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Clinical Trials/NCT06064474
NCT06064474
Completed
Not Applicable

Effects of High Ventilation Breathwork With Retention (HVBR) on Mental Health and Wellbeing: A Randomised Placebo-controlled Trial

University of Sussex1 site in 1 country200 target enrollmentOctober 13, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
University of Sussex
Enrollment
200
Locations
1
Primary Endpoint
Subjective stress
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 13, 2023
End Date
December 11, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Guy Fincham

Principal Investigator

University of Sussex

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Subjective stress

Time Frame: 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

Secondary Outcomes

  • 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))

Study Sites (1)

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