Psychophysiological Effects of Controlled Respiration and Mindfulness (PECRM)
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ClinicalTrials.gov Identifier: NCT05304000 |
Recruitment Status :
Completed
First Posted : March 31, 2022
Last Update Posted : May 6, 2022
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | March 11, 2022 | |||||||||
First Posted Date ICMJE | March 31, 2022 | |||||||||
Last Update Posted Date | May 6, 2022 | |||||||||
Actual Study Start Date ICMJE | June 2, 2020 | |||||||||
Actual Primary Completion Date | September 17, 2020 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
Adherence to Protocol [ Time Frame: Daily from Day 1 to 28 ] Number of days subjects did their exercises out of the 28 days assigned
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Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
Current Other Pre-specified Outcome Measures |
Debriefing survey [ Time Frame: Day 29 (study endpoint) ] Open ended survey about how subjects would describe the protocols
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Original Other Pre-specified Outcome Measures | Same as current | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Psychophysiological Effects of Controlled Respiration and Mindfulness | |||||||||
Official Title ICMJE | Psychophysiological Effects of Controlled Respiration: Noninvasive Relaxation Techniques | |||||||||
Brief Summary | The investigators aim to understand the effectiveness of 3 types of breathwork exercises and a mindfulness meditation control on improving psychological and physiological measures of wellbeing. The interventions will be delivered remotely and effects are monitored through daily surveys and physiological monitoring with WHOOP wristband through a 28-day period. The information gained will help develop the most effective remote interventions for lowering stress and improving wellbeing. The study will be run on a healthy general population. The three breathing conditions were 1) Cyclic Sighing, which emphasizes relatively prolonged exhalations, 2) Box Breathing, which is equal duration of inhalations, breath retentions, exhalations and breath retentions, and 3) Cyclic Hyperventilation with Retention, with longer, more intense inhalations and shorter, passive exhalations. Mindfulness Meditation practice involved passive attention to breath. | |||||||||
Detailed Description | PRIMARY OBJECTIVES: I. Examine psychological and physiological effects of breathwork in general in comparison to mindfulness meditation. SECONDARY OBJECTIVES: I. Examine the effectiveness of specific breathwork protocols in improving mood and physiological wellness metrics in comparison to mindfulness meditation. OUTLINE: Of 140 potential participants who consented, 134 were randomized to the four interventions (3 were lost to follow-up and 3 were excluded due to lack of WHOOP straps at this stage). Out of the 134 that were randomized, 108 were enrolled. The primary reasons for attrition at this stage were due to pandemic-related reasons or loss of contact with the participants. From the 108 subjects enrolled, 24 were randomized into the Mindfulness Meditation control condition and 84 were randomized to the treatment conditions (30 Cyclic Sighing, 21 Box Breathing, 33 Cyclic Hyperventilation with Retention). The initial randomization consisted of a permuted block randomization design with a block size of eight. Both prior to and after the 28-day intervention, participants completed two brief questionnaires to assess the impact of the intervention on the daytime sequelae of sleep and anxiety: PROMIS Sleep Related Impairment - Short Form 8a, and the State-Trait Anxiety Questionnaire. Participants also completed a debriefing questionnaire at the end of the study. During the 28-day intervention period, participants did their assigned 5-minute exercise and completed two questionnaires before and after, the State Anxiety Inventory and the Positive and Negative Affect Schedule (PANAS). Participants received invitations to instructional videos (pre-recorded by Andrew D. Huberman) on the breathing exercises 3-5 days prior to the start of the study as well as daily text messages that reminded them to complete their exercises and pre-and-post-practice assessments. They were asked to complete the exercises only once a day. |
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Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Not Applicable | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized prospective Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Completed | |||||||||
Actual Enrollment ICMJE |
108 | |||||||||
Original Actual Enrollment ICMJE | Same as current | |||||||||
Actual Study Completion Date ICMJE | September 17, 2020 | |||||||||
Actual Primary Completion Date | September 17, 2020 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | Yes | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT05304000 | |||||||||
Other Study ID Numbers ICMJE | 41398 | |||||||||
Has Data Monitoring Committee | No | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | David Spiegel, Stanford University | |||||||||
Original Responsible Party | Same as current | |||||||||
Current Study Sponsor ICMJE | Stanford University | |||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||
Collaborators ICMJE | Not Provided | |||||||||
Investigators ICMJE |
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PRS Account | Stanford University | |||||||||
Verification Date | May 2022 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |