Stress, PsychologicalASIPNCT06368791
Anti-Stress Intervention Among Physicians Study
A study testing Box Breathing and Breathing and Mindfulness Exercise in people with Stress, Psychological and Burnout, Psychological, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Burnout, Psychological, Subjective Stress
- What is being tested?
- Box Breathing and Breathing and Mindfulness Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2024to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Easy-to-implement Anti-stress Interventions in a Series of N-of-1 Trials Among Physicians in Residence
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:
Read more
- 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.
- 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.
- Being tested
- Box Breathing, Breathing and Mindfulness Exercise, Everyday life control
- Keywords
- N-of-1 trial, Anti-stress Intervention, Box Breathing, Breathing, Mindfulness
- Medical subject headings
- Stress, Psychological, Burnout, Psychological, Subjective Stress, Occupational Stress, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Box BreathingBehavioural
Also called Tactical 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 ExerciseBehavioural
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 controlBehavioural
Participants are instructed to not perform the anti-stress intervention and to proceed with their daily activities as usual.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Breathing and Mindfulness Exercise; Behavioral: Everyday life control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?"
Measured: 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?"
Measured: daily on day 1 to day 28 of the study
Secondary outcomes (4)
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.
Measured: daily on day 1 to day 28 of the study
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.
Measured: 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.
Measured: 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.
Measured: After 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start15 Apr 2024
- Primary completion30 Jun 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentin Max Vetter, Charite University, Berlin, Germany
- Investigators
- Valentin M Vetter, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368791
- Sponsor's protocol ID
- 30001479
- Acronym
- ASIP
- Status last verified
- Dec 2024
- First submitted
- 8 Apr 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Easy-to-implement Anti-stress Interventions in a Series of N-of-1 Trials Among Physicians in Residence
- ClinicalTrials.gov ID
- NCT06368791
- Acronym / sponsor ID
- ASIP / 30001479
- Keywords
- N-of-1 trial, Anti-stress Intervention, Box Breathing, Breathing, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Box Breathing | Experimental | Behavioral: Box Breathing, Behavioral: Everyday life controlIn 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. |
| Breathing and Mindfulness Exercise | Experimental | Behavioral: Breathing and Mindfulness Exercise, Behavioral: Everyday life controlIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Box BreathingAlso: Tactical BreathingParticipants 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. | Behavioural | Box Breathing |
| Breathing and Mindfulness ExerciseThe 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. | Behavioural | Breathing and Mindfulness Exercise |
| Everyday life controlParticipants are instructed to not perform the anti-stress intervention and to proceed with their daily activities as usual. | Behavioural | Box Breathing, Breathing and Mindfulness Exercise |
Primary outcome
Daily perceived stress
Time frame: 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
Time frame: 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?"
4 secondary outcomes
Level of agreement between expected and actually perceived level of stress
Time frame: daily on day 1 to day 28 of the study
Compliance with the study protocol: number of participant reported outcomes
Time frame: After 4 weeks
Compliance with the study protocol: number of performed anti-stress interventions
Time frame: After 4 weeks
Successful study completion
Time frame: After 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentin M Vetter, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Box Breathing and Breathing and Mindfulness Exercise in people with Stress, Psychological and Burnout, Psychological, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily perceived stress (time frame: daily on day 1 to day 28 of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.