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

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Shoulder Pain; Pain, Postoperative

Treatments: Behavioral: Mindfulness-based breathing; Behavioral: HRV biofeedback; Behavioral: cognitive-behavioral pain psychoeducation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05917262

202202303B0

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Mindfulness-based breathing

Experimental group

Description:

20-minute mindfulness-based breathing training

Treatment:

Behavioral: Mindfulness-based breathing

HRV biofeedback

Experimental group

Description:

20-minute HRV biofeedback

Treatment:

Behavioral: HRV biofeedback

cognitive-behavioral pain psychoeducation

Active Comparator group

Description:

20-minute psychoeducation session

Treatment:

Behavioral: cognitive-behavioral pain psychoeducation