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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Shoulder function change_1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •patients who practiced yoga, meditation, chi-qong, mindfulness, or deep breathing exercises more than three times per week
Arms & Interventions
Mindfulness-based breathing
20-minute mindfulness-based breathing training
Intervention: Mindfulness-based breathing (Behavioral)
HRV biofeedback
20-minute HRV biofeedback
Intervention: HRV biofeedback (Behavioral)
cognitive-behavioral pain psychoeducation
20-minute psychoeducation session
Intervention: cognitive-behavioral pain psychoeducation (Behavioral)
Outcomes
Primary Outcomes
Shoulder function change_1
Time Frame: Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
American Shoulder and Elbow Surgeons Shoulder Score (ASES). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.
Shoulder function change_2
Time Frame: Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Constant Score to measure the objective ROM. Scores range from 0 to 100 points, representing worst and best shoulder function, respectively.
Visual Analogue Scale change
Time Frame: Baseline, immediately after training, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Subjective post-surgical pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Subjective sleep quality change
Time Frame: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Pittsburgh sleep quality index (PSQI). The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
HRQoL change
Time Frame: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
EQ-5D-5L is a standardized measure of health-related quality of life. The higher transformed scores, the better HRQoL
Emotion-related measurements change
Time Frame: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Hospital Anxiety and Depression Scale (HADS) to measure anxiety and depression in the medical setting. Higher scores indicate greater anxiety and depression.
Secondary Outcomes
- Pain-related fear(Baseline as predictive factor.)
- Pain catastrophizing(Baseline as predictive factor.)
- Objective sleep parameters change(Baseline,and at the 2nd, and 24th week post-operative outpatient follow-up appointments.)
- Neuropsychological change - general cognitive ability(Baseline, and at the 24th week post-operative outpatient follow-up appointments.)
- Neuropsychological change - subjective cognitive ability(Baseline, and at the 24th week post-operative outpatient follow-up appointments.)
- HRV change(Baseline,and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.)
- Neuropsychological change - processing speed(Baseline, and at the 24th week post-operative outpatient follow-up appointments.)
- Neuropsychological change - working memory capacity(Baseline, and at the 24th week post-operative outpatient follow-up appointments.)
- Neuropsychological change - executive control(Baseline, and at the 24th week post-operative outpatient follow-up appointments.)
- Neurophysiological change_1(Baseline, and at the 24th week post-operative outpatient follow-up appointments.)
- Neurophysiological change_2(Baseline, and at the 24th week post-operative outpatient follow-up appointments.)
Investigators
Poyu Chen
Assistant professor
Chang Gung Memorial Hospital