Clinical trial NCT05917262: 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
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Shoulder Pain
Keywords: Shoulder pain
Postoperative pain
mindfulness
HRV
biofeedback
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
First posted: 2023-06-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Visual Analogue Scale change
timeFrame: Baseline, immediately after training, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
measure: Shoulder function change_1
timeFrame: Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
measure: Shoulder function change_2
timeFrame: Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
measure: Subjective sleep quality change
timeFrame: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
measure: Emotion-related measurements change
timeFrame: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
measure: HRQoL change
timeFrame: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Secondary outcomes:
measure: Pain-related fear
timeFrame: Baseline as predictive factor.
measure: Pain catastrophizing
timeFrame: Baseline as predictive factor.
measure: Neuropsychological change - general cognitive ability
timeFrame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
measure: Neuropsychological change - subjective cognitive ability
timeFrame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
measure: Neuropsychological change - processing speed
timeFrame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
measure: Neuropsychological change - working memory capacity
timeFrame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
measure: Neuropsychological change - executive control
timeFrame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
measure: HRV change
timeFrame: Baseline,and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
measure: Objective sleep parameters change
timeFrame: Baseline,and at the 2nd, and 24th week post-operative outpatient follow-up appointments.
measure: Neurophysiological change_1
timeFrame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
measure: Neurophysiological change_2
timeFrame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Other outcomes:
measure: Cytokine
timeFrame: During surgery
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung MH
name: Chih-Hao Chiu, M.D.
role: STUDY_CHAIR
References: