Clinical trial NCT06368791: Anti-Stress Intervention Among Physicians Study
Official title: Evaluation of Easy-to-implement Anti-stress Interventions in a Series of N-of-1 Trials Among Physicians in Residence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Burnout, Psychological
Subjective Stress
Occupational Stress
Keywords: N-of-1 trial
Anti-stress Intervention
Box Breathing
Breathing
Mindfulness
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

* 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)

Primary outcomes:
measure: Daily perceived stress
timeFrame: daily on day 1 to day 28 of the study
measure: Daily expectation of perceived stress level on the following day
timeFrame: daily on day 1 to day 28 of the study
Secondary outcomes:
measure: Level of agreement between expected and actually perceived level of stress
timeFrame: daily on day 1 to day 28 of the study
measure: Compliance with the study protocol: number of participant reported outcomes
timeFrame: After 4 weeks
measure: Compliance with the study protocol: number of performed anti-stress interventions
timeFrame: After 4 weeks
measure: Successful study completion
timeFrame: After 4 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Valentin M Vetter, MD
role: PRINCIPAL_INVESTIGATOR
References: