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Effects of High Ventilation Breathwork With Retention (HVBR) on Health

Primary Purpose

Stress, Anxiety, Depressive Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High ventilation breathwork with retention (HVBR)
Placebo HVBR
Sponsored by
University of Sussex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ProlificRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

High ventilation breathwork with retention (HVBR)

Placebo HVBR

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Subjective stress
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 Outcome Measures

Subjective anxiety
DASS-21 - anxiety subscale (score range: 0-21; higher scores denote worse outcome)
Subjective depressive symptoms
DASS-21 - depression subscale (score range: 0-21; higher scores denote worse outcome)
Subjective mental wellbeing
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) (score range: 7 to 35; higher scores denote better outcome). Total raw scores are then transformed into metric scores using the SWEMWBS conversion table on: www.warwick.ac.uk
Subjective sleep-related impairment
PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 4a (score range: 5-20; higher scores denote worse outcome). Data scored using a T-score transformation according to PROMIS Sleep scoring manual on: www.healthmeasures.net
Subjective positive affect
Positive and Negative Affect Schedule (PANAS) positive affect subscale (score range: 10-50; higher scores denote better outcome)
Subjective negative affect
PANAS negative affect subscale (score range: 10-50; higher scores denote worse outcome)
Subjective credibility and expectancy of protocol
Credibility/Expectancy Questionnaire (CEQ-6). Two Sets (Credibility of course/therapy [breathwork] and expectancy of course/therapy [breathwork]). Four items scored 1-9 and two items scored 0-100%. Scores for expectancy set then standardised via converting them to z-scores. Higher scores denote greater credibility and/or expectancy of specific breathwork technique
Negative side effects due to protocol
Whether participants experienced unpleasant/unwanted short-term effects and/or lasting bad effects from the breathwork
Self-reported adherence to protocol
Number of sessions participants self-report practicing out of 21 days assigned

Full Information

First Posted
September 26, 2023
Last Updated
October 13, 2023
Sponsor
University of Sussex
Collaborators
Sylff Association, Brighton & Sussex Medical School, University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT06064474
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2023 (Actual)
Primary Completion Date
December 13, 2023 (Anticipated)
Study Completion Date
December 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sussex
Collaborators
Sylff Association, Brighton & Sussex Medical School, University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anxiety, Depressive Symptoms, Mental Wellbeing, Positive Affect, Negative Affect, Sleep-Related Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High ventilation breathwork with retention (HVBR)
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo HVBR
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
High ventilation breathwork with retention (HVBR)
Intervention Description
Intervention
Intervention Type
Behavioral
Intervention Name(s)
Placebo HVBR
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Subjective stress
Description
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
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
Secondary Outcome Measure Information:
Title
Subjective anxiety
Description
DASS-21 - anxiety subscale (score range: 0-21; higher scores denote worse outcome)
Time Frame
Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)
Title
Subjective depressive symptoms
Description
DASS-21 - depression subscale (score range: 0-21; higher scores denote worse outcome)
Time Frame
Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)
Title
Subjective mental wellbeing
Description
Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) (score range: 7 to 35; higher scores denote better outcome). Total raw scores are then transformed into metric scores using the SWEMWBS conversion table on: www.warwick.ac.uk
Time Frame
Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)
Title
Subjective sleep-related impairment
Description
PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 4a (score range: 5-20; higher scores denote worse outcome). Data scored using a T-score transformation according to PROMIS Sleep scoring manual on: www.healthmeasures.net
Time Frame
Pre-post intervention and follow-up (immediately before the intervention, immediately after the intervention, and three weeks after the intervention)
Title
Subjective positive affect
Description
Positive and Negative Affect Schedule (PANAS) positive affect subscale (score range: 10-50; higher scores denote better outcome)
Time Frame
Pre-intervention (immediately before the intervention), post first breathwork session (immediately after starting breathwork), and post-intervention (immediately after the intervention)
Title
Subjective negative affect
Description
PANAS negative affect subscale (score range: 10-50; higher scores denote worse outcome)
Time Frame
Pre-intervention (immediately before the intervention), post first breathwork session (immediately after starting breathwork), and post-intervention (immediately after the intervention)
Title
Subjective credibility and expectancy of protocol
Description
Credibility/Expectancy Questionnaire (CEQ-6). Two Sets (Credibility of course/therapy [breathwork] and expectancy of course/therapy [breathwork]). Four items scored 1-9 and two items scored 0-100%. Scores for expectancy set then standardised via converting them to z-scores. Higher scores denote greater credibility and/or expectancy of specific breathwork technique
Time Frame
Immediately after starting breathwork intervention
Title
Negative side effects due to protocol
Description
Whether participants experienced unpleasant/unwanted short-term effects and/or lasting bad effects from the breathwork
Time Frame
Post-intervention (immediately after the intervention)
Title
Self-reported adherence to protocol
Description
Number of sessions participants self-report practicing out of 21 days assigned
Time Frame
Post-intervention (immediately after the intervention)
Other Pre-specified Outcome Measures:
Title
Overall experience
Description
Participants' perspectives and overall experience of the protocol/study-period
Time Frame
Post-intervention and follow-up (immediately after the intervention, and three weeks after the intervention)
Title
Hypothesis guessing
Description
Whether participants can correctly guess which condition they were allocated to
Time Frame
Follow-up (three weeks after the intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guy W Fincham, MSc
Phone
+44 (0)1273 876638
Email
g.fincham@sussex.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Cavanagh, PhD
Phone
+44 (0)1273 876638
Email
kate.cavanagh@sussex.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy W Fincham, MSc
Organizational Affiliation
University of Sussex
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prolific
City
Remote/Online
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy W Fincham

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All participant data will be anonymous (only Prolific user IDs will be seen). No identifiable personal information will be collected. Participants will be able to check a box if they are happy for our research team at the University of Sussex to include the data again in future studies related to breathwork and meditation, as well as share with other research groups, if these have gained independent ethical approval, based on the strict confidentiality terms described in the participant info/consent form.
IPD Sharing Time Frame
Indefinitely after the study has been completed.
IPD Sharing Access Criteria
Our research team at the University of Sussex will have access. The datasets used and/or analysed during the current study will be available from the principal investigator on reasonable request to other researchers working on breathwork and meditation.

Learn more about this trial

Effects of High Ventilation Breathwork With Retention (HVBR) on Health

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