Psychophysiological Effects of Controlled Respiration and Mindfulness : Psychophysiological Effects of Controlled Respiration: Noninvasive Relaxation Techniques
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..
Medienart: |
Klinische Studie |
---|
Erscheinungsjahr: |
2022 |
---|---|
Erschienen: |
2022 |
Enthalten in: |
ClinicalTrials.gov - (2022) vom: 06. Mai Zur Gesamtaufnahme - year:2022 |
---|
Sprache: |
Englisch |
---|
Links: |
Volltext [kostenfrei] |
---|
Themen: |
610 |
---|
Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: March 31, 2022, Last downloaded: ClinicalTrials.gov processed this data on May 10, 2022, Last updated: May 12, 2022 |
---|
Study ID: |
NCT05304000 |
---|---|
Veröffentlichungen zur Studie: |
|
fisyears: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
CTG00830873X |
---|
LEADER | 01000caa a22002652 4500 | ||
---|---|---|---|
001 | CTG00830873X | ||
003 | DE-627 | ||
005 | 20230425191004.0 | ||
007 | cr uuu---uuuuu | ||
008 | 220406s2022 xx |||||o 00| ||eng c | ||
035 | |a (DE-627)CTG00830873X | ||
035 | |a (UBBS_Klinische_Studien)NCT05304000 | ||
035 | |a (UBBS_Klinische_Studien)41398 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
245 | 1 | 0 | |a Psychophysiological Effects of Controlled Respiration and Mindfulness |b Psychophysiological Effects of Controlled Respiration: Noninvasive Relaxation Techniques |
264 | 1 | |c 2022 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a Computermedien |b c |2 rdamedia | ||
338 | |a Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: March 31, 2022, Last downloaded: ClinicalTrials.gov processed this data on May 10, 2022, Last updated: May 12, 2022 | ||
520 | |a 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. | ||
650 | 2 | |a Sleep Initiation and Maintenance Disorders | |
650 | 4 | |a Medical Condition: Stress, Physiological, Stress, Emotional, Insomnia | |
650 | 4 | |a Study Type: Interventional | |
650 | 4 | |a Recruitment Status: Completed | |
650 | 4 | |a 610 | |
773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2022) vom: 06. Mai |
773 | 1 | 8 | |g year:2022 |g day:06 |g month:05 |
856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT05304000 |z kostenfrei |3 Volltext |
912 | |a GBV_CTG | ||
912 | |a SSG-OLC-PHA | ||
951 | |a AR | ||
952 | |j 2022 |b 06 |c 05 |