Back to resultsComparing Mindfulness-based Breath Training and Heart Rate Variability Biofeedback for Shoulder Surgery Patients in the Postoperative Pain.
Primary Purpose
Pain, Postoperative, Shoulder Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness-based breathing
HRV biofeedback
cognitive-behavioral pain psychoeducation
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative focused on measuring Shoulder pain, Postoperative pain, mindfulness, HRV, biofeedback
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Mindfulness-based breathing
HRV biofeedback
cognitive-behavioral pain psychoeducation
Arm Description
20-minute mindfulness-based breathing training
20-minute HRV biofeedback
20-minute psychoeducation session
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
HRQoL change
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
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
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
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 - 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.
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.
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.
Neuropsychological change - executive control
Color Trails Test (CCT). The CCT is a cognitive assessment tool by connecting numbered circles and color in sequence.
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).
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).
Neurophysiological change_1
Change in brain activity at rest.
Neurophysiological change_2
Changes in Amplitude (μv) of EEG signals for event-related potential components.
Full Information
NCT ID
NCT05917262
First Posted
May 17, 2023
Last Updated
October 17, 2023
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science and Technology Council
1. Study Identification
Unique Protocol Identification Number
NCT05917262
Brief Title
Comparing Mindfulness-based Breath Training and Heart Rate Variability Biofeedback for Shoulder Surgery Patients in the Postoperative Pain.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science and Technology Council
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Shoulder Pain
Keywords
Shoulder pain, Postoperative pain, mindfulness, HRV, biofeedback
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-based breathing
Arm Type
Experimental
Arm Description
20-minute mindfulness-based breathing training
Arm Title
HRV biofeedback
Arm Type
Experimental
Arm Description
20-minute HRV biofeedback
Arm Title
cognitive-behavioral pain psychoeducation
Arm Type
Active Comparator
Arm Description
20-minute psychoeducation session
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based breathing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HRV biofeedback
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
cognitive-behavioral pain psychoeducation
Intervention Description
The 20-minute psychoeducation session is a supportive session where behavioral coping strategies for pain management are discussed.
Primary Outcome Measure Information:
Title
Visual Analogue Scale change
Description
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.
Title
Shoulder function change_1
Description
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.
Title
Shoulder function change_2
Description
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.
Title
Subjective sleep quality change
Description
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.
Title
Emotion-related measurements change
Description
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.
Title
HRQoL change
Description
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.
Secondary Outcome Measure Information:
Title
Pain-related fear
Description
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.
Title
Pain catastrophizing
Description
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.
Title
Neuropsychological change - general cognitive ability
Description
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.
Title
Neuropsychological change - subjective cognitive ability
Description
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.
Title
Neuropsychological change - processing speed
Description
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.
Title
Neuropsychological change - working memory capacity
Description
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.
Time Frame
Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Title
Neuropsychological change - executive control
Description
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.
Title
HRV change
Description
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.
Title
Objective sleep parameters change
Description
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.
Title
Neurophysiological change_1
Description
Change in brain activity at rest.
Time Frame
Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Title
Neurophysiological change_2
Description
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.
Other Pre-specified Outcome Measures:
Title
Cytokine
Description
Joint fluid or plasma will be obtained via aspiration from the shoulder joint of each patient at the beginning of the surgery.
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Poyu Chen, PhD
Phone
+886-3211-8800
Ext
5449
Email
poyuchen@gap.cgu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Hao Chiu, M.D.
Organizational Affiliation
Chang Gung MH
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparing Mindfulness-based Breath Training and Heart Rate Variability Biofeedback for Shoulder Surgery Patients in the Postoperative Pain.
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