Anti-Stress Intervention Among Physicians (ASIP)

Overview
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Adverse effects of chronically high levels of stress on physical and mental health are well established. In physicians, the effects of elevated stress levels exceed the individual level and include treatment errors and reduced quality of patient-doctor relationships. Breathing and mindfulness-based exercises have been shown to reduce stress and could serve as an immediate and easy-to-implement anti-stress intervention among physicians. Due to the heterogeneity of their effect on stress, we aim to evaluate the intervention effect of performing a short daily breathwork-based or mindfulness-based intervention on the everyday level of perceived stress in physicians in residence in Germany in a series of N-of-1 trials.

Sponsor: This Trial Project is not associated with a Sponsor

SEEK ID: https://ldh.hpi.imise.uni-leipzig.de/projects/2

Public web page: https://studyu.health

NFDI4Health PIs: No PIs for this Trial Project

Trial Project created: 24th Oct 2024

Extended Metadata (Nfdi4Health MDS 3.3)

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Resource classification(*)

Type of the resource(*) : Study

Title(s)/name(s) of the Project

Title/name(*) : Evaluation of easy-to-implement anti-stress interventions in a series of N-of-1 trials: Study protocol of the Anti-Stress Intervention Among Physicians Study (ASIP)
Language of the title/name(*) : English

Acronym(s) of the Project

Acronym(*) : Anti-Stress Intervention Among Physicians (ASIP)
Language of the acronym(*) : English

Description(s) of the Project

Description(*) : Adverse effects of chronically high levels of stress on physical and mental health are well established. In physicians, the effects of elevated stress levels exceed the individual level and include treatment errors and reduced quality of patient-doctor relationships. Breathing and mindfulness-based exercises have been shown to reduce stress and could serve as an immediate and easy-to-implement anti-stress intervention among physicians. Due to the heterogeneity of their effect on stress, we aim to evaluate the intervention effect of performing a short daily breathwork-based or mindfulness-based intervention on the everyday level of perceived stress in physicians in residence in Germany in a series of N-of-1 trials.
Language of the description(*) : English

Keyword(s) describing the Project

Keyword(*) : n-of-1-trials

Keyword(*) : anti-stress

Keyword(*) : mental health

Language(s) of the project : German

Web page of the project : https://www.charite.de/service/klinische_studien_detail/item/studien_detail/asip/

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Creator/Author
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Intitute of Public Health (IPH), CC01, Charité
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Valentin
Family name(s)(*) : Vetter
Digital identifier(s)
Identifier(*) : 0000-0001-5003-7766
Scheme(*) : ORCID
Email address : valentin.vetter@charite.de
Phone number : +49 30 450 566 298
Organisation(s) associated with the contributor
Name(*) : Intitute of Public Health (IPH), CC01, Charité
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : 001w7jn25
Scheme(*) : ROR

Alternative identifiers

Type of the registry(*) : NCT (ClinicalTrials.gov)
Identifier(*) : NCT06368791

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Crossover
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Perceived stress
Terminology/classification(*) : ICD-10
Code of the health condition or disease : F43.9
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Mental and behavioural disorders (V)
On which diseases or conditions were the data collected? : Lower level ICD-10 (https://icd.who.int/browse10/2019/en), with autocomplete
Collects mortality data? : No
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Completed: Recruitment, data collection, and data quality management completed normally
Participants enrolled by invitation? : Yes
Start date : 15 April 2024
End date : 31 August 2024
Mono- or multicentric? : Monocentric
Number of centers : 1
One or more data providers? : One data provider
Number of data providers : 1
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : Male, Female, Diverse
Inclusion criteria : Physicians in training in Germany Weekly working time in medical activity of at least 9 hours Regular access to a smartphone 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 (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)
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : 6-minute box breathing exercise
Type of the intervention : Behavioral (e.g., psychotherapy, lifestyle counseling)
Additional information about the intervention : The first intervention, a 6-minute box breathing exercise, is used to reduce stress and is employed, for example, by law enforcement and the military to provide effective stress reduction in dangerous situations. Participants are instructed to take some time to relax and sit in a quiet and comforting place. They are then instructed to breathe in for four seconds, hold their breath for four seconds, and breathe out for another four seconds. After holding their breath for four seconds, the next breathing cycle starts. Participants will be provided with a video of a red dot following the outlines of a box at the required speed as a visual aid.
Name(s) of the arm(s) associated with the given intervention : Not specified
Name of the intervention(*) : 10-minute guided breathing exercise combining mindfulness meditation with simple body movements and breathwork
Type of the intervention : Behavioral (e.g., psychotherapy, lifestyle counseling)
Additional information about the intervention : Participants are instructed to sit in a quiet room and find an upright position. They are then guided through several short exercises that include light upper body stretching and mindful breathing.
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Overall, how stressful was your day?
Description of the outcome measure : Participants will be asked to answer the following two questions daily in the StudyU App on a visual analog scale from 1 (“not stressed at all”) to 10 (“extremely stressed out”)
Type of the outcome measure : Primary
Time point(s) of assessment : Not specified
Name of the outcome measure(*) : Which level of stress do you expect for the following day?
Description of the outcome measure : Participants will be asked to answer the following two questions daily in the StudyU App on a visual analog scale from 1 (“not stressed at all”) to 10 (“extremely stressed out”)
Type of the outcome measure : Primary
Time point(s) of assessment : Not specified
Name of the outcome measure(*) : The level of agreement between expected and actually perceived levels of stress, adherence to study protocol, and successful completion of the study (defined as reporting a minimally required number of PROs during phase 1 of the study)
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : Not specified
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : Physical activity
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Yes, there is a plan to make data available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Anonymously collected data will be made in part publicly available via research data repositories after study completion.
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : Not specified
Non-interventional aspects of the Project
Temporal design : Prospective
Target follow-up duration of the Project
Target follow-up duration(*) : 4
Unit of time(*) : Weeks
Number of follow-ups conducted : 1
Biosamples retained in a biorepository : None retained
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Other
Masking of intervention(s) assignment
Masking implemented? : false
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

Annotated Properties

Topic annotations

Psychiatry

Anti-Stress Intervention Among Physicians (ASIP)

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