- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06875882
Evaluating Occupational Stress in Surgeons and Musicians: A Multi-modal Pilot Study Using Wearable EEG, Biomarker Analysis and Validated Questionnaires
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objectives • To assess the change in occupational stress among surgeons and musicians by measuring physiological and psychological stress markers.
Endpoints:
- Changes in salivary cortisol levels (before and after surgeries for surgeons and live public performances for musicians).
- Changes in State-Trait Anxiety Inventory-Short (STAI-S) scores (administered pre- and post-surgery/performance).
SECONDARY OBJECTIVES AND ENDPOINTS
• Assessing and comparing anxiety and burnout, based on the MBI, STAI-T, M-PAS, and SCAT, in surgeons and musicians
Endpoints:
- Baseline levels of anxiety and burnout measured using the MBI, M-PAS, STAI-T, and SCAT.
- Emotional exhaustion, depersonalization, and personal accomplishment from the MBI in both groups.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mei Rui, DMA
- Phone Number: (713) 597-1690
- Email: mrui@mdanderson.org
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- MD Anderson Cancer Center
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Contact:
- Mei Rui, DMA
- Phone Number: 713-597-1690
- Email: mrui@mdanderson.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 years and older
- Professional musicians (i.e., those with academic or orchestral appointments) or MD Anderson Neurosurgeons
- For Musicians only: You will have a musical performance within three months of study enrollment.
For Neurosurgeons only: You will perform a surgical procedure within three months of study enrollment.
Exclusion Criteria:
- Individuals who are unable to provide informed consent
- Individuals diagnosed with severe cognitive impairments, severe psychiatric disorders, or hearing or visual impairments that could affect participation
- Individuals previously enrolled in the study
- Non-English-speaking musicians and/or surgeons
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Occupational Stress
This research study is to learn about occupational stress among surgeons and musicians by integrating psychological assessments, neurophysiological measures, and biomarkers.
Researchers want to assess and compare factors associated with occupational stress, among surgeons and musicians, such as changes in stress biomarkers before and after surgery or music performance, anxiety, burnout, demographic factors, and brainwave activity linked to stress.
It is hoped the information learned in this study can be used to help promote better health outcomes and enhance the well-being of these workforce members.
Participants will undergo saliva sample collections and complete questionnaires before and after the performance or surgery.
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Participants will complete 5 questionnaires about participants demographics, burnout rates, and anxiety levels after participants consent to this study.
These questionnaires will be sent to participants via email and should take about 15-20 minutes to complete.
|
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Optional Procedure
Participants may optionally have a surgery or performance recorded and undergo an EEG while watching the recording.
These participants will undergo saliva sample collections and complete questionnaires before and after the EEG recording session.
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Participants will complete 5 questionnaires about participants demographics, burnout rates, and anxiety levels after participants consent to this study.
These questionnaires will be sent to participants via email and should take about 15-20 minutes to complete.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety and Adverse Events (AEs).
Time Frame: Through study completion; an average of 1 year.
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Through study completion; an average of 1 year.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mei Rui, DMA, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-1393
- NCI-2025-01927 (Other Identifier: NCI-CTRP Clinical Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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