ProcedureIVR-PNCT06396572
Immersive Virtual Reality (IVR) Procedure
A study testing IVR-Procedure and Nursing Clinical Laboratory practice in people with Procedure, run by National University of Singapore at 1 site in Singapore.
Trial summary
A pilot randomised controlled trial to assess the nursing students' learning outcomes of the urinary catheterisation procedure by comparing the immersive virtual reality (IVR) to traditional lab sessions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Procedure
- What is being tested?
- IVR-Procedure and Nursing Clinical Laboratory practice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteSingapore
- Study dates
- 17 Jan 2023to 27 Mar 2023
- 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
- Year 2 Nursing students enrolled in the PPNP2 module
Who cannot join
- Students who declined to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Clinical Procedures Through Deliberate Practice Using Immersive Virtual Reality
A pilot randomised controlled trial to assess the nursing students' learning outcomes of the urinary catheterisation procedure by comparing the immersive virtual reality (IVR) to traditional lab sessions.
Read the detailed description
Design: A pilot randomised controlled trial was employed to assess the learning outcomes of the urinary catheterisation procedure by comparing the immersive virtual reality (IVR) intervention to traditional lab sessions.
Eligibility: Second-year undergraduate nursing students (n = 200) enrolled into the module NUR2125 (Pathophysiology, Pharmacology and Nursing Practice II) were invited to participate in the study.
Setting: The study was conducted at a university in Singapore from January to April 2023.
Procedure: Ten lab groups of second-year undergraduate nursing students were invited to participate in the study. They received the standard blended learning activities, which included clinical lab sessions and videos on the urinary catheterisation procedure. Out of the ten groups, four groups were randomly allocated to the IVR intervention group, and another four groups were randomly assigned to the waitlist control group (traditional lab sessions).
- For the intervention group (IVR), the students used the IVR device for practice in class under the supervision of their tutor. They then loaned the IVR device for two weeks for home practice.
- For the waitlist control group (traditional lab sessions), they learned and practiced the urinary catheterisation procedure in class. Students received the additional intervention (using the IVR device for home practice) after the collection of post-test data.
Data collection: Prior to lab practice, each participant completed a demographic survey and a set of pre-test questionnaires on personality inventory, cognitive load, and representation of VR in education. Only students who voluntarily joined the programme were recruited into the study.
The participants completed the post-test questionnaires in March 2023 prior to their formative clinical assessment.
- Conditions
- Procedure
- Being tested
- IVR-Procedure, Nursing Clinical Laboratory practice
- Keywords
- urinary catheterisation, Immersive Virtual Reality, Clinical competency, Clinical procedures, Nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVR-ProcedureProcedure or surgery
Using immersive virtual reality to learn urinary catheterisation procedure
Nursing Clinical Laboratory practiceProcedure or surgery
Also called Active Comparator
Using nursing clinical laboratory sessions to learn urinary catheterisation procedure
| Study group | Role | What they receive |
|---|---|---|
| Immersive Virtual Reality | Experimental | The Participants used Immersive Virtual Reality for learning and practice urinary catheterisation procedure Receives: Procedure: IVR-Procedure |
| Nursing clinical laboratory | Active comparator | The Participants used a traditional nursing clinical laboratory for face to face learning and practice urinary catheterisation procedure Receives: Procedure: Nursing Clinical Laboratory practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Load
The Cognitive Load Scale (CLS) was adapted from Leppink et al. (2013) and analyses the level of working memory resources needed to process information. It consists of 10 items that are rated on an 11-point scale (0 = Not at all the case to 10 = Completely the case). Items 1 to 3 relate to intrinsic load, items 4 to 6 fall under extraneous load, and items 7 to 10 are associated with germane load. Responses are added to give a total score for each subscale, which ranges from 0 (lowest) to 30 or 40 (highest) in the case of the germane load subscale. Higher total scores indicate more working memory resources required to process the information load under different conditions.
Measured: 3 months
Secondary outcomes (1)
Clinical skill competency
To evaluate the skills competency, the nursing students were assessed by their tutors using a competency assessment tool based on the skills checklist. Within the checklist, it determined the performance of the participants on completing the procedural steps on a 10-point scale (0-3 = Need improvement, 4-6 = Meet expectation, 7-9 = Exceed expectation), which was computed into a percentage score. Higher scores indicate a higher competency level in conducting the urinary catheterization procedure.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start17 Jan 2023
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProcedureStudies of the same condition, open and under way.
- 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
- Cluster randomization trial
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Singapore
- Responsible party
- Principal investigator, Lau Siew Tiang, National University of Singapore
- Investigators
- Siew Tiang LAU, PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396572
- Sponsor's protocol ID
- IVR-Procedure
- Acronym
- IVR-P
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Clinical Procedures Through Deliberate Practice Using Immersive Virtual Reality
- ClinicalTrials.gov ID
- NCT06396572
- Acronym / sponsor ID
- IVR-P / IVR-Procedure
- Conditions
- Procedure
- Keywords
- urinary catheterisation, Immersive Virtual Reality, Clinical competency, Clinical procedures, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Ministry of Education, Singapore
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 2 May 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.
A pilot randomised controlled trial to assess the nursing students' learning outcomes of the urinary catheterisation procedure by comparing the immersive virtual reality (IVR) to traditional lab sessions.
Detailed description
Design: A pilot randomised controlled trial was employed to assess the learning outcomes of the urinary catheterisation procedure by comparing the immersive virtual reality (IVR) intervention to traditional lab sessions.
Eligibility: Second-year undergraduate nursing students (n = 200) enrolled into the module NUR2125 (Pathophysiology, Pharmacology and Nursing Practice II) were invited to participate in the study.
Setting: The study was conducted at a university in Singapore from January to April 2023.
Procedure: Ten lab groups of second-year undergraduate nursing students were invited to participate in the study. They received the standard blended learning activities, which included clinical lab sessions and videos on the urinary catheterisation procedure. Out of the ten groups, four groups were randomly allocated to the IVR intervention group, and another four groups were randomly assigned to the waitlist control group (traditional lab sessions).
- For the intervention group (IVR), the students used the IVR device for practice in class under the supervision of their tutor. They then loaned the IVR device for two weeks for home practice.
- For the waitlist control group (traditional lab sessions), they learned and practiced the urinary catheterisation procedure in class. Students received the additional intervention (using the IVR device for home practice) after the collection of post-test data.
Data collection: Prior to lab practice, each participant completed a demographic survey and a set of pre-test questionnaires on personality inventory, cognitive load, and representation of VR in education. Only students who voluntarily joined the programme were recruited into the study.
The participants completed the post-test questionnaires in March 2023 prior to their formative clinical assessment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomization trial
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality | Experimental | Procedure: IVR-ProcedureThe Participants used Immersive Virtual Reality for learning and practice urinary catheterisation procedure |
| Nursing clinical laboratory | Active comparator | Procedure: Nursing Clinical Laboratory practiceThe Participants used a traditional nursing clinical laboratory for face to face learning and practice urinary catheterisation procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Year 2 Nursing students enrolled in the PPNP2 module
Key exclusion criteria (1 listed)
- Students who declined to participate
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 |
|---|---|---|
| IVR-ProcedureUsing immersive virtual reality to learn urinary catheterisation procedure | Procedure or surgery | Immersive Virtual Reality |
| Nursing Clinical Laboratory practiceAlso: Active ComparatorUsing nursing clinical laboratory sessions to learn urinary catheterisation procedure | Procedure or surgery | Nursing clinical laboratory |
Primary outcome
Cognitive Load
Time frame: 3 months
The Cognitive Load Scale (CLS) was adapted from Leppink et al. (2013) and analyses the level of working memory resources needed to process information. It consists of 10 items that are rated on an 11-point scale (0 = Not at all the case to 10 = Completely the case). Items 1 to 3 relate to intrinsic load, items 4 to 6 fall under extraneous load, and items 7 to 10 are associated with germane load. Responses are added to give a total score for each subscale, which ranges from 0 (lowest) to 30 or 40 (highest) in the case of the germane load subscale. Higher total scores indicate more working memory resources required to process the information load under different conditions.
1 secondary outcome
Clinical skill competency
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 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.
Siew Tiang LAU, PhD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVR-Procedure and Nursing Clinical Laboratory practice in people with Procedure, run by National University of Singapore at 1 site in Singapore.
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 1 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: finished, as of the sponsor's last update on 2 May 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 Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Load (time frame: 3 months). 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 2 May 2024.