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临床试验/NCT06121596
NCT06121596已完成不适用

Relaxation Effects of Personalized Breathing Exercises for Healthy College Students: a Randomized Crossover Trial

Technical University of Munich2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
Relaxation Sum Score

研究概览

简要总结

Stress plays a major role in the etiology and pathogenesis of anxiety and depression. Relaxation therapies, such as breathing exercises, can reduce stress and increase relaxation.

This study has two aims. First, it aims to personalize and optimize breathing protocols. Second, it aims to tailor breathing protocols to subgroups based on prediction models of expected efficacy.

Three different breathing protocols, varying solely in their instructed breathing frequency with 40 percent (A), 60 percent (B), and 80 percent (C) of the interindividual spontaneous breathing frequency, are tested in a randomized, counterbalanced crossover trial. Other parameters, such as breathing quality (i.e., nasal and diaphragmatic), rhythm (i.e., prolonged exhalation without instructed pauses) and depth (i.e., increased depth due to slower breathing frequency) as well as contextual factors (e.g., posture, video-based instructions, type of pacer, etc.) are invariant between protocols.

First, this study hypothesizes a difference in the relaxation response between breathing protocols A, B, and C. This study looks at the relaxation response from three different angles (1) self-report, (2) autonomic arousal, and (3) central nervous system arousal. Second, this study explores prediction models of expected efficacy based on the interindividual variance in characteristics (i.e., depressive, anxious and stress symptoms as well as expertise in relaxation therapies) and biomarkers (e.g., heart rate variability, peripheral temperature, skin conductance, etc.). Prediction models can tailor breathing protocols to subgroups to increase expected efficacy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
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

入选标准

  • Above 18 years old
  • University student
  • Native German speaker

排除标准

  • Any psychiatric (e.g., anxiety), neurologic (e.g., epilepsy) or cardio-pulmonary (e.g., asthma) diagnosis

结局指标

主要结局

Relaxation Sum Score

时间窗: Immediately after each 5-minute breathing exercise

Measured with the German Version of the Relaxation State Questionnaire; Sum scores range from 10 to 50 (higher scores indicate greater relaxation).

次要结局

  • Current Perceived Stress Level(Immediately after each 5-minute breathing exercise)
  • Heart Rate Variability(During each 5-minute breathing exercise)
  • Peripheral Temperature(During each 5-minute breathing exercise)
  • Skin Conductance(During each 5-minute breathing exercise)
  • Power in Frequency Bands(During each 5-minute breathing exercise)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lukas Moebus

Principal Investigator

Technical University of Munich

研究点 (2)

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