Comparing Mindfulness-based Breath Training and Heart Rate Variability Biofeedback for Shoulder Surgery Patients in the Postoperative Pain.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness-based breathing, HRV biofeedback, cognitive-behavioral pain psychoeducation.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative, Shoulder Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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. - 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. - Behavioral cognitive-behavioral pain psychoeducation
The 20-minute psychoeducation session is a supportive session where behavioral coping strategies for pain management are discussed.
Primary outcome measures
- Visual Analogue Scale change [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 [Time frame: Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.]
- Shoulder function change_2 [Time frame: Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.]
- Subjective sleep quality change [Time frame: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.]
- Emotion-related measurements change [Time frame: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.]
- HRQoL change [Time frame: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.]
Secondary outcome measures (11)
- Pain-related fear [Time frame: Baseline as predictive factor.]
- Pain catastrophizing [Time frame: Baseline as predictive factor.]
- Neuropsychological change - general cognitive ability [Time frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
- Neuropsychological change - subjective cognitive ability [Time frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
- Neuropsychological change - processing speed [Time frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
- Neuropsychological change - working memory capacity [Time frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
- Neuropsychological change - executive control [Time frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
- HRV change [Time frame: Baseline,and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.]
- Objective sleep parameters change [Time frame: Baseline,and at the 2nd, and 24th week post-operative outpatient follow-up appointments.]
- Neurophysiological change_1 [Time frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
- Neurophysiological change_2 [Time frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Taiwan · 1 center
- Chang Gung Memorial Hospital — Taoyuan
Identifiers
NCT: NCT05917262 · 202202303B0