Pain, PostoperativeNCT05917262
Comparing Mindfulness-based Breath Training and Heart Rate Variability Biofeedback for Shoulder Surgery Patients in the Postoperative Pain.
A study testing Mindfulness-based breathing, HRV biofeedback and cognitive-behavioral pain psychoeducation in people with Pain, Postoperative and Shoulder Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Shoulder Pain
- What is being tested?
- Mindfulness-based breathing, HRV biofeedback and cognitive-behavioral pain psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Nov 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
ChihHao Chiu, PhD
About this study
Official title: 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.
- Conditions
- Pain, Postoperative, Shoulder Pain
- Being tested
- Mindfulness-based breathing, HRV biofeedback, cognitive-behavioral pain psychoeducation
- Keywords
- Shoulder pain, Postoperative pain, mindfulness, HRV, biofeedback
- Medical subject headings
- Pain, Postoperative, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based breathingBehavioural
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 biofeedbackBehavioural
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 psychoeducationBehavioural
The 20-minute psychoeducation session is a supportive session where behavioral coping strategies for pain management are discussed.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based breathing | Experimental | 20-minute mindfulness-based breathing training Receives: Behavioral: Mindfulness-based breathing |
| HRV biofeedback | Experimental | 20-minute HRV biofeedback Receives: Behavioral: HRV biofeedback |
| cognitive-behavioral pain psychoeducation | Active comparator | 20-minute psychoeducation session Receives: Behavioral: cognitive-behavioral pain psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale change
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.
Measured: Baseline, immediately after training, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Shoulder function change_1
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.
Measured: Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Shoulder function change_2
Constant Score to measure the objective ROM. Scores range from 0 to 100 points, representing worst and best shoulder function, respectively.
Measured: Baseline, and at the 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Subjective sleep quality change
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.
Measured: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Emotion-related measurements change
Hospital Anxiety and Depression Scale (HADS) to measure anxiety and depression in the medical setting. Higher scores indicate greater anxiety and depression.
Measured: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
HRQoL change
EQ-5D-5L is a standardized measure of health-related quality of life. The higher transformed scores, the better HRQoL
Measured: Baseline, and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Secondary outcomes (11)
Pain-related fear
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.
Measured: Baseline as predictive factor.
Pain catastrophizing
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.
Measured: Baseline as predictive factor.
Neuropsychological change - general cognitive ability
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.
Measured: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Neuropsychological change - subjective cognitive ability
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.
Measured: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Neuropsychological change - processing speed
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.
Measured: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Neuropsychological change - working memory capacity
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.
Measured: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Neuropsychological change - executive control
Color Trails Test (CCT). The CCT is a cognitive assessment tool by connecting numbered circles and color in sequence.
Measured: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
HRV change
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).
Measured: Baseline,and at the 2nd, 6th, 12th, and 24th week post-operative outpatient follow-up appointments.
Objective sleep parameters change
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).
Measured: Baseline,and at the 2nd, and 24th week post-operative outpatient follow-up appointments.
Neurophysiological change_1
Change in brain activity at rest.
Measured: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Neurophysiological change_2
Changes in Amplitude (μv) of EEG signals for event-related potential components.
Measured: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start13 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council
- Responsible party
- Principal investigator, Poyu Chen, Chang Gung Memorial Hospital
- Investigators
- Chih-Hao Chiu, M.D., Study chair, Chang Gung MH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917262
- Sponsor's protocol ID
- 202202303B0
- Status last verified
- May 2026
- First submitted
- 17 May 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05917262
- Acronym / sponsor ID
- 202202303B0
- Conditions
- Pain, Postoperative, Shoulder Pain
- Keywords
- Shoulder pain, Postoperative pain, mindfulness, HRV, biofeedback
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based breathing | Experimental | Behavioral: Mindfulness-based breathing20-minute mindfulness-based breathing training |
| HRV biofeedback | Experimental | Behavioral: HRV biofeedback20-minute HRV biofeedback |
| cognitive-behavioral pain psychoeducation | Active comparator | Behavioral: cognitive-behavioral pain psychoeducation20-minute psychoeducation session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based breathingThe 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. | Behavioural | Mindfulness-based breathing |
| HRV biofeedbackThe 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. | Behavioural | HRV biofeedback |
| cognitive-behavioral pain psychoeducationThe 20-minute psychoeducation session is a supportive session where behavioral coping strategies for pain management are discussed. | Behavioural | cognitive-behavioral pain psychoeducation |
Primary outcome
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.
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.
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.
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.
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.
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
11 secondary outcomes
Pain-related fear
Time frame: Baseline as predictive factor.
Pain catastrophizing
Time frame: Baseline as predictive factor.
Neuropsychological change - general cognitive ability
Time frame: 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.
Neuropsychological change - processing speed
Time frame: 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.
Neuropsychological change - executive control
Time frame: 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.
Objective sleep parameters change
Time frame: Baseline,and at the 2nd, and 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.
Neurophysiological change_2
Time frame: Baseline, and at the 24th week post-operative outpatient follow-up appointments.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chih-Hao Chiu, M.D. study chair
Chang Gung MH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based breathing, HRV biofeedback and cognitive-behavioral pain psychoeducation in people with Pain, Postoperative and Shoulder Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Poyu Chen, PhD (+886-3211-8800 ext. 5449, poyuchen@gap.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.