Trial Outcomes & Findings for HRV Biofeedback in Pain Patients (NCT NCT02426476)

Last Updated: 2021-06-02

Results Overview

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. The possible range is 0 to 10; higher scores represent more pain interference.

Recruitment status

COMPLETED

Study phase

Target enrollment

116 participants

Primary outcome timeframe

Baseline, Week 15 (Follow-up Assessment)

Results posted on

2021-06-02

Participant Flow

3 patients provided informed consent and were randomized but did not show up for their baseline appointment

Participant milestones

Participant milestones
Measure	Active HRVB Training Heart rate variability biofeedback training active heart rate variability biofeedback training: resonant frequency breathing, attention focusing, positive emotional state	Sham HRVB Training passive relaxation sham HRVB training: passive relaxation
Overall Study STARTED	57	56
Overall Study COMPLETED	38	39
Overall Study NOT COMPLETED	19	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HRV Biofeedback in Pain Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active HRVB Training n=57 Participants Heart rate variability biofeedback training active heart rate variability biofeedback training: resonant frequency breathing, attention focusing, positive emotional state	Sham HRVB Training n=56 Participants passive relaxation sham HRVB training: passive relaxation	Total n=113 Participants Total of all reporting groups
Age, Continuous	54 years STANDARD_DEVIATION 10 • n=99 Participants	55 years STANDARD_DEVIATION 12 • n=107 Participants	54 years STANDARD_DEVIATION 11 • n=206 Participants
Sex: Female, Male Female	19 Participants n=99 Participants	18 Participants n=107 Participants	37 Participants n=206 Participants
Sex: Female, Male Male	38 Participants n=99 Participants	38 Participants n=107 Participants	76 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	34 Participants n=99 Participants	26 Participants n=107 Participants	60 Participants n=206 Participants
Race (NIH/OMB) White	15 Participants n=99 Participants	27 Participants n=107 Participants	42 Participants n=206 Participants
Race (NIH/OMB) More than one race	8 Participants n=99 Participants	3 Participants n=107 Participants	11 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	57 Participants n=99 Participants	56 Participants n=107 Participants	113 Participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline, Week 15 (Follow-up Assessment)

Outcome measures

Outcome measures
Measure	Active HRVB Training n=38 Participants Heart rate variability biofeedback training active heart rate variability biofeedback training: resonant frequency breathing, attention focusing, positive emotional state	Sham HRVB Training n=39 Participants passive relaxation sham HRVB training: passive relaxation
Pain Interference Rating, Measured With the Brief Pain Inventory (BPI) Baseline	7.2 score on a scale Interval 6.3 to 8.1	7.4 score on a scale Interval 6.3 to 8.4
Pain Interference Rating, Measured With the Brief Pain Inventory (BPI) Follow-up (week 15)	6.2 score on a scale Interval 5.2 to 7.2	6.9 score on a scale Interval 5.8 to 7.9

PRIMARY outcome

Timeframe: Baseline, Week 15 (Follow-up Assessment)

The perceived stress scale measures the degree to which situations in one's life are appraised as stressful. Higher values correspond to more stress. Items were designed to assess how unpredictable, uncontrollable, and overloaded respondents find their lives. The possible range is 0-40; higher values represent more stress.

Outcome measures

Outcome measures
Measure	Active HRVB Training n=38 Participants Heart rate variability biofeedback training active heart rate variability biofeedback training: resonant frequency breathing, attention focusing, positive emotional state	Sham HRVB Training n=39 Participants passive relaxation sham HRVB training: passive relaxation
Perceived Stress Scale (PSS) Baseline	22 units on a scale Interval 20.0 to 24.0	23 units on a scale Interval 21.0 to 25.0
Perceived Stress Scale (PSS) Follow-up (week 15)	20 units on a scale Interval 18.0 to 22.0	21 units on a scale Interval 19.0 to 24.0

PRIMARY outcome

Timeframe: Baseline, Week 15 (Follow-up Assessment)

Heart rate variability coherence will allow for direct, quantitative assessment of participant performance and receipt of intervention. The HRV Coherence Ratio is obtained by identifying the maximum peak in the 0.04-0.26 Hz range of the fast Fourier transformation of heart rate interbeat intervals, then calculating the integral in a window 0.030 Hz wide centered on the highest peak in that region ('peak power', usually \~0.1 Hz), then calculating the total power of the entire spectrum. The HRV Coherence Ratio is then quantified as: peak power / (total power - peak power).

Outcome measures

Outcome measures
Measure	Active HRVB Training n=38 Participants Heart rate variability biofeedback training active heart rate variability biofeedback training: resonant frequency breathing, attention focusing, positive emotional state	Sham HRVB Training n=39 Participants passive relaxation sham HRVB training: passive relaxation
Heart Rate Variability Coherence Ratio Baseline	0.18 Ratio Interval 0.13 to 0.25	0.17 Ratio Interval 0.12 to 0.25
Heart Rate Variability Coherence Ratio Follow-up (week 15)	0.52 Ratio Interval 0.36 to 0.76	0.20 Ratio Interval 0.13 to 0.3

Adverse Events

Active HRVB Training

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sham HRVB Training

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active HRVB Training n=57 participants at risk Heart rate variability biofeedback training active heart rate variability biofeedback training: resonant frequency breathing, attention focusing, positive emotional state	Sham HRVB Training n=56 participants at risk passive relaxation sham HRVB training: passive relaxation
Social circumstances HIPAA Authorization form	0.00% 0/57 • The project duration was ~4.5 years. Audits were performed annually.	1.8% 1/56 • Number of events 1 • The project duration was ~4.5 years. Audits were performed annually.

Other adverse events

Other adverse events
Measure	Active HRVB Training n=57 participants at risk Heart rate variability biofeedback training active heart rate variability biofeedback training: resonant frequency breathing, attention focusing, positive emotional state	Sham HRVB Training n=56 participants at risk passive relaxation sham HRVB training: passive relaxation
Social circumstances Consent form not signed by research staff	1.8% 1/57 • Number of events 1 • The project duration was ~4.5 years. Audits were performed annually.	3.6% 2/56 • Number of events 2 • The project duration was ~4.5 years. Audits were performed annually.

Additional Information

James Burch, MS, PhD, Professor

Columbia VA Health Care System, Virginia Commonwealth University, University of South Carolina

Phone: 803-404-1552

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place