RecruitingNot ApplicableNCT05917262

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

Sponsor

Chang Gung Memorial Hospital

Enrollment

120 participants

Start Date

Nov 13, 2023

Study Type

INTERVENTIONAL

Conditions

Pain, Postoperative Shoulder Pain

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This randomized study tests three mind-body techniques — mindfulness-based breathing, heart rate variability biofeedback, and cognitive behavioral pain education — to see which is most effective at reducing persistent pain after shoulder surgery. Some patients continue to experience pain even after successful shoulder operations, and this study explores psychological and physiological approaches to address that problem before surgery takes place. Eligible participants are adults with shoulder pain lasting at least 3 months, occurring at least 3 days per week, with pain severe enough to warrant surgery, and who have not had prior shoulder surgery in the last 3 years. Participation involves completing the assigned pre-operative mind-body program and follow-up pain and function assessments at 6 months. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMindfulness-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.

BEHAVIORALHRV 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.

BEHAVIORALcognitive-behavioral pain psychoeducation

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