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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
120
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.
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.
The 20-minute psychoeducation session is a supportive session where behavioral coping strategies for pain management are discussed.
Chang Gung Memorial Hospital
Taoyuan, Taiwan
RECRUITINGVisual 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline,and at the 2nd, and 24th week post-operative outpatient follow-up appointments.
Neurophysiological change_1
Change in brain activity at rest.
Time frame: 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.
Time frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.