Psychophysiological Effects of Controlled Respiration: Noninvasive Relaxation Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 4
- 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,
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.
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
Positive Affect
时间窗: Daily from Day 1 to 28
PANAS Positive Affect
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
David Spiegel
Professor, Department of Psychiatry and Behavioral Sciences, Stanford University
Stanford University