Comparing Mindfulness-based Breath Training and Heart Rate Variability Biofeedback for Shoulder Surgery Patients in the Postoperative Pain.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pain, Postoperative, Shoulder Pain

Intervention / Treatment
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* Behavioral: Mindfulness-based breathing
* Behavioral: HRV biofeedback
* Behavioral: cognitive-behavioral pain psychoeducation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based breathing<br>20-minute mindfulness-based breathing training | Behavioral: Mindfulness-based breathing<br>* The 20-minute mindfulness session is a scripted mindfulness exercise that incorporates mindfulness principles of intentionally paying attention to present-moment experiences in a non-judgmental fashion.<br>|
| Experimental: HRV biofeedback<br>20-minute HRV biofeedback | Behavioral: HRV biofeedback<br>* The 20-minute HRV biofeedback is based on the resonant frequency breathing with an external pacemaker. Generally, the breath rhythm is between 4.5 and 6.5 times per min.<br>|
| Active Comparator: cognitive-behavioral pain psychoeducation<br>20-minute psychoeducation session | Behavioral: cognitive-behavioral pain psychoeducation<br>* The 20-minute psychoeducation session is a supportive session where behavioral coping strategies for pain management are discussed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale change | 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. | Baseline, immediately after training, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments. | 
| Shoulder function change_1 | 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. | Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments. | 
| Shoulder function change_2 | Constant Score to measure the objective ROM. Scores range from 0 to 100 points, representing worst and best shoulder function, respectively. | Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments. | 
| Subjective sleep quality change | 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. | Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments. | 
| Emotion-related measurements change | Hospital Anxiety and Depression Scale (HADS) to measure anxiety and depression in the medical setting. Higher scores indicate greater anxiety and depression. | Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments. | 
| HRQoL change | EQ-5D-5L is a standardized measure of health-related quality of life. The higher transformed scores, the better HRQoL | Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-related fear | Tampa scale of kinesiophobia. The lower TSK total scores means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia. Total scores range from 17 to 68 points. | Baseline as predictive factor. | 
| Pain catastrophizing | Pain catastrophizing Scale (PCS). People are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness. | Baseline as predictive factor. | 
| Neuropsychological change - general cognitive ability | Montreal Cognitive Assessment (MoCA) assesses general cognitive ability. The higher scores, the better the cognitive function. The total possible score is 0 30 points; a score of 26 or above is considered normal. | Baseline, and at the 24th week post-operative outpatient follow-up appointments. | 
| Neuropsychological change - subjective cognitive ability | Everyday Cognition (Ecog-12) assesses subjective cognitive ability. The higher scores, the more subjective cognitive decline. The total possible score is 12 48 points; a score of 14 or above is considered as subjective decline. | Baseline, and at the 24th week post-operative outpatient follow-up appointments. | 
| Neuropsychological change - processing speed | Digit Symbol Coding. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time (e.g. 90 or 120 sec) is measured. | Baseline, and at the 24th week post-operative outpatient follow-up appointments. | 
| Neuropsychological change - working memory capacity | Digit span Wechsler Memory Scale III (WMS-III). The test consists of two parts forward and backward span. The participant is asked to repeat the numbers read in one second intervals in the forward span in the same order. It assesses attention, concentration and short-term memory. In the backward span, the numbers read at one-second intervals are requested to be repeated in reverse order from the end to the beginning. Working memory, which is a component of executive functions, is evaluated. The highest score that can be obtained for the forward span is 8 points, and 7 for the backward span, for a total of 15 points. | Baseline, and at the 24th week post-operative outpatient follow-up appointments. | 
| Neuropsychological change - executive control | Color Trails Test (CCT). The CCT is a cognitive assessment tool by connecting numbered circles and color in sequence. | Baseline, and at the 24th week post-operative outpatient follow-up appointments. | 
| HRV change | HRV refers to the variation in time intervals between consecutive heartbeats by measuring the time duration between R-waves (peak of the QRS complex) on an electrocardiogram (ECG) signal. HRV parameters could be frequency-domain, including low-frequency (LF) and high-frequency (HF) power, and time-domain, including the root mean square of successive differences (RMSSD), and the standard deviation of the IBI of normal sinus beats (SDNN). | Baseline,and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments. | 
| Objective sleep parameters change | Objective sleep parameters will be measured using the wearable device and sleep diary. These sleep parameters include sleep onset latency (SOL), total sleep time (TST), sleep efficiency (SE), and wake after sleep onset (WASO). | Baseline,and at the 2nd, and 24th week post-operative outpatient follow-up appointments. | 
| Neurophysiological change_1 | Change in brain activity at rest. | Baseline, and at the 24th week post-operative outpatient follow-up appointments. | 
| Neurophysiological change_2 | Changes in Amplitude (μv) of EEG signals for event-related potential components. | Baseline, and at the 24th week post-operative outpatient follow-up appointments. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HRV, Shoulder pain, Postoperative pain, mindfulness, biofeedback