Effects of High Ventilation Breathwork With Retention (HVBR) on Mental Health and Wellbeing: A Randomised Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Subjective stress
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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)
排除标准
- •(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
研究组 & 干预措施
High ventilation breathwork with retention (HVBR)
Guided audio of HVBR pre-recorded by a trained breathwork facilitator for ~20min/day over 21 days (three weeks). Delivered remotely through audio link, comprising evocative music and four rounds of hyperventilation with four separate retentions (breath holds), progressively increasing in length (from ~45seconds up to ~90 seconds).
干预措施: High ventilation breathwork with retention (HVBR) (Behavioral)
Placebo HVBR
Guided audio of placebo HVBR pre-recorded by a trained breathwork facilitator for ~20min/day over 21 days (three weeks). Delivered remotely through audio link, comprising music and four rounds of paced breathing at 15b/min (equal inhale:exhale) with four separate brief retentions, progressively increasing in length (from ~10secs to ~25secs).
干预措施: Placebo HVBR (Behavioral)
结局指标
主要结局
Subjective stress
时间窗: 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
Depression Anxiety Stress Scale-21 (DASS-21) - stress subscale (score range: 0-21; higher scores denote worse outcome). Score on DASS-21 then multiplied by two to convert it to the longer form DASS-42 final score
次要结局
- Subjective anxiety(Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention))
- Subjective sleep-related impairment(Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention))
- Subjective depressive symptoms(Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention))
- Subjective mental wellbeing(Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention))
- Subjective positive affect(Pre-intervention (immediately before the intervention), post first breathwork session (immediately after starting breathwork), and post-intervention (immediately after the intervention))
- Negative side effects due to protocol(Post-intervention (immediately after the intervention))
- Subjective negative affect(Pre-intervention (immediately before the intervention), post first breathwork session (immediately after starting breathwork), and post-intervention (immediately after the intervention))
- Subjective credibility and expectancy of protocol(Immediately after starting breathwork intervention)
- Self-reported adherence to protocol(Post-intervention (immediately after the intervention))
研究者
Guy Fincham
Principal Investigator
University of Sussex