UMIN-CTR Clinical Trial

Basic information
Public title	Development of VR teaching materials that simulate seclusion in a psychiatric ward
Acronym	Learning Effectiveness of VR Materials
Scientific Title	Development of VR teaching materials that simulate seclusion in a psychiatric ward
Scientific Title:Acronym	Learning Effectiveness of VR Materials
Region	Japan

Condition
Condition	psychiatric disease
Classification by specialty	Psychiatry Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study analyzes students' experiences of exercises using VR materials that simulate isolation in psychiatric nursing education.
Basic objectives2	Others
Basic objectives -Others	Examine the learning effect of the simulated experience by VR teaching materials on the experience of the parties concerned.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Study participants were asked to view a VR video simulating isolation during nursing practice for approximately 10 minutes and to complete an open-ended questionnaire (web-based questionnaire) about their experience.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 course is designed for students who have completed the credits required for psychiatric nursing practice and who have not yet gone on to psychiatric nursing practice.
Key exclusion criteria	Exclusion criteria for this study were (1) hypersensitivity to mental stimuli, (2) claustrophobia, and (3) those who were in the hospital for mental illness, and they were asked to refrain from participating in the study.
Target sample size	15

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
Email	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
Email	s-nagai@uhe.ac.jp

Sponsor
Institute	University of Human Environment School of Nursing
Institute
Department

Funding Source
Organization	self-procurement
Organization
Division
Category of Funding Organization	Self funding
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
Email	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	2022 Year 11 Month 26 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 05 Month 01 Day
Date of IRB	2022 Year 07 Month 06 Day
Anticipated trial start date	2022 Year 08 Month 01 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

The open-ended questionnaire was administered via a web-based questionnaire using an online form after the lecture. The questionnaire took about 20 to 30 minutes to complete. In addition to the basic attributes, the participants were asked to write freely about (1) the lecture, (2) their experience of listening to the VR materials, and (3) what they learned from the experience of debriefing in small groups of students.

Management information
Registered date	2022 Year 11 Month 25 Day
Last modified on	2022 Year 11 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056505