Clinical trial NCT06064474: Effects of High Ventilation Breathwork With Retention (HVBR) on Health
Official title: Effects of High Ventilation Breathwork With Retention (HVBR) on Mental Health and Wellbeing: A Randomised Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Anxiety
Depressive Symptoms
Mental Wellbeing
Positive Affect
Negative Affect
Sleep-Related Impairment
Lead sponsor: University of Sussex
Sponsor class: OTHER
Collaborators: name: Sylff Association
name: Brighton & Sussex Medical School
name: University of California, San Francisco
First posted: 2023-10-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are conducting a randomised-controlled trial comparing high ventilation breathwork with retention (HVBR) to a breathwork placebo (paced breathing at 15breaths/min with brief retentions). The metric of 15b/min aligns with guidance from the British Journal of Nursing, Royal College of Physicians and Johns Hopkins Medicine which state that the average, healthy rate should range from: 12-20, 12-18 and 12-16b/min, respectively. The main questions the study attempts to address are: Does HVBR lead to improved state and trait mental health and wellbeing in a general population adult sample?

The study will be conducted entirely online through the research platform Prolific, so participant data will be anonymous. The investigators will collect self-reports of mental health and wellbeing before and after the three-week breathwork period, in addition to a follow-up three weeks later. Pre-post intervention and follow-up questionnaires will be completed online via the survey platform Qualtrics which will be linked to Prolific. Data on self-reported adherence to, and credibility/expectancy of, the breathwork will also be collected, along with participants' experiences to gauge the safety and tolerability of the breathwork protocol.


Eligibility criteria: Inclusion Criteria (self-assessed):

* Fluent in English and living in the UK
* Have access to headphones
* Comfortable with faster breathing and holding breath
* Willing to only practice breathwork in safe environment, lying down in soft area (i.e., bed, sofa, carpet/mat), and always away from water \& hard ground
* Willing to only practice the breathwork away from large meals (i.e., before or 1hour after) and bedtime (i.e., at least 1 hour before if practicing in evening)

Exclusion Criteria (self-assessed):

* Hypotension or hypertension (low or high blood pressure)
* History of respiratory or cardiovascular/heart problems or disease
* History of fainting or syncope
* Epilepsy or seizures
* History of panic disorder or panic attacks
* Cerebral aneurysm
* Have had problems with prior breathwork sessions (i.e., fainting)
* Pregnancy, think one might be pregnant, trying to get pregnant, or are breastfeeding
* Any problems which affect one's ability to pace their breathing (i.e., active/chronic respiratory infection including blocked nose/cough/cold/fever, etc.), breathlessness, abnormally slow breathing (bradypnea), or abnormally fast breathing (tachypnoea)
* Any other physical/mental health conditions or current life events which impair or affect one's ability to engage in activities involving breath control
* Are taking any regular medication other than the contraceptive pill, including medications to reduce blood pressure (i.e., Ramipril or other ACE-inhibitors), beta blockers (i.e., Propranolol), antidepressants, anxiolytics or any other psychotropic medications

Primary outcomes:
measure: Subjective stress
timeFrame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention). Primary timepoint is post-intervention
Secondary outcomes:
measure: Subjective anxiety
timeFrame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)
measure: Subjective depressive symptoms
timeFrame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)
measure: Subjective mental wellbeing
timeFrame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)
measure: Subjective sleep-related impairment
timeFrame: Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)
measure: Subjective positive affect
timeFrame: Pre-intervention (immediately before the intervention), post first breathwork session (immediately after starting breathwork), and post-intervention (immediately after the intervention)
measure: Subjective negative affect
timeFrame: Pre-intervention (immediately before the intervention), post first breathwork session (immediately after starting breathwork), and post-intervention (immediately after the intervention)
measure: Subjective credibility and expectancy of protocol
timeFrame: Immediately after starting breathwork intervention
measure: Negative side effects due to protocol
timeFrame: Post-intervention (immediately after the intervention)
measure: Self-reported adherence to protocol
timeFrame: Post-intervention (immediately after the intervention)
Other outcomes:
measure: Overall experience
timeFrame: Post-intervention and follow-up (immediately after the intervention, and three weeks after the intervention)
measure: Hypothesis guessing
timeFrame: Follow-up (three weeks after the intervention)
Locations:
city: Remote/Online
country: United Kingdom
facility: Prolific
Study officials:
affiliation: University of Sussex
name: Guy W Fincham, MSc
role: PRINCIPAL_INVESTIGATOR
References: