UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051406 |
|---|---|
| Receipt number | R000058645 |
| Scientific Title | Development and Educational Impact Analysis of a Virtual Reality Material for Simulating Physical Restraints: A Qualitative Investigation Using SCAT for Nursing Exercises Implemented with Nursing Students |
| Date of disclosure of the study information | 2023/06/21 |
| Last modified on | 2023/06/21 17:30:51 |
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Basic information
Public title
Development and Educational Impact Analysis of a Virtual Reality Material for Simulating Physical Restraints
Acronym
Development and Educational Impact Analysis of a Virtual Reality Material for Simulating Physical Restraints
Scientific Title
Development and Educational Impact Analysis of a Virtual Reality Material for Simulating Physical Restraints: A Qualitative Investigation Using SCAT for Nursing Exercises Implemented with Nursing Students
Scientific Title:Acronym
Development and Educational Impact Analysis of a Virtual Reality Material for Simulating Physical Restraints: A Qualitative Investigation Using SCAT for Nursing Exercises Implemented with Nursing Students
Region
| Japan |
Condition
Condition
The intervention subjects were healthy third-year nursing college students.
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to analyze the experiences of students who participated in an exercise utilizing VR materials on physical restraints in psychiatric nursing education through SCAT analysis, and to identify model stories of common learning experiences.
The specific research question was, "What is the general learning experience of the simulated experience of physical restraint using VR materials? The specific research question is "What are the general learning experiences that simulated experiences of physical restraints using VR teaching materials bring about?
The significance of this study is to clarify how VR materials affect the learning experience of students in psychiatric nursing education. This will provide a path toward devising more effective nursing practice utilizing VR materials.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
The open-ended questionnaire was administered as a web-based questionnaire using an online form after the lecture. In addition to the basic attributes, participants were asked to write freely about "what they felt through the physical restraint experience" and "what they learned from the physical restraint experience. During data collection, a password was set on the data to prevent unrelated persons from viewing the data for security purposes. After data collection, the data in the online form were immediately deleted to leave no traces on the Web. Peer debriefings were conducted by a group of researchers to ensure that there were no biases in interpretation or oversight in the content of the questionnaire.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The exercise simulating physical restraints in psychiatric nursing was conducted as a single 90-minute lecture. The content of the exercise consisted of the following three parts
(1) Lecture: Theoretical background of physical restraints and their actual use in the field were explained.
(2) Viewing of VR educational materials: Students were asked to wear a VR headset and lie on a bed in the nursing practice room. The nursing practice was a simulated experience, and the students were not actually restrained. The researcher asked the students to lie on the bed assuming that their body movements would be restricted, and provided them with an opportunity to understand the effects of physical restraints on patients by viewing the VR educational materials (viewed for approximately 20 minutes via a dedicated application using a smart phone).
(3) Debriefing: Students were divided into small groups and exchanged opinions about their experiences and impressions gained through the VR materials. A faculty member participated in each group as a facilitator.
Interventions/Control_2
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
| 21 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The participants in this study were nursing students who had earned psychiatric nursing credits and had not yet experienced practical training.
Key exclusion criteria
Exclusion criteria for this study were (1) those with hypersensitivity to mental stimuli, (2) those with claustrophobia, (3) those with mental illness and inpatients, and (4) those who were uncomfortable with VR.
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | SHO |
| Middle name | |
| Last name | Nagai |
Organization
University of Human Environment
Division name
School of Nursing
Zip code
4740035
Address
3-220 Ebata-cho, Obu-shi, Aichi, Japan
TEL
0562430701
s-nagai@uhe.ac.jp
Public contact
Name of contact person
| 1st name | SHO |
| Middle name | |
| Last name | Nagai |
Organization
University of Human Environment
Division name
School of Nursing
Zip code
4740035
Address
3-220 Ebata-cho, Obu-shi, Aichi, Japan
TEL
0562430701
Homepage URL
s-nagai@uhe.ac.jp
Sponsor or person
Institute
University of Human Environment
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
University of Human Environment
Address
3-220 Ebata-cho, Obu-shi, Aichi, Japan
Tel
0562430701
s-nagai@uhe.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
| 2023 | Year | 06 | Month | 21 | 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
17
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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 08 | 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
| 2023 | Year | 06 | Month | 21 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058645
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