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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Box Breathing | Experimental | 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. |
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| Breathing and Mindfulness Exercise | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Box Breathing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily perceived stress | 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 on day 1 to day 28 of the study |
| Daily expectation of perceived stress level on the following day | 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?" | daily on day 1 to day 28 of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Level of agreement between expected and actually perceived level of stress | By subtracting the expected from the actually experienced level of stress, the level of agreement will be assessed. | daily on day 1 to day 28 of the study |
| Compliance with the study protocol: number of participant reported outcomes |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Valentin M Vetter, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 24, 2024 | Sep 1, 2024 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D000077062 | Burnout, Psychological |
| D000097844 | Subjective Stress |
| D000073397 | Occupational Stress |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009784 | Occupational Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D012119 | Respiration |
| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| Breathing and Mindfulness Exercise | Behavioral | 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 | Behavioral | Participants are instructed to not perform the anti-stress intervention and to proceed with their daily activities as usual. |
|
Compliance with the study protocol will be assessed by counting the number of participant reported outcomes documented. |
| After 4 weeks |
| Compliance with the study protocol: number of performed anti-stress interventions | Compliance with the study protocol will be assessed by counting the number of anti-stress interventions completed over the entire duration of the study. | After 4 weeks |
| Successful study completion | Successful completion of the study will be assessed based on the minimum required number of results reported by participants during the study period to be included in the final statistical analysis. | After 4 weeks |
| D012140 |
| Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |