Mental HealthPhase 3NCT02645643
Medical Education Intervention for Medical Students
A Phase 3 study testing Education of medical humanities in people with Mental Health, run by Ming Kuang.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Education of medical humanities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1 age 18 to 25 years
- 2 junior students majoring in clinical medicine
- 3 no mental diseases previously
Who cannot join
- Did not meet inclusion criteria
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health
- Being tested
- Education of medical humanities
- Keywords
- medical students, professionalism, medical education, study emotion
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education of medical humanitiesOther
The medical students in the intervention group would gain education about the medical humanities, but not the control group.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Medical students rolled into this group would accept education of medical humanities. Receives: Other: Education of medical humanities |
| control group | No intervention | Medical students rolled into this group would not gain education of medical humanities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical students' empathy
we plan to use the scale"The Jefferson Scale of Physician Empathy" to measure medical students' empathy
Measured: 3 months
Secondary outcomes (4)
Medical students' burnout
we plan to use the scale"Maslach Burnout Inventory" to measure medical students' burnout
Measured: 3 months
Quality of life of Medical students
we plan to use the scale"MOS SF-8 Health Survey" to measure medical students' quality of life
Measured: 3 months
Medical students' self-efficiency
we plan to use the "General Self-Efficacy Scale" to measure medical students' self-efficiency
Measured: 3 months
Medical students' depression
we plan to use the "Patient Health Questionnaire-9" to measure medical students' depression
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming Kuang
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor-investigator, Ming Kuang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645643
- Sponsor's protocol ID
- MEI001
- Status last verified
- May 2016
- First submitted
- 25 Dec 2015
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20841531Reed 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.
PubMed 21952063Chen 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.
PubMed 17653807Rong 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.
PubMed 34246265
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Promote Medical Students Empathy, Well-being and Study emotion-a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02645643
- Acronym / sponsor ID
- MEI001
- Conditions
- Mental Health
- Keywords
- medical students, professionalism, medical education, study emotion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ming KuangUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Education of medical humanitiesMedical students rolled into this group would accept education of medical humanities. |
| control group | No intervention | –Medical students rolled into this group would not gain education of medical humanities. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1 age 18 to 25 years
- 2 junior students majoring in clinical medicine
- 3 no mental diseases previously
Key exclusion criteria (1 listed)
- Did not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education of medical humanitiesThe medical students in the intervention group would gain education about the medical humanities, but not the control group. | Other | intervention group |
Primary outcome
Medical students' empathy
Time frame: 3 months
we plan to use the scale"The Jefferson Scale of Physician Empathy" to measure medical students' empathy
4 secondary outcomes
Medical students' burnout
Time frame: 3 months
Quality of life of Medical students
Time frame: 3 months
Medical students' self-efficiency
Time frame: 3 months
Medical students' depression
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Background: PubMed 20841531Schwenk 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.
- Background: PubMed 21952063Reed 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.
- Background: PubMed 17653807Chen 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.
- Derived from this study: PubMed 34246265Rong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Education of medical humanities in people with Mental Health, run by Ming Kuang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical students' empathy (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02645643, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.