Anti-Stress Intervention Among Physicians Study

NCT06368791 | Completed

• 1 other identifier: 30001479
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Stress, Psychological; Burnout, Psychological; Subjective Stress; Occupational Stress

Keywords

N-of-1 trial; Anti-stress Intervention; Box Breathing; Breathing; Mindfulness

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• 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 participant reported outcomes

  After 4 weeks

• Compliance with the study protocol: number of performed anti-stress interventions

  After 4 weeks

• Successful study completion

  After 4 weeks

Study Arms (2)

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.

Behavioral: Box Breathing; Behavioral: Everyday life control

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.

Behavioral: Breathing and Mindfulness Exercise; Behavioral: Everyday life control

Interventions

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.

Also known as: Tactical Breathing

Box Breathing

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.

Breathing and Mindfulness Exercise

Everyday life control BEHAVIORAL

Participants are instructed to not perform the anti-stress intervention and to proceed with their daily activities as usual.

Box Breathing; Breathing and Mindfulness Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Stress, Psychological; Burnout, Psychological; Subjective Stress; Occupational Stress; Respiratory Aspiration

Interventions

Respiration

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Occupational Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Valentin M Vetter, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 16, 2024
• Study Start: April 15, 2024
• Primary Completion: June 30, 2024
• Study Completion: October 30, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)