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

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

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 Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Shoulder Pain
• Intervention / Treatment: Behavioral: Mindfulness-based breathing; Behavioral: HRV biofeedback; Behavioral: cognitive-behavioral pain psychoeducation

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Poyu Chen, PhD; Phone Number: 5449 +886-3211-8800; Email: poyuchen@gap.cgu.edu.tw

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: ChihHao Chiu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 - 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.
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.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytokine	Joint fluid or plasma will be obtained via aspiration from the shoulder joint of each patient at the beginning of the surgery.	During surgery

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: National Science and Technology Council
• Investigators: Study Chair: Chih-Hao Chiu, M.D., Chang Gung MH

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: biofeedback; mindfulness; HRV; Postoperative pain; Shoulder pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain, Postoperative; Shoulder Pain
• Other Study ID Numbers: 202202303B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No