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临床试验/NCT06368791
NCT06368791已完成不适用

Evaluation of Easy-to-implement Anti-stress Interventions in a Series of N-of-1 Trials Among Physicians in Residence

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Daily perceived stress

研究概览

简要总结

Medical practice often comes with high stress. Stress negatively affects our health and well-being and is linked to doctors making mistakes, some of which can be deadly.

In this study, the effect of two quick stress-relief methods on daily stress levels is estimated. The two anti-stress exercises are designed to easily fit into daily routines:

  1. Box breathing (6 minutes) is known to reduce stress and lower the heart rate. It is used by the military and law enforcement, among others, to manage stress.
  2. Breathing and mindfulness exercise (10 minutes): This guided breathing and mindfulness intervention combines mindful breathing with simple body movements, developed to reduce the perceived level of stress.

The effectiveness of these interventions is being examined in a series of N-of-1 trials. Each participant can choose between the interventions. After being randomly allocated to an individual sequence of one-week intervention and control phases, the study begins. Participants record their stress levels daily over the four-week study period. The intervention is only performed in the intervention phases. Upon completing the study, the stress levels during the intervention phases are compared to those in the control phases. Each participant will receive an individual analysis based on the collected data. In addition, the investigators will estimate the effects at the population level.

Three months after the study, a survey will be sent to the participants to check if the benefits have persisted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Daily perceived stress

时间窗: daily on day 1 to day 28 of the study

Participants are asked to answer the following question on an analog scale from 1 ("not at all") to 10 ("extremely"): "Overall, how stressful was your day?"

Daily expectation of perceived stress level on the following day

时间窗: daily on day 1 to day 28 of the study

Participants are asked to answer the following question on an analog scale from 1 ("not at all") to 10 ("extremely"): "Which level of stress do you expect for the following day?"

次要结局

  • Compliance with the study protocol: number of participant reported outcomes(After 4 weeks)
  • Level of agreement between expected and actually perceived level of stress(daily on day 1 to day 28 of the study)
  • Compliance with the study protocol: number of performed anti-stress interventions(After 4 weeks)
  • Successful study completion(After 4 weeks)

研究者

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

Valentin Max Vetter

Researcher

Charite University, Berlin, Germany

研究点 (2)

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