Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000297527
Ethics application status
Approved
Date submitted
30/09/2023
Date registered
21/03/2024
Date last updated
21/03/2024
Date data sharing statement initially provided
21/03/2024
Date results provided
21/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preliminary research of empathy education in medical students through virtual scenario experience
Scientific title
A randomized case-control study of empathy education in fifth-year and sixth-year medical students through different versions of virtual scenario experiences
Secondary ID [1] 311228 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 331644 0
empathy 331645 0
Condition category
Condition code
Public Health 328365 328365 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The virtual reality (VR) in the interventional group depicts a character as a depressed medical student and comprises three scenes. In the school setting, she wakes up from a nap, struggles to concentrate and take notes in her pharmacology course, and learns about her unsatisfactory test score during a post-class discussion. Feeling uneasy about the conversation, she avoids it, leading to inquiries from concerned classmates. This discomfort prompts her to ruminate on negative memories. The hospital scene portrays her helplessness as a doctor hurriedly asks questions. At home, she isolates herself, loses interest in playing the guitar, resorts to her cellphone for solace, and encounters distressing social news. Amid parental criticism, she hesitates to join friends for a reunion, ultimately contemplating a tragic decision and swallowing all her drugs. The VR utilizes an HTC VIVE Cosmos, developed with Unity 2019 software and connected to the VIVE device via Steam VR 2.6.1. The video's duration is 16:20 minutes, administered in a single session at the Chang Gung Memorial Hospital seminar room, supervised by investigators. A comparison with the control treatment reveals distinct elements in the intervention group, such as blurred faces, dim lighting, repeated internal monologue, and unattainable tasks designed to simulate characteristics of depression like inattention, a monotonous and boring life feeling, ruminating thoughts, and fatigue.
Intervention code [1] 327112 0
Behaviour
Comparator / control treatment
The virtual reality (VR) experience in the control group depicts a character in the role of a general medical student, unfolding across three distinct scenes. In the school environment, she attends a pharmacology course, participates in post-class discussions about test scores with classmates, and undergoes an introduction to examinations in medical college. The hospital scene introduces the concept of an internship. At home, her activities include playing the guitar, perusing social media on her cellphone, engaging in conversations with friends, and collaborating with classmates through a study group. The modality use and the location were as same as the intervention group. The video has a duration of 15:18 minutes, administered in a single session. A comparison between this group and the interventional treatment has previously been detailed in the description of intervention.
Control group
Active

Outcomes
Primary outcome [1] 336209 0
empathy
Timepoint [1] 336209 0
pre test: online questionnaire one week before the day of the experiment.
post test: the same day after VR experience, 1 hour after video was shown
Primary outcome [2] 336210 0
attitude toward depression
Timepoint [2] 336210 0
pre test: the same day after VR experience, 1 hour before video was shown
post test: the same day after VR experience, 1 hour after video was shown
Secondary outcome [1] 427339 0
emotional response towards VR experience
Timepoint [1] 427339 0
the same day after VR experience, 1 hour after video was shown
Secondary outcome [2] 427340 0
sense of embodiment in VR experience
Timepoint [2] 427340 0
the same day after VR experience, 1 hour after video was shown
Secondary outcome [3] 427341 0
the sense of immersion in VR
Timepoint [3] 427341 0
the same day after VR experience, 1 hour after video was shown
Secondary outcome [4] 427342 0
physical discomfort during the VR experience
Timepoint [4] 427342 0
the same day after VR experience, 1 hour after video was shown

Eligibility
Key inclusion criteria
fifth-year and sixth-year medical students of any gender from Chang Gung University
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
medical students who had previously trained in the psychiatry department.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/01/2021
Date of last participant enrolment
Anticipated
Actual
25/06/2021
Date of last data collection
Anticipated
Actual
15/04/2022
Sample size
Target
80
Accrual to date
Final
59
Recruitment outside Australia
Country [1] 25819 0
Taiwan, Province Of China
State/province [1] 25819 0
Taoyuan

Funding & Sponsors
Funding source category [1] 314928 0
Hospital
Name [1] 314928 0
Chang Gung Memorial Hospital Research Grants
Country [1] 314928 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Chang Gung Memorial Hospital
Address
Linkou Chang Gung Memorial Hospital, No. 5, Fuxing St, Guishan District, Taoyuan City, Taiwan 333
Country
Taiwan, Province Of China
Secondary sponsor category [1] 316933 0
None
Name [1] 316933 0
Address [1] 316933 0
Country [1] 316933 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313919 0
Institutional Review Board of Chang Gung Memorial Hospital (202001315B0D001)
Ethics committee address [1] 313919 0
Ethics committee country [1] 313919 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 313919 0
Approval date [1] 313919 0
01/01/2021
Ethics approval number [1] 313919 0
202001315B0D001

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129790 0
Dr Huang-Li Lin
Address 129790 0
Department of psychiatry, Rehabilitation building of Linkou Chang Gung Memorial Hospital, 3F, No. 5, Fuxing St, Guishan District, Taoyuan City, Taiwan 333
Country 129790 0
Taiwan, Province Of China
Phone 129790 0
+886 002 0975366304
Fax 129790 0
Email 129790 0
[email protected]
Contact person for public queries
Name 129791 0
Huang-Li Lin
Address 129791 0
Department of psychiatry, Rehabilitation building of Linkou Chang Gung Memorial Hospital, 3F, No. 5, Fuxing St, Guishan District, Taoyuan City, Taiwan 333
Country 129791 0
Taiwan, Province Of China
Phone 129791 0
+886 002 0975366304
Fax 129791 0
Email 129791 0
[email protected]
Contact person for scientific queries
Name 129792 0
Huang-Li Lin
Address 129792 0
Department of psychiatry, Rehabilitation building of Linkou Chang Gung Memorial Hospital, 3F, No. 5, Fuxing St, Guishan District, Taoyuan City, Taiwan 333
Country 129792 0
Taiwan, Province Of China
Phone 129792 0
+886 002 0975366304
Fax 129792 0
Email 129792 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20545Study protocol  [email protected]
20546Statistical analysis plan  [email protected]
20547Data dictionary  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.