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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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

Study 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

Primary outcome measure(s)

• Visual Analogue Scale change — Baseline, immediately after training, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
  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.
• Shoulder function change_1 — Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
  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.
• Shoulder function change_2 — Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
  Constant Score to measure the objective ROM. Scores range from 0 to 100 points, representing worst and best shoulder function, respectively.
• Subjective sleep quality change — Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
  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.
• Emotion-related measurements change — Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
  Hospital Anxiety and Depression Scale (HADS) to measure anxiety and depression in the medical setting. Higher scores indicate greater anxiety and depression.
• HRQoL change — Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
  EQ-5D-5L is a standardized measure of health-related quality of life. The higher transformed scores, the better HRQoL

Trial sites (1)

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