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CompletedNCT06368791ASIPUpdated Dec 10, 2024

Anti-Stress Intervention Among Physicians Study

An interventional study of Box Breathing and Breathing and Mindfulness Exercise in Stress, Psychological, Burnout, Psychological and Subjective Stress, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-10.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
145
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stress, Psychological
  • Burnout, Psychological
  • Subjective Stress
  • Occupational Stress

Keywords

  • N-of-1 trial
  • Anti-stress Intervention
  • Box Breathing
  • Breathing
  • Mindfulness
03

In context

Occupational Stress

236 studies on the registry are indexed under Occupational Stress; 64 are open to participants now.

This study's enrollment of 145 is above the median of 89 across 167 interventional studies indexed under Occupational Stress.

Browse Occupational Stress studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria

  • 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
  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
145 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Box Breathing · Behavioral: Everyday life control

  • Experimental
    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.

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

Interventions

  • BehavioralBox 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.

    Also known as: Tactical Breathing

  • BehavioralBreathing 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.

  • BehavioralEveryday life control

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

06

What researchers measure

Primary outcomes

  1. 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?"

    Time frame: daily on day 1 to day 28 of the study

  2. 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?"

    Time frame: daily on day 1 to day 28 of the study

Secondary outcomes

  1. 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.

    Time frame: daily on day 1 to day 28 of the study

  2. Compliance with the study protocol: number of participant reported outcomes

    Compliance with the study protocol will be assessed by counting the number of participant reported outcomes documented.

    Time frame: After 4 weeks

  3. 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.

    Time frame: After 4 weeks

  4. 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.

    Time frame: After 4 weeks

07

Study locations

1 site
  • Charité - Universitätsmedizin Berlin
    Berlin, 10117, Germany
08

References and documents

Study documents

  • Statistical analysis plan · Aug 24, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06368791
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Valentin Max Vetter (Researcher, Charite University, Berlin, Germany) — Principal investigator
First posted
Apr 16, 2024
Start date
Apr 15, 2024
Primary completion
Jun 30, 2024
Completion
Oct 30, 2024
Last update
Dec 10, 2024

Study contacts

Valentin M Vetter, MD
principal investigator · Charite University, Berlin, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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