Comparing Mindfulness-based Breath Training and Heart Rate Variability Biofeedback for Shoulder Surgery Patients in the Postoperative Pain.
NCT ID: NCT05917262
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
120 participants
INTERVENTIONAL
2023-11-13
2026-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mindfulness-based breathing
20-minute mindfulness-based breathing training
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
20-minute HRV biofeedback
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
20-minute psychoeducation session
cognitive-behavioral pain psychoeducation
The 20-minute psychoeducation session is a supportive session where behavioral coping strategies for pain management are discussed.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* (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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Science and Technology Council
FED
Chang Gung Memorial Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Poyu Chen
Assistant professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chih-Hao Chiu, M.D.
Role: STUDY_CHAIR
Chang Gung MH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
ChihHao Chiu, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202202303B0
Identifier Type: -
Identifier Source: org_study_id