BREATHE study (Biofeedback Reactivity and Awareness To HEalth)
Research type
Research Study
Full title
BREATHE feasibility study (Biofeedback Reactivity and Awareness To HEalth): The effect of biofeedback and mindfulness breathing on blood pressure and psychological wellbeing
IRAS ID
324891
Contact name
Pankaj Gupta
Contact email
Sponsor organisation
UHL Sponsor
Clinicaltrials.gov Identifier
https://doi.org/10.17605/OSF.IO/JY32C, OSF
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Summary of Research
Hypertension is a global issue affecting 1.28 billion people worldwide (WHO, 2023) and is a preventable risk factor for stroke and death. Uncontrolled blood pressure is a serious health issue that needs to be addressed. Medication alone is not always sufficient to control blood pressure, with other approaches needed. It is crucial that patients are able to control their blood pressure to reduce the risk of health complications and premature death. Research suggests that biofeedback is a potentially viable option for patients with hypertension and anxiety.
Biofeedback is an intervention where a person receives feedback on their physiological responses e.g., heart rate in relation to activities. For example, a person looks at their heart rate via the Fitbit, practices breathing practice, then looks again at the Fitbit for their heart rate to see how it has changed. The “biofeedback” is the device’s feedback to show how an activity can affect the person’s heart rate. It acts like positive reinforcement, showing how an activity can improve their heart rate.
We will look at the effect of biofeedback in patients with uncontrolled blood pressure and prescribed multiple anti-hypertensive medications. The intervention group will practice biofeedback with breathing at home for three months using a Fitbit. The control group will have a hypertension educational session and wear the Fitbit for three months but will receive no guidance about biofeedback or breathing. This will compare Fitbit + breathing biofeedback vs Fitbit alone.
The will be a pilot study, trialling the intervention and study design before expanding it into a larger RCT. We will recruit 40 participants. If the intervention is successful, it will provide an additional therapy option for people who struggle to take medication or do not experience the desired effects of blood pressure (e.g., blood pressure control).
Summary of Results
This study was a feasibility study to assess a breathing and biofeedback based intervention for patients with hypertension. The study aimed to assess if this was a feasible intervention for this population group.
Of note, the study had difficulty recruiting participants to the study. This was partly due to the reliance on clinical staff recruiting during clinic time, and a stringent recruitment criteria.
Of the participants that were recruited, there were drop outs or lost to follow ups that affected the ability to assess the feasibility of the study.
This study was closed early due to the low recruitment. The feasibility study found that the recruitment style was not feasible for a larger study, and was an important finding to establish for other studies in the area.
The results and learning from this study will be written up into a paper to share the learning.
REC name
North of Scotland Research Ethics Committee 2
REC reference
24/NS/0027
Date of REC Opinion
26 Mar 2024
REC opinion
Further Information Favourable Opinion