Blood Transfusion ComplicationNCT05922163
Blood Transfusion Education Using Blended Virtual Reality and Simulation for Nursing Undergraduate Students
A study testing Evidence-based VR simulation in people with Blood Transfusion Complication, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Nurse-administered blood transfusion (BT) is a common form of medical treatment, but nursing students are often excluded from participating in and observing BTs during clinical placements. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blood Transfusion Complication
- What is being tested?
- Evidence-based VR simulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2022to 30 Jun 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All undergraduate nursing students enrolled in the 'Nursing of Adults' course in a pre-licensure program at a Hong Kong university.
Who cannot join
- Students who had vision impairment to watch VR videos;
- Students who had neck pain/ injury to move their head, or open wound to wear the VR headset;
- Students who experienced nausea and dizziness when watching VR videos;
- Students who had epileptic symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Transfusion Education Using Blended Virtual Reality and Simulation for Nursing Undergraduate Students: a Randomized Controlled Trial
Nurse-administered blood transfusion (BT) is a common form of medical treatment, but nursing students are often excluded from participating in and observing BTs during clinical placements. To address clinical placement limitations, nursing educators have increasingly adopted technology-guided simulation pedagogies, including virtual reality (VR) simulation, for nursing students' clinical skills education.
- Conditions
- Blood Transfusion Complication
- Being tested
- Evidence-based VR simulation
- Keywords
- Blood transfusion, Nursing education, Nursing practice, Simulation, Virtual reality
- Medical subject headings
- Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-based VR simulationDevice
Evidence-based VR simulation videos on BTs for nursing students were developed, including 1) animated blood formation physiology and side effects of BT and 2) 360° BT nursing practice.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Receive the usual blood transfusion education (i.e. Zoom lecture) with the developed VR (Virtual Reality) video education. Receives: Device: Evidence-based VR simulation |
| Control Group | No intervention | Receive the usual blood transfusion education (i.e. Zoom lecture) only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood transfusion knowledge scale (optimised version of the routine blood transfusion knowledge questionnaire [RBTKQ-O])
A 34-item scale with score ranging from 0 to 34, higher scores indicate higher levels of blood transfusion knowledge.
Measured: 12-week
Secondary outcomes (2)
Student satisfaction and self-confidence scale [SSSC]
A 13-item scale with score ranging from 13 to 65, higher scores in both subscales refer to higher satisfaction levels with the intervention and self-confidence in conducting blood transfusion practice, respectively.
Measured: 12-week
General self-efficacy scale [GSES]
A 10-item scale with score ranging from 10 to 40, higher scores indicate higher levels of self-efficacy regarding blood transfusion practice.
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Mar 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Transfusion ComplicationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922163
- Sponsor's protocol ID
- VR2022
- Status last verified
- Jun 2023
- First submitted
- 18 Jun 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Transfusion Education Using Blended Virtual Reality and Simulation for Nursing Undergraduate Students: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05922163
- Acronym / sponsor ID
- VR2022
- Conditions
- Blood Transfusion Complication
- Keywords
- Blood transfusion, Nursing education, Nursing practice, Simulation, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 28 Jun 2023 (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.
Nurse-administered blood transfusion (BT) is a common form of medical treatment, but nursing students are often excluded from participating in and observing BTs during clinical placements. To address clinical placement limitations, nursing educators have increasingly adopted technology-guided simulation pedagogies, including virtual reality (VR) simulation, for nursing students' clinical skills education.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Evidence-based VR simulationReceive the usual blood transfusion education (i.e. Zoom lecture) with the developed VR (Virtual Reality) video education. |
| Control Group | No intervention | –Receive the usual blood transfusion education (i.e. Zoom lecture) only. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All undergraduate nursing students enrolled in the 'Nursing of Adults' course in a pre-licensure program at a Hong Kong university.
Key exclusion criteria (4 listed)
- Students who had vision impairment to watch VR videos;
- Students who had neck pain/ injury to move their head, or open wound to wear the VR headset;
- Students who experienced nausea and dizziness when watching VR videos;
- Students who had epileptic symptoms
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 |
|---|---|---|
| Evidence-based VR simulationEvidence-based VR simulation videos on BTs for nursing students were developed, including 1) animated blood formation physiology and side effects of BT and 2) 360° BT nursing practice. | Device | Intervention Group |
Primary outcome
Blood transfusion knowledge scale (optimised version of the routine blood transfusion knowledge questionnaire [RBTKQ-O])
Time frame: 12-week
A 34-item scale with score ranging from 0 to 34, higher scores indicate higher levels of blood transfusion knowledge.
2 secondary outcomes
Student satisfaction and self-confidence scale [SSSC]
Time frame: 12-week
General self-efficacy scale [GSES]
Time frame: 12-week
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 28 Jun 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-based VR simulation in people with Blood Transfusion Complication, run by The University of Hong Kong at 1 site in Hong Kong.
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 4 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 28 Jun 2023. 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 Hong Kong. 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?
Blood transfusion knowledge scale (optimised version of the routine blood transfusion knowledge questionnaire [RBTKQ-O]) (time frame: 12-week). 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 28 Jun 2023.