Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
145 participants
INTERVENTIONAL
2024-04-15
2024-10-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
Box Breathing
Participants are guided to find a quite and comfortable spot to sit and unwind. They are then directed to inhale deeply for four seconds, hold that breath for another four seconds, and then exhale slowly over four seconds. Following a brief four-second pause, they begin the next cycle of breathing. To assist with this exercise, participants will have access to a video featuring a red dot tracing a square pattern, moving at the pace needed for the breathing technique.
Everyday life control
Participants are instructed to not perform the anti-stress intervention and to proceed with their daily activities as usual.
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.
Breathing and Mindfulness Exercise
The second intervention involves a 10-minute session of guided breathing exercises that blend elements of mindfulness meditation with gentle body movements and controlled breathing. Participants are advised to find a quiet space, sit comfortably, and adopt an upright posture. They are then led through a series of brief exercises, incorporating mild stretches for the upper body and focused, mindful breathing.
Everyday life control
Participants are instructed to not perform the anti-stress intervention and to proceed with their daily activities as usual.
Interventions
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Box Breathing
Participants are guided to find a quite and comfortable spot to sit and unwind. They are then directed to inhale deeply for four seconds, hold that breath for another four seconds, and then exhale slowly over four seconds. Following a brief four-second pause, they begin the next cycle of breathing. To assist with this exercise, participants will have access to a video featuring a red dot tracing a square pattern, moving at the pace needed for the breathing technique.
Breathing and Mindfulness Exercise
The second intervention involves a 10-minute session of guided breathing exercises that blend elements of mindfulness meditation with gentle body movements and controlled breathing. Participants are advised to find a quiet space, sit comfortably, and adopt an upright posture. They are then led through a series of brief exercises, incorporating mild stretches for the upper body and focused, mindful breathing.
Everyday life control
Participants are instructed to not perform the anti-stress intervention and to proceed with their daily activities as usual.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
Yes
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Valentin Max Vetter
Researcher
Principal Investigators
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Valentin M Vetter, MD
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Charité - Universitätsmedizin Berlin
Berlin, , Germany
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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30001479
Identifier Type: -
Identifier Source: org_study_id