Anti-Stress Intervention Among Physicians Study

Not Applicable

Completed

• Conditions: Occupational Stress; Stress, Psychological; Burnout, Psychological; Subjective Stress
• Interventions: Behavioral: Breathing and Mindfulness Exercise; Behavioral: Box Breathing; Behavioral: Everyday life control

• Registration Number: NCT06368791
• Lead Sponsor: Charite University, Berlin, Germany

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:

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

Not available

Study Timeline

• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-11
• Study Start: 2024-04-15
• Study First Posted: 2024-04-16
• Primary Completion: 2024-06-30
• Study Completion: 2024-10-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Breathing and Mindfulness Exercise	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	Everyday life control	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.
Box Breathing	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	Everyday life control	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.

Primary Outcome Measures

Name	Time	Method
Daily perceived stress	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	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 Outcome Measures

Name	Time	Method
Compliance with the study protocol: number of participant reported outcomes	After 4 weeks	Compliance with the study protocol will be assessed by counting the number of participant reported outcomes documented.
Level of agreement between expected and actually perceived level of stress	daily on day 1 to day 28 of the study	By subtracting the expected from the actually experienced level of stress, the level of agreement will be assessed.
Compliance with the study protocol: number of performed anti-stress interventions	After 4 weeks	Compliance with the study protocol will be assessed by counting the number of anti-stress interventions completed over the entire duration of the study.
Successful study completion	After 4 weeks	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.

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany