospital · Updated on 2026-05-22
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Chang Gung Memorial Hospital
Lead Sponsor
N
National Science and Technology Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of three different types of bio-psychosocial support for patients preparing for shoulder surgery who experience ongoing pain after surgery. The study compares brief mindfulness-based breathing, heart rate variability biofeedback (HRV-BF), and cognitive-behavioral pain psychoeducation to understand which method may better help with postoperative pain, shoulder function, emotion, sleep quality, quality of life, cognitive function, and brain activity. This is a randomized, single-blind study led by Chang Gung Memorial Hospital. Participants will be assigned randomly to one of three groups: a 20-minute mindfulness-based breathing training session, a 20-minute HRV biofeedback session using paced breathing, or a 20-minute cognitive-behavioral pain psychoeducation session focused on coping strategies. Each intervention is delivered once before surgery. The study will follow patients for 24 weeks after surgery to assess the effects of these treatments on various outcomes. During the study, participants will have several outpatient follow-up appointments at baseline, immediately after training, and at 2, 6, 12, and 24 weeks after surgery. At these visits, researchers will measure pain levels using the Visual Analogue Scale, shoulder function, sleep quality, emotional state, quality of life, cognitive abilities, heart rate variability, objective sleep parameters, and brain activity through electroencephalography. Additional assessments at baseline will include pain-related fear and catastrophizing. This comprehensive monitoring aims to capture the treatments' impact over time.
CONDITIONS
Brief Title
Comparing Mindfulness-based Breath Training and Heart Rate Variability Biofeedback for Shoulder Surgery Patients in the Postoperative Pain.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Shoulder pain lasting at least 3 months and occurring at least 3 days per week
- Pain intensity of 40 or higher on a Visual Analogue Scale from 0 to 100
- Surgical indication confirmed by an orthopedic specialist
You will not qualify if you...
- History of shoulder surgery in the past 3 years
- Osteoporotic vertebral fractures or rheumatologic diseases
- Chronic widespread pain syndromes such as fibromyalgia or chronic fatigue syndrome
- Neurological diseases including stroke and Parkinson's disease
- Psychiatric diseases including dementia, depression, and schizophrenia
- Cancer
- Regular practice of yoga, meditation, chi-qong, mindfulness, or deep breathing exercises more than three times per week
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session before surgery
Participants receive a 20-minute session of either mindfulness-based breathing training, heart rate variability biofeedback, or cognitive-behavioral pain psychoeducation before surgery.
1 visit (in-person)
Duration - Until hospital discharge
Participants undergo shoulder surgery followed by immediate post-operative care.
Inpatient care visits as per routine surgical care
Duration - 24 weeks
Participants attend outpatient follow-up visits for assessments of pain, shoulder function, sleep quality, emotion, quality of life, cognitive function, and neurophysiological changes.
Visits at 2nd, 6th, 12th, and 24th week post-operative outpatient follow-ups
Trial Site Locations
Total: 1 location
1
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Actively Recruiting
Research Team
P
Poyu Chen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here