Evaluation of Easy-to-implement Anti-stress Interventions in a Series of N-of-1 Trials Among Physicians in Residence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Daily perceived stress
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Daily perceived stress
Time Frame: 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
Time Frame: 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?"
Secondary Outcomes
- 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)
Investigators
Valentin Max Vetter
Researcher
Charite University, Berlin, Germany