Medical Education Intervention for Medical Students

Mental Health Clinical Trial

Official title:

Intervention to Promote Medical Students Empathy, Well-being and Study emotion-a Randomized Clinical Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02645643
• Other study ID #: MEI001
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 25, 2015
• Last updated: May 25, 2016
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: May 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Mental Health

Intervention

Other:
• Education of medical humanities
The medical students in the intervention group would gain education about the medical humanities, but not the control group.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ming Kuang	Sun Yat-sen University

References & Publications (3)

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. Epub 2007 Jul 26. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical students' empathy	we plan to use the scale"The Jefferson Scale of Physician Empathy" to measure medical students' empathy	3 months	No
Secondary	Medical students' burnout	we plan to use the scale"Maslach Burnout Inventory" to measure medical students' burnout	3 months	No
Secondary	Quality of life of Medical students	we plan to use the scale"MOS SF-8 Health Survey" to measure medical students' quality of life	3 months	No
Secondary	Medical students' self-efficiency	we plan to use the "General Self-Efficacy Scale" to measure medical students' self-efficiency	3 months	No
Secondary	Medical students' depression	we plan to use the "Patient Health Questionnaire-9" to measure medical students' depression	3 months	No