Randomized Controlled TrialNCT06605781
Enhancing Psychiatric Nursing Skills in Auditory Hallucination Assessment Via AR/VR and Virtual OSCE
A study testing AR/VR technology-based training and traditional vedio and discussion group in people with Randomized Controlled Trial, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The purpose of this study is to develop and evaluate AI-based virtual reality teaching resources aimed at enhancing nursing students' competencies in assessing, communicating with, and managing patients experiencing auditory hallucinations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Randomized Controlled Trial
- What is being tested?
- AR/VR technology-based training and traditional vedio and discussion group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Sep 2024to Jul 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nursing students who are about to undertake their psychiatry practicum.
- Those who are willing to join the study and sign the consent form.
- Those who are willing to bring a smartphone to connect with VR360 and watch the video.
- Those who are willing to use their smartphone for research purposes (a smartphone will be provided by the research team if needed).
Who cannot join
- Individuals with hearing or vision impairments
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Yang Ming Chiao Tung University
Taipei, Taipei City, 112304
Chiu Yueh Yang, PhD, +8862-2826-7388, cyyang3@ym.edu.tw
Mu Hsi Young, MS, +886972-102-204, deborahyounglulu33@gmail.com
About this study
Official title: Enhancing Auditory Hallucination Assessment and Intervention Skills of Psychiatric Nursing Student Through AR/VR Technology and OSCE in Virtual Clinical Environments
The purpose of this study is to develop and evaluate AI-based virtual reality teaching resources aimed at enhancing nursing students' competencies in assessing, communicating with, and managing patients experiencing auditory hallucinations. Specifically, this study seeks to improve the ability of nursing students to effectively assess auditory hallucinations, facilitate better communication with patients experiencing such disturbances, and strengthen their skills in managing these symptoms through the implementation of virtual reality-based educational scenarios.
Read the detailed description
This study employs a quasi-experimental design and uses a convenience sampling method to select senior students from a university nursing program as participants. The study aims to recruit 150 nursing students. The research involves two institutions, with participants being divided into groups within each institution. The students will be randomly assigned by computer into two groups: an experimental group and a control group. The experimental group will receive AR/VR technology-based group training within a virtual clinical environment during their practicum, while the control group will watch educational videos and participate in a general discussion group focused on auditory hallucinations.
Data will be collected using Google Forms at two time points: baseline and post-intervention. The research instruments include:
- A self-assessment questionnaire on confidence in auditory hallucination assessment and intervention;
- A scale measuring nursing students' knowledge, attitudes, and perceived empathy toward auditory hallucinations;
- The Auditory Hallucination Situational Involvement and Empathy Scale;
- An OSCE (Objective Structured Clinical Examination) evaluation form that assesses auditory hallucination assessment skills, empathy toward auditory hallucinations, communication skills, and the ability to manage auditory hallucinations." Data will be analyzed using IBM SPSS 24.0 for descriptive statistics and for comparing outcomes between the experimental group and the control group.
- Conditions
- Randomized Controlled Trial
- Being tested
- AR/VR technology-based training, traditional vedio and discussion group
- Keywords
- duditory hallucination assessment, nurse student, AR/VR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR/VR technology-based trainingBehavioural
Students will receive AR/VR Technology and OSCE in a Virtual Clinical Environment to learn how to assess and manage patients with auditory hallucination. The course was designed as a diverse and interactive learning experience, integrating a virtual clinical environment for auditory hallucinations with the application of Objective Structured Clinical Examination (OSCE). The practicum lasts approximately 15 days, with 8 hours per day. The teaching activities of the course will be held 5 times on days 4, 6, 8, 10, and 12 of the practicum. Additionally, students will have access to the AR/VR materials for self-practice during the practicum.
traditional vedio and discussion groupBehavioural
Students will receive a traditional course on auditory hallucination assessment, which includes watching educational videos and participating in a general discussion group on auditory hallucinations. The practicum lasts approximately 15 days, with 8 hours per day. The teaching activities of the traditional course will be held 5 times on days 4, 6, 8, 10, and 12 of the practicum.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group will receive AR/VR technology-based group training within a virtual clinical environment during their practicum Receives: Behavioral: AR/VR technology-based training |
| Control group | Active comparator | The control group will watch educational videos and participate in a general discussion group focused on auditory hallucinations. Receives: Behavioral: traditional vedio and discussion group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Auditory Hallucination Situational Involvement and Empathy
To assess the impact of the intervention on empathy, Schutte and Stilinović's (2017) method was used, employing the Situational Scale of Empathetic Responses (SSER) with 15 items. These are divided into two categories: ① Empathic Perspective Taking (7 items) and ② Empathic Concern (8 items). Participants imagined interacting with a person hearing voices and rated the items on a 5-point Likert scale, from \'strongly disagree\' (1) to \'strongly agree\' (5). Higher scores indicate greater empathy in auditory hallucination scenarios.
Measured: at baseline on day 2 or 3 of the 15-day practicum (T0) and on day 15 of the practicum, three days after the intervention has finished (T1)
OSCE Evaluation Form for Auditory Hallucination Assessment and Intervention
This form is part of the \"Application of AR/VR Technology and OSCE in a Virtual Clinical Environment\" teaching practice project. Both the experimental and control groups will watch videos; however, the control group will watch standard videos, while the experimental group will use AR/VR technology within a virtual clinical environment. Both groups will be assessed using OSCE combined with the virtual clinical environment.
The evaluation form, developed by the researcher, will undergo content validity review by experts once the videos are completed. Different versions of the virtual clinical environment and OSCE assessment will be used before and after the intervention. The study plans to develop four different versions, all of which will be reviewed by experts and piloted.
Measured: at baseline on day 2 or 3 of the 15-day practicum (T0) and on day 15 of the practicum, three days after the intervention has finished (T1)
Self-Assessment Questionnaire on Confidence in Auditory Hallucination Assessment and Intervention
This section consists of a self-designed questionnaire by the researcher, primarily aimed at measuring students\' confidence levels before and after the implementation of the teaching intervention. It includes 7 items and serves as a simple assessment tool.
Measured: at baseline on day 2 or 3 of the 15-day practicum (T0) and on day 15 of the practicum, three days after the intervention has finished (T1)
Nursing Students' Knowledge, Attitudes, and Perceived Empathy Toward Auditory Hallucinations
This assessment tool, developed by Mawson (2014), consists of 11 items related to statements about knowledge, attitudes, and empathy toward auditory hallucinations. Nursing students are asked to respond to these statements using a 5-point Likert scale, with responses ranging from \"strongly agree\" (5) to \"strongly disagree\" (1). These statements remain unchanged in the questionnaire.
Measured: at baseline on day 2 or 3 of the 15-day practicum (T0) and on day 15 of the practicum, three days after the intervention has finished (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start10 Sep 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Randomized Controlled TrialStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be divided into experimental and control groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiu Yueh Yang, PhD, Study chair, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605781
- Sponsor's protocol ID
- NYCU113035AEF
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Auditory Hallucination Assessment and Intervention Skills of Psychiatric Nursing Student Through AR/VR Technology and OSCE in Virtual Clinical Environments
- ClinicalTrials.gov ID
- NCT06605781
- Acronym / sponsor ID
- NYCU113035AEF
- Conditions
- Randomized Controlled Trial
- Keywords
- duditory hallucination assessment, nurse student, AR/VR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 20 Sep 2024 (actual)
- 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 purpose of this study is to develop and evaluate AI-based virtual reality teaching resources aimed at enhancing nursing students' competencies in assessing, communicating with, and managing patients experiencing auditory hallucinations. Specifically, this study seeks to improve the ability of nursing students to effectively assess auditory hallucinations, facilitate better communication with patients experiencing such disturbances, and strengthen their skills in managing these symptoms through the implementation of virtual reality-based educational scenarios.
Detailed description
This study employs a quasi-experimental design and uses a convenience sampling method to select senior students from a university nursing program as participants. The study aims to recruit 150 nursing students. The research involves two institutions, with participants being divided into groups within each institution. The students will be randomly assigned by computer into two groups: an experimental group and a control group. The experimental group will receive AR/VR technology-based group training within a virtual clinical environment during their practicum, while the control group will watch educational videos and participate in a general discussion group focused on auditory hallucinations.
Data will be collected using Google Forms at two time points: baseline and post-intervention. The research instruments include:
- A self-assessment questionnaire on confidence in auditory hallucination assessment and intervention;
- A scale measuring nursing students' knowledge, attitudes, and perceived empathy toward auditory hallucinations;
- The Auditory Hallucination Situational Involvement and Empathy Scale;
- An OSCE (Objective Structured Clinical Examination) evaluation form that assesses auditory hallucination assessment skills, empathy toward auditory hallucinations, communication skills, and the ability to manage auditory hallucinations." Data will be analyzed using IBM SPSS 24.0 for descriptive statistics and for comparing outcomes between the experimental group and the control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The participants will be divided into experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: AR/VR technology-based trainingThe experimental group will receive AR/VR technology-based group training within a virtual clinical environment during their practicum |
| Control group | Active comparator | Behavioral: traditional vedio and discussion groupThe control group will watch educational videos and participate in a general discussion group focused on auditory hallucinations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Nursing students who are about to undertake their psychiatry practicum.
- Those who are willing to join the study and sign the consent form.
- Those who are willing to bring a smartphone to connect with VR360 and watch the video.
- Those who are willing to use their smartphone for research purposes (a smartphone will be provided by the research team if needed).
Key exclusion criteria (1 listed)
- Individuals with hearing or vision impairments
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 |
|---|---|---|
| AR/VR technology-based trainingStudents will receive AR/VR Technology and OSCE in a Virtual Clinical Environment to learn how to assess and manage patients with auditory hallucination. The course was designed as a diverse and interactive learning experience, integrating a virtual clinical environment for auditory hallucinations with the application of Objective Structured Clinical Examination (OSCE). The practicum lasts approximately 15 days, with 8 hours per day. The teaching activities of the course will be held 5 times on days 4, 6, 8, 10, and 12 of the practicum. Additionally, students will have access to the AR/VR materials for self-practice during the practicum. | Behavioural | Experimental group |
| traditional vedio and discussion groupStudents will receive a traditional course on auditory hallucination assessment, which includes watching educational videos and participating in a general discussion group on auditory hallucinations. The practicum lasts approximately 15 days, with 8 hours per day. The teaching activities of the traditional course will be held 5 times on days 4, 6, 8, 10, and 12 of the practicum. | Behavioural | Control group |
Primary outcome
Auditory Hallucination Situational Involvement and Empathy
Time frame: at baseline on day 2 or 3 of the 15-day practicum (T0) and on day 15 of the practicum, three days after the intervention has finished (T1)
To assess the impact of the intervention on empathy, Schutte and Stilinović's (2017) method was used, employing the Situational Scale of Empathetic Responses (SSER) with 15 items. These are divided into two categories: ① Empathic Perspective Taking (7 items) and ② Empathic Concern (8 items). Participants imagined interacting with a person hearing voices and rated the items on a 5-point Likert scale, from \'strongly disagree\' (1) to \'strongly agree\' (5). Higher scores indicate greater empathy in auditory hallucination scenarios.
OSCE Evaluation Form for Auditory Hallucination Assessment and Intervention
Time frame: at baseline on day 2 or 3 of the 15-day practicum (T0) and on day 15 of the practicum, three days after the intervention has finished (T1)
This form is part of the \"Application of AR/VR Technology and OSCE in a Virtual Clinical Environment\" teaching practice project. Both the experimental and control groups will watch videos; however, the control group will watch standard videos, while the experimental group will use AR/VR technology within a virtual clinical environment. Both groups will be assessed using OSCE combined with the virtual clinical environment. The evaluation form, developed by the researcher, will undergo content validity review by experts once the videos are completed. Different versions of the virtual clinical environment and OSCE assessment will be used before and after the intervention. The study plans to develop four different versions, all of which will be reviewed by experts and piloted.
Self-Assessment Questionnaire on Confidence in Auditory Hallucination Assessment and Intervention
Time frame: at baseline on day 2 or 3 of the 15-day practicum (T0) and on day 15 of the practicum, three days after the intervention has finished (T1)
This section consists of a self-designed questionnaire by the researcher, primarily aimed at measuring students\' confidence levels before and after the implementation of the teaching intervention. It includes 7 items and serves as a simple assessment tool.
Nursing Students' Knowledge, Attitudes, and Perceived Empathy Toward Auditory Hallucinations
Time frame: at baseline on day 2 or 3 of the 15-day practicum (T0) and on day 15 of the practicum, three days after the intervention has finished (T1)
This assessment tool, developed by Mawson (2014), consists of 11 items related to statements about knowledge, attitudes, and empathy toward auditory hallucinations. Nursing students are asked to respond to these statements using a 5-point Likert scale, with responses ranging from \"strongly agree\" (5) to \"strongly disagree\" (1). These statements remain unchanged in the questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
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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.
Chiu Yueh Yang, PhD study chair
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AR/VR technology-based training and traditional vedio and discussion group in people with Randomized Controlled Trial, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 4 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 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Contact Chiu Yueh Yang, PhD (+8862-2826-7388, cyyang3@ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory Hallucination Situational Involvement and Empathy (time frame: at baseline on day 2 or 3 of the 15-day practicum (T0) and on day 15 of the practicum, three days after the intervention has finished (T1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2024.