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

May 21, 2026 updated by: Poyu Chen, Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:
          • ChihHao Chiu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness-based breathing
20-minute mindfulness-based breathing training
Behavioral: 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.
Experimental: HRV biofeedback
20-minute HRV biofeedback
Behavioral: 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.
Active Comparator: cognitive-behavioral pain psychoeducation
20-minute psychoeducation session
Behavioral: cognitive-behavioral pain psychoeducation
The 20-minute psychoeducation session is a supportive session where behavioral coping strategies for pain management are discussed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Shoulder function change_1
Time Frame: 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.
Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Shoulder function change_2
Time Frame: 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.
Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Subjective sleep quality change
Time Frame: 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.
Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Visual Analogue Scale change
Time Frame: 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.
Baseline, immediately after training, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Emotion-related measurements change
Time Frame: 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.
Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
HRQoL change
Time Frame: 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
Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain-related fear
Time Frame: Baseline as predictive factor.
Tampa scale of kinesiophobia. The lower TSK total scores means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia. Total scores range from 17 to 68 points.
Baseline as predictive factor.
Pain catastrophizing
Time Frame: Baseline as predictive factor.
Pain catastrophizing Scale (PCS). People are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness.
Baseline as predictive factor.
Neuropsychological change - processing speed
Time Frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Digit Symbol Coding. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time (e.g. 90 or 120 sec) is measured.
Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Neuropsychological change - working memory capacity
Time Frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Digit span Wechsler Memory Scale III (WMS-III). The test consists of two parts forward and backward span. The participant is asked to repeat the numbers read in one second intervals in the forward span in the same order. It assesses attention, concentration and short-term memory. In the backward span, the numbers read at one-second intervals are requested to be repeated in reverse order from the end to the beginning. Working memory, which is a component of executive functions, is evaluated. The highest score that can be obtained for the forward span is 8 points, and 7 for the backward span, for a total of 15 points.
Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Neuropsychological change - executive control
Time Frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Color Trails Test (CCT). The CCT is a cognitive assessment tool by connecting numbered circles and color in sequence.
Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Neurophysiological change_1
Time Frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Change in brain activity at rest.
Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Neurophysiological change_2
Time Frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Changes in Amplitude (μv) of EEG signals for event-related potential components.
Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Neuropsychological change - general cognitive ability
Time Frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Montreal Cognitive Assessment (MoCA) assesses general cognitive ability. The higher scores, the better the cognitive function. The total possible score is 0~30 points; a score of 26 or above is considered normal.
Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Neuropsychological change - subjective cognitive ability
Time Frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Everyday Cognition (Ecog-12) assesses subjective cognitive ability. The higher scores, the more subjective cognitive decline. The total possible score is 12~48 points; a score of 14 or above is considered as subjective decline.
Baseline, and at the 24th week post-operative outpatient follow-up appointments.
HRV change
Time Frame: Baseline,and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
HRV refers to the variation in time intervals between consecutive heartbeats by measuring the time duration between R-waves (peak of the QRS complex) on an electrocardiogram (ECG) signal. HRV parameters could be frequency-domain, including low-frequency (LF) and high-frequency (HF) power, and time-domain, including the root mean square of successive differences (RMSSD), and the standard deviation of the IBI of normal sinus beats (SDNN).
Baseline,and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Objective sleep parameters change
Time Frame: Baseline,and at the 2nd, and 24th week post-operative outpatient follow-up appointments.
Objective sleep parameters will be measured using the wearable device and sleep diary. These sleep parameters include sleep onset latency (SOL), total sleep time (TST), sleep efficiency (SE), and wake after sleep onset (WASO).
Baseline,and at the 2nd, and 24th week post-operative outpatient follow-up appointments.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cytokine
Time Frame: During surgery
Joint fluid or plasma will be obtained via aspiration from the shoulder joint of each patient at the beginning of the surgery.
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Science and Technology Council

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Chih-Hao Chiu, M.D., Chang Gung MH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202202303B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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