Effects of Coherent Breathing Breathwork on Health

NCT ID: NCT05676658

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-22
• Study Completion Date: 2023-04-26

Brief Summary

The investigators are conducting a randomised-controlled trial comparing coherent breathing at ~5.5 breath cycles per minute-bcpm (with equal inhalation/exhalation durations of ~5.5secs each) to a well-designed placebo (paced breathing at 12bcpm with equal inhalation/exhalation durations of 2.5secs each). The metric of 12bcpm is in line with guidance from the British Journal of Nursing, Royal College of Physicians, and Johns Hopkins University which state that the average, healthy bcpm should range from: 12-20bcpm, 12-18bcpm, and 12-16bcpm, respectively, hence the investigators chose the minimum/lower bound for the active placebo control group. The main questions that our study attempts to address are: Does coherent breathing (and placebo coherent breathing) lead to improved 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 four-week breathwork period, along with a follow-up one-month later. Pre-post intervention and follow-up questionnaires will be completed online via the survey platform Qualtrics which will be linked to Prolific. Participants will also be asked how many times they practiced out of the assigned 28 days, to gauge self-reported adherence to the protocol. The investigators can then observe whether self-reported adherence correlates with changes in mental health and wellbeing, if any. Data on the self-reported credibility/expectancy of the breathwork randomly allocated to participants will also be collected, along with open-ended responses on participants' overall experience of the protocol/study.

Conditions

Stress; Anxiety; Depressive Symptoms; Wellbeing; Sleep Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Coherent breathing

Group Type: EXPERIMENTAL

Coherent breathing

Intervention Type: BEHAVIORAL

Guided audio of coherent breathing pre-recorded by trained breathwork facilitator: \~5.5bcpm (with equal inhalation/exhalation durations of \~5.5secs each) for \~10mins/day over four weeks / 28 days. Delivered remotely through audio link.

Placebo coherent breathing

Group Type: PLACEBO_COMPARATOR

Placebo coherent breathing

Intervention Type: BEHAVIORAL

Same audio of coherent breathing but paced at: \~12bcpm (with equal inhalation/exhalation durations of 2.5secs each) for \~10mins/day over four weeks / 28 days.

Interventions

Coherent breathing

Guided audio of coherent breathing pre-recorded by trained breathwork facilitator: \~5.5bcpm (with equal inhalation/exhalation durations of \~5.5secs each) for \~10mins/day over four weeks / 28 days. Delivered remotely through audio link.

Intervention Type: BEHAVIORAL

Placebo coherent breathing

Same audio of coherent breathing but paced at: \~12bcpm (with equal inhalation/exhalation durations of 2.5secs each) for \~10mins/day over four weeks / 28 days.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18+ years of age (18 is the automatic minimum age on Prolific)
• Able to breathe through nose
• Have access to headphones
• The following pre-screeners on Prolific will also be set so only those eligible on Prolific will see the study: Located/living in UK, Fluent in English, approval rate of 98% and at least 20 previous submissions (as recommended by Prolific to increase retention and reduce dropout rates in longitudinal and multi-part studies)

Exclusion Criteria

• Any problems which affect ones ability to pace their breathing (i.e., active/chronic respiratory infection including blocked nose/cough/cold/fever, etc.), breathlessness, cardiovascular problems, respiratory conditions or diseases (i.e., uncontrolled symptomatic asthma, COPD, lung cancer, etc.), abnormally slow breathing (bradypnea), or abnormally fast breathing (tachypnoea)
• Any other physical/mental health conditions or current life events which impair or affect ones ability to engage in activities involving breath control

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sylff Association

UNKNOWN

Sponsor Role: collaborator

University of Sussex

OTHER

Sponsor Role: lead

Responsible Party

Guy Fincham

Guy William Fincham

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guy W Fincham, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Sussex

Locations

Prolific

Remote/Online, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Sussex coherent breath study

Identifier Type: -

Identifier Source: org_study_id