Comparing Mindfulness-based Breath Training and Heart Rate Variability Biofeedback for Shoulder Surgery Patients in the Postoperative Pain.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mindfulness-based breathing 20-minute mindfulness-based breathing training |
Behavioral: Mindfulness-based breathing
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.
|
| Experimental: HRV biofeedback 20-minute HRV biofeedback |
Behavioral: HRV biofeedback
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.
|
| Active Comparator: cognitive-behavioral pain psychoeducation 20-minute psychoeducation session |
Behavioral: cognitive-behavioral pain psychoeducation
The 20-minute psychoeducation session is a supportive session where behavioral coping strategies for pain management are discussed.
|
Outcome Measures
Primary Outcome Measures
- Visual Analogue Scale change [Baseline, immediately after training, and at the 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.
- Shoulder function change_1 [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 [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.
- Subjective sleep quality change [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.
- Emotion-related measurements change [Baseline, and at the 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.
- HRQoL change [Baseline, and at the 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
Secondary Outcome Measures
- Pain-related fear [Baseline as predictive factor.]
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.
- Pain catastrophizing [Baseline as predictive factor.]
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.
- Neuropsychological change - general cognitive ability_1 [Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
Mini-Mental State Examination assesses general cognitive ability. The higher scores, the better the cognitive function. The value is 0~30 points; a score of 26 or above is considered normal.
- Neuropsychological change - general cognitive ability_2 [Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
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.
- Neuropsychological change - processing speed [Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
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.
- Neuropsychological change - working memory capacity [Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
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.
- Neuropsychological change - executive control [Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
Color Trails Test (CCT). The CCT is a cognitive assessment tool by connecting numbered circles and color in sequence.
- HRV change [Baseline,and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.]
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).
- Neurophysiological change_1 [Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
Change in brain activity at rest.
- Neurophysiological change_2 [Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
Changes in Amplitude (μv) of EEG signals for event-related potential components.
Other Outcome Measures
- Cytokine [During surgery]
Joint fluid or plasma will be obtained via aspiration from the shoulder joint of each patient at the beginning of the surgery.
Eligibility Criteria
Criteria
Inclusion Criteria:
shoulder pain patients with
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(1) pain ≥3months and ≥3 days per week
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(2) pain intensity ≥ 40 (VAS scale from 0 no pain to 100 very painful)
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(3) the surgical indication would be based on orthopedics opinions
Exclusion Criteria:
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history of shoulder surgery in the prior 3 years
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osteoporotic vertebral fractures or rheumatologic diseases
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chronic widespread pain syndromes (fibromyalgia or chronic fatigue syndrome)
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neurological disease (i.e., stroke, parkinson's disease, etc..)
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psychiatric disease (i.e., dementia, depression, schizophrenia, etc)
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cancer
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patients who practiced yoga, meditation, chi-qong, mindfulness, or deep breathing exercises more than three times per week
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Chang Gung Memorial Hospital
- National Science and Technology Council
Investigators
- Study Chair: Chih-Hao Chiu, M.D., Chang Gung MH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202202303B0