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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое cognitive-behavioral pain psychoeducation
  The 20-minute psychoeducation session is a supportive session where behavioral coping strategies for pain management are discussed.

Первичные конечные точки

• Visual Analogue Scale change [Срок оценки: Baseline, immediately after training, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.]
• Shoulder function change_1 [Срок оценки: Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.]
• Shoulder function change_2 [Срок оценки: Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.]
• Subjective sleep quality change [Срок оценки: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.]
• Emotion-related measurements change [Срок оценки: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.]
• HRQoL change [Срок оценки: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.]

Вторичные конечные точки (11)

• Pain-related fear [Срок оценки: Baseline as predictive factor.]
• Pain catastrophizing [Срок оценки: Baseline as predictive factor.]
• Neuropsychological change - general cognitive ability [Срок оценки: Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
• Neuropsychological change - subjective cognitive ability [Срок оценки: Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
• Neuropsychological change - processing speed [Срок оценки: Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
• Neuropsychological change - working memory capacity [Срок оценки: Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
• Neuropsychological change - executive control [Срок оценки: Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
• HRV change [Срок оценки: Baseline,and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.]
• Objective sleep parameters change [Срок оценки: Baseline,and at the 2nd, and 24th week post-operative outpatient follow-up appointments.]
• Neurophysiological change_1 [Срок оценки: Baseline, and at the 24th week post-operative outpatient follow-up appointments.]
• Neurophysiological change_2 [Срок оценки: Baseline, and at the 24th week post-operative outpatient follow-up appointments.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 1 центр

• Chang Gung Memorial Hospital — Taoyuan

Идентификаторы

NCT: NCT05917262 · 202202303B0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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