- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02645643
Medical Education Intervention for Medical Students
May 25, 2016 updated by: Ming Kuang
Intervention to Promote Medical Students Empathy, Well-being and Study emotion-a Randomized Clinical Trial.
The doctor-patient relationship was becoming worse.
More and more work-related violence has happened to physicians and nurses.
A portion of medical students felt depressed and thought that the career future was gloomy.
The study was designed to measure the empathy, an vital element of professionalism, well-being of mental and study emotion.
Furthermore, the investigators explored an intervention of group study to promote medical students' professionalism, mental health and study emotion.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
A total number of 200 junior medical students are going to be enrolled according to inclusive criteria.
They are divided into two groups, one group is given education about medical humanities when the other group is not given any intervention but the same room and time.The outcomes including empathy, depression, quality of life, burnout and self-efficiency are measured before, during and after the trial.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 3
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
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 1 age 18 to 25 years
- 2 junior students majoring in clinical medicine
- 3 no mental diseases previously
Exclusion Criteria:
- Did not meet inclusion criteria
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group
Medical students rolled into this group would accept education of medical humanities.
|
The medical students in the intervention group would gain education about the medical humanities, but not the control group.
|
|
No Intervention: control group
Medical students rolled into this group would not gain education of medical humanities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medical students' empathy
Time Frame: 3 months
|
we plan to use the scale"The Jefferson Scale of Physician Empathy" to measure medical students' empathy
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medical students' burnout
Time Frame: 3 months
|
we plan to use the scale"Maslach Burnout Inventory" to measure medical students' burnout
|
3 months
|
|
Quality of life of Medical students
Time Frame: 3 months
|
we plan to use the scale"MOS SF-8 Health Survey" to measure medical students' quality of life
|
3 months
|
|
Medical students' self-efficiency
Time Frame: 3 months
|
we plan to use the "General Self-Efficacy Scale" to measure medical students' self-efficiency
|
3 months
|
|
Medical students' depression
Time Frame: 3 months
|
we plan to use the "Patient Health Questionnaire-9" to measure medical students' depression
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Schwenk TL, Davis L, Wimsatt LA. Depression, stigma, and suicidal ideation in medical students. JAMA. 2010 Sep 15;304(11):1181-90. doi: 10.1001/jama.2010.1300.
- Reed DA, Shanafelt TD, Satele DW, Power DV, Eacker A, Harper W, Moutier C, Durning S, Massie FS Jr, Thomas MR, Sloan JA, Dyrbye LN. Relationship of pass/fail grading and curriculum structure with well-being among preclinical medical students: a multi-institutional study. Acad Med. 2011 Nov;86(11):1367-73. doi: 10.1097/ACM.0b013e3182305d81.
- Chen D, Lew R, Hershman W, Orlander J. A cross-sectional measurement of medical student empathy. J Gen Intern Med. 2007 Oct;22(10):1434-8. doi: 10.1007/s11606-007-0298-x. Epub 2007 Jul 26.
- Rong R, Chen W, Dai Z, Gu J, Chen W, Zhou Y, Kuang M, Xiao H. Improvement of the management of mental well-being and empathy in Chinese medical students: a randomized controlled study. BMC Med Educ. 2021 Jul 10;21(1):378. doi: 10.1186/s12909-021-02813-6.
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
December 1, 2015
Primary Completion (Anticipated)
September 1, 2016
Study Completion (Anticipated)
September 1, 2016
Study Registration Dates
First Submitted
December 25, 2015
First Submitted That Met QC Criteria
January 4, 2016
First Posted (Estimate)
January 5, 2016
Study Record Updates
Last Update Posted (Estimate)
May 26, 2016
Last Update Submitted That Met QC Criteria
May 25, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- MEI001
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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