Evaluation of Easy-to-implement Anti-stress Interventions in a Series of N-of-1 Trials Among Physicians in Residence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 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:
- 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.
- 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
- 是
入选标准
- •Physicians in training in Germany
- •Weekly working time in medical activity of at least 9 hours
- •Regular access to a mobile phone on which the "StudyU"-App can be installed
- •Informed consent
排除标准
- •Age <18 years
- •Specialist training already completed
- •No clinical activity during the study period or part of the study period (e.g. vacation, research activity, etc.)
- •Participation in another intervention study during the study period
- •Does not speak German
- •Does yoga more than 4 times a month
- •Meditates or performs breathing exercises on average more than 4 days per month
- •Confirmed or suspected pregnancy
- •Presence of a psychiatric disorder
- •Presence of cardiovascular disease
- •Presence of respiratory or pulmonary disease
- •Presence of a neurological disease
- •Substance abuse (for example, alcohol, drugs, or other)
- •Planned surgery within the next 6 months
- •Doctor's recommendation (or self-assessment) not to perform mindfulness or breathing exercises
- •Lack of informed consent
- •Employee of the Charité - Universitätsmedizin Berlin (due to data protection reasons, employees of the Charité - Universitätsmedizin Berlin will not be included in this study)
研究组 & 干预措施
Box Breathing
In the intervention phase of the N-of-1 trial participants are instructed to perform box breathing intervention. During the control phase of the N-of-1 trial, participants are instructed to proceed with their daily activities as usual without engaging in the anti-stress intervention.
干预措施: Box Breathing (Behavioral)
Box Breathing
In the intervention phase of the N-of-1 trial participants are instructed to perform box breathing intervention. During the control phase of the N-of-1 trial, participants are instructed to proceed with their daily activities as usual without engaging in the anti-stress intervention.
干预措施: Everyday life control (Behavioral)
Breathing and Mindfulness Exercise
In the intervention phase of the N-of-1 trial participants are instructed to perform the guided breathing and mindfulness exercise. During the control phase of the N-of-1 trial, participants are instructed to proceed with their daily activities as usual without engaging in the anti-stress intervention.
干预措施: Breathing and Mindfulness Exercise (Behavioral)
Breathing and Mindfulness Exercise
In the intervention phase of the N-of-1 trial participants are instructed to perform the guided breathing and mindfulness exercise. During the control phase of the N-of-1 trial, participants are instructed to proceed with their daily activities as usual without engaging in the anti-stress intervention.
干预措施: Everyday life control (Behavioral)
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
Valentin Max Vetter
Researcher
Charite University, Berlin, Germany