RecruitingNot Applicable

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

Taiwan120 participantsStarted 2023-11-13

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analogue Scale change

Timeframe: Baseline, immediately after training, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

Shoulder function change_1

Timeframe: Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

Shoulder function change_2

Timeframe: Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

Subjective sleep quality change

Timeframe: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

Emotion-related measurements change

Timeframe: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

HRQoL change

Timeframe: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

Trial details

NCT IDNCT05917262

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Poyu Chen, PhD

+886-3211-8800 poyuchen@gap.cgu.edu.tw

View on ClinicalTrials.gov More Pain, Postoperative trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Visual Analogue Scale change

Timeframe: Baseline, immediately after training, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

Shoulder function change_1

Timeframe: Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

Shoulder function change_2

Timeframe: Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

Subjective sleep quality change

Timeframe: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

Emotion-related measurements change

Timeframe: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

HRQoL change

Timeframe: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.