HRV Biofeedback in Pain Patients (HRVB-PP)
|ClinicalTrials.gov Identifier: NCT02426476|
Recruitment Status : Active, not recruiting
First Posted : April 27, 2015
Last Update Posted : June 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Neuromuscular Pain||Behavioral: active heart rate variability biofeedback training Behavioral: sham HRVB training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||HRV Biofeedback in Pain Patients: Pilot Intervention for Pain, Fatigue & Sleep|
|Actual Study Start Date :||June 10, 2015|
|Actual Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: active HRVB training
Heart rate variability biofeedback training
Behavioral: active heart rate variability biofeedback training
resonant frequency breathing, attention focusing, positive emotional state
Other Name: a-HRVB
Sham Comparator: sham HRVB training
Behavioral: sham HRVB training
Other Name: s-HRVB
- Pain rating, measured with the Brief Pain Inventory (BPI) [ Time Frame: total time of participation is 16 weeks ]The BPI was developed by the World Health Organization (WHO) specifically for use among cancer patients, and it has since been widely adopted for assessment of clinical pain and pain treatment effectiveness in a variety of clinical and research settings.
- Preceived Stress Scale (PSS) [ Time Frame: total time of participation is 16 weeks ]
It measures the degree to which situations in one's life are appraised as stressful.
Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives.
- HRV Coherence [ Time Frame: total time of participation is 16 weeks ]HRV coherence will allow for direct, quantitative assessment of participant performance and receipt of intervention.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426476
|United States, South Carolina|
|Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC|
|Columbia, South Carolina, United States, 29209|
|Principal Investigator:||James B Burch||Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC|