- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07355998
Medical Improvisation Study
Enhancing Communication and Cognitive Resilience in Surgical Trainees Through Medical Improvisation
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- UCSF
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Otolaryngology Resident at UCSF
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Improvisation Group
Otolaryngology Residents taking Improvisation Training
|
3 Online Group Improvisation Training classes led by a professional is offered every other week for 1 hour to the experimental cohort.
|
|
Active Comparator: Control Group
This control group of OHNS residents continues their standard medical education.
|
OHNS residents continue the existing standard medical education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Connection: Social Connectiveness Scale
Time Frame: 6 weeks
|
Team dynamics and interpersonal connectedness are assessed using the Social Connectedness Scale.
This is a custom survey developed specifically for this study to measure participants' sense of belonging and connection within the residency program.
The scale consists of 5 items rated on a 5-point Likert scale.
Total scores range from 0 to 25, with higher scores indicating a greater sense of connectedness (better outcome).
|
6 weeks
|
|
Clinical Decision Making Accuracy and Response Time
Time Frame: 6 weeks
|
Clinical decision-making under pressure is assessed using the "Intraoperative Vignettes" assessment.
This is a computer-based cognitive test comprising 20 Otolaryngology-Head and Neck Surgery (OHNS) case scenarios.
Participants are presented with clinical scenarios and must select the correct management decision.
The outcome is reported as a composite of accuracy (total number of correct responses) and response time (time taken to select an answer).
Accuracy is scored from 0 to 20, with higher scores indicating better clinical decision-making.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mood (PANAS)
Time Frame: 6 weeks
|
Mood is assessed using the Positive and Negative Affect Schedule (PANAS). This is a validated 20-item self-report questionnaire that measures two distinct dimensions of emotion: Positive Affect (10 items) and Negative Affect (10 items). Participants rate items on a 5-point scale ranging from 1 (Very slightly or not at all) to 5 (Extremely). Scores for each subscale range from 10 to 50.
|
6 weeks
|
|
Anxiety and Depression (DASS-21)
Time Frame: 6 weeks
|
Psychological distress is measured using the Depression, Anxiety, and Stress Scale-21 (DASS-21). This is a validated 21-item self-report instrument containing three subscales: Depression, Anxiety, and Stress (7 items per subscale). Participants rate how much each statement applied to them over the past week on a 4-point scale ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). Subscale scores are calculated by summing the scores for the relevant items and multiplying by 2.
|
6 weeks
|
|
Intervention Satisfaction Score (Intervention Arm Only)
Time Frame: 6 weeks
|
Participants in the intervention group complete an Intervention Satisfaction Survey to evaluate the curriculum and learner experience.
This measure utilizes a Likert scale to assess participant feedback.
Items are rated on a 5-point scale from 1 (Not true at all) to 5 (Completely true), with higher scores indicating higher satisfaction (better outcome).
|
6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Karen Barrett, PhD, University of California, San Francisco
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
Other Study ID Numbers
- 25-44724
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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