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临床试验/NCT05304000
NCT05304000已完成不适用

Psychophysiological Effects of Controlled Respiration: Noninvasive Relaxation Techniques

Stanford University2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2020年6月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
2
主要终点
Respiratory Rate

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Not pregnant
  • •Able to follow basic instruction for prescreen and scheduling
  • •Compliant with investigator instructions during the consent process and participation in the study

排除标准

  • •Non-English speaking
  • •Anyone with personality disorders or psychosis such as schizoaffective disorder
  • •Demonstrates evidence of severe psychiatric disorder in prescreen or email contact (as judged by Dr. Spiegel)
  • •History of seizures
  • •Heart disease (based on PI's clinical judgement, dependent on the severity of the symptoms)
  • •Current untreated psychosis, or bipolar disorder, or substance/alcohol abuse/dependence (based on PI's clinical judgement, dependent on the severity of the symptoms)
  • •Any Medical condition that could be exasperated by study participation (based on PI's clinical judgement)
  • •Non USA mailing address to receive the WHOOP strap
  • •Vision or hearing impairment severe enough to interfere with study participation,

研究组 & 干预措施

Mindfulness Meditation

Active Comparator

5 minutes a day of mindfulness meditation practice for 28 days (passive attention to breath) delivered remotely through a video link.

干预措施: Mindfulness Meditation (Behavioral)

Cyclic Sighing Breathing

Experimental

5 minutes a day of active breathwork practice for 28 days delivered remotely through a video link. The protocol consists of slow inhales until lungs felt full then one more inhale to maximally fill the lungs, followed up a slow exhale. Repeat this cycle for 5 minutes.

干预措施: Cyclic Sighing Breathing (Behavioral)

Box Breathing

Experimental

5 minutes a day of active breathwork practice for 28 days delivered remotely through a video link. The protocol consists of equal duration of inhale, hold, exhale, hold cycles. The duration of the cycle is determined by the participant's comfort level with holding. (e.g. 4 sec inhale, 4 sec hold, 4 sec exhale, 4 sec hold). Repeat this cycle for 5 minutes.

干预措施: Box Breathing (Behavioral)

Cyclic Hyperventilation with Retention

Experimental

5 minutes a day of active breathwork practice for 28 days delivered remotely through a video link. The protocol consists of 30 breaths (inhale deeply through the nose and exhale passively through the mouth) and after those 30 breaths, to exhale all their air via their mouth and to calmly wait with lungs empty for 15 seconds. Repeat this cycle for 5 minutes.

干预措施: Cyclic Hyperventilation with Retention (Behavioral)

结局指标

主要结局

Respiratory Rate

时间窗: Daily from Day 1 to 28

Daily obtained from WHOOP wrist band

State Anxiety

时间窗: Daily from Day 0 to 29

STAI State Trait Anxiety

Trait Anxiety

时间窗: Day 0 and Day 29 (Baseline and Endpoint)

STAI State Trait Anxiety

Negative Affect

时间窗: Daily from Day 1 to 28

PANAS Negative Affect

Change in number of hours of sleep

时间窗: Daily from Day 1 to 28

Daily obtained from WHOOP wrist band as Hours of Sleep. Changes in the hours of sleep will be assessed with more hours indicating better sleep.

Change in the ratio of number of hours of sleep to hours in bed

时间窗: Daily from Day 1 to 28

Obtained daily from WHOOP wrist band as sleep efficiency. Changes in the Whoop Sleep Efficiency score will be assessed with higher score (ratio) indicating higher sleep efficiency.

Positive Affect

时间窗: Daily from Day 1 to 28

PANAS Positive Affect

Heart Rate Variability

时间窗: Daily from Day 1 to 28

Daily obtained from WHOOP wrist band

Sleep Duration

时间窗: Daily from Day 1 to 28

Daily obtained from WHOOP wrist band

Daytime Sleep Related Disturbance

时间窗: Day 0 and Day 29 (Baseline and Endpoint)

PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a PROMIS Sleep Related Impairment Short Form 8a

Resting Heart Rate

时间窗: Daily from Day 1 to 28

Daily obtained from WHOOP wrist band

次要结局

  • Adherence to Protocol(Daily from Day 1 to 28)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Spiegel

Professor, Department of Psychiatry and Behavioral Sciences, Stanford University

Stanford University

研究点 (2)

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