- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05699382
Improvement Mental Health Among Physicians by a Mindfulness-training Mobile Application
January 25, 2023 updated by: yonatan butbul MD, Rambam Health Care Campus
Improvement in Mental Health Markers Among Hospital Physicians Through a Mindfulness-training Mobile Application - Randomized Controlled Trial
The aim of our study was to evaluate the effect of a short, smartphone-based mindfulness application on stress, wellbeing and burnout among hospital physicians
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Physicians working at a tertiary hospital were recruited and randomly divided into two groups, a study group (SG) in which participants practiced mindfulness through the application for 6 weeks and a control group (CG).
Main Measures: All participants filled-out questionnaires assessing stress (Perceived Stress Scale-PSS), mental health (Mental Health Inventory-MHI) and burnout (Maslach Burnout Inventory-MBI) at baseline and 7 weeks later
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Haifa, Israel
- Pediatric rheumatology clinic, Rambam Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
* Physicians Working full-time at the Rambam Healthcare Campus.
Exclusion Criteria:
* Physicians that won't be able to participate in at least 50% of the practicing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: a study group (SG) in which participants practiced mindfulness through the application for 6 weeks
|
Physicians working at a tertiary hospital were recruited and randomly divided into two groups, a study group (SG) in which participants practiced mindfulness through the application for 6 weeks
|
No Intervention: control group
Waiting for the intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale-PSS
Time Frame: 7 weeks
|
Differences in stress between baseline and 7 weeks later - will be assessed by Perceived Stress Scale-PSS
|
7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental Health Inventory-MHI
Time Frame: 7 weeks
|
Differences in Mental health between baseline and 7 weeks later will be assessed by Mental Health Inventory-MHI
|
7 weeks
|
Maslach Burnout Inventory - MBI
Time Frame: 7 weeks
|
Differences in Burn out between baseline and 7 weeks later will be assessed by Maslach Burnout Inventory - MBI
|
7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yonatan Butbul, Rambam
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
December 1, 2022
Study Registration Dates
First Submitted
January 16, 2023
First Submitted That Met QC Criteria
January 25, 2023
First Posted (Estimate)
January 26, 2023
Study Record Updates
Last Update Posted (Estimate)
January 26, 2023
Last Update Submitted That Met QC Criteria
January 25, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 0150-20-RMB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Will be available on request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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