UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058654 |
|---|---|
| Receipt number | R000067075 |
| Scientific Title | Verification of the effects of VR-based modeling learning on the ethical sensitivity and ethical behavior of clinical nurses |
| Date of disclosure of the study information | 2025/09/25 |
| Last modified on | 2025/07/31 13:50:57 |
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Basic information
Public title
Verification of the effects of VR-based modeling learning on the ethical sensitivity and ethical behavior of clinical nurses
Acronym
VR ethics training for nurse practitioners
Scientific Title
Verification of the effects of VR-based modeling learning on the ethical sensitivity and ethical behavior of clinical nurses
Scientific Title:Acronym
VR ethics training for nurse practitioners
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to present ethical situations and desirable behavioral models in those situations using VR based on Bandura's social learning theory, the theory of modeling,and to verify changes in nurses' ethical sensitivity and ethical behavior through observation and verbalization. In addition, the study aims to compare the intervention group and the non-intervention group to clarify the effects of VR experiences on nurses' ethical sensitivity and behavior.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intergroup differences in ethical sensitivity scores measured by the Clinical Nurses' Ethical Sensitivity Scale between the non-intervention group two months after training and the intervention group two months after VR experience training.
Key secondary outcomes
Before attending the ethics training session: Revised Moral Sensitivity Scale (J-MSQ), Revised Scale for Nurses' Ethical Behavior,
Participant attributes: Age, gender, years of nursing experience, qualifications/degrees held, clinical ladder level, frequency of ethics-related consultations/interventions regarding ethical issues in the past month, and ethical issues discussed during the most recent ethics conference
Frequency of ethics conferences and whether consultation or intervention was requested when facing ethical issues, and recognition of the effectiveness of such consultation or intervention Immediately after the training session: Learning and impressions from the training session
After the VR experience: Learning and impressions from the VR experience, ease of understanding of the VR scenario and content, appropriateness of the VR story and information, quality of VR visuals and audio, and areas for improvement in the VR experience
Two months after training, six months after training: Revised Moral Sensitivity Scale (J-MSQ), Revised Nursing Ethics Behavior Scale, frequency of ethics conferences in the department over the past month, and whether consultations or intervention requests were made when facing ethical issues, as well as the perceived effectiveness of such consultations or interventions
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Non-intervention group: Only the conventional training program consisting of lectures and group work will be implemented.
Interventions/Control_2
Intervention group: In addition to the conventional training (lectures and group work), experiential training using VR (virtual reality) will be implemented as a new educational tool.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nurses aged 20 or older who are currently employed at Fukuoka University Hospital and are participating in training on nursing ethics as part of their continuing education.
Key exclusion criteria
Those who did not obtain consent from the individual to participate in this study.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Sakanashi |
| Middle name | |
| Last name | Sayori |
Organization
Fukuoka University
Division name
School of Nursing, Faculty of Medicine
Zip code
8140180
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka-shi, Fukuoka, 814-0180 JAPAN
TEL
0928011011
sakanashi@adm.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayori |
| Middle name | |
| Last name | Sakanashi |
Organization
Fukuoka University
Division name
School of Nursing, Faculty of Medicine
Zip code
8140180
Address
7-45-1, Nanakuma, Jonan-ku, Fukuoka-shi, Fukuoka, 814-0180 JAPAN
TEL
0928011011
Homepage URL
sakanashi@adm.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Sayori Sakanashi
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University
Address
School of Nursing, Faculty of Medicine
Tel
0928011011
fumed-ethics@fukuoka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 31 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067075
