Virtual RealityNCT05604924
Virtual Reality Training Simulator for Cesarean Section
A study testing virtual reality training for cesarean section in people with Virtual Reality, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The goal of this is to determine the effectiveness of virtual reality training simulator for cesarean section. Evaluate the effect of using VR surgery on the self-confidence and knowledge of cesarean section procedures. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- virtual reality training for cesarean section
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Sep 2022to 30 Nov 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residents and fellows receiving training at Seoul National University Bundang Hospital and who wish to participate in this study
Who cannot join
- If trainee refuse to participate in this study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeong-gi Do, 13620
About this study
Official title: A Clinical Trial to Evaluate Effectiveness of Virtual Reality Training Simulator for Cesarean Section
The goal of this is to determine the effectiveness of virtual reality training simulator for cesarean section.
Evaluate the effect of using VR surgery on the self-confidence and knowledge of cesarean section procedures.
Read the detailed description
A single center randomized controlled trial (RCT) was performed. The participants were obstetrics residents, fellows and residents in other majors with limited experience in performing cesarean section. The primary outcome measures were the self-assessment scores of trainee confidence using a virtual reality training and an objective assessment of the cognitive skills. The participants were randomly divided into a study group of VR training group and a control group. Participants in the study group used the VR application. The control group participants used similar content in a standard PowerPoint presentation on a laptop.
- Conditions
- Virtual Reality
- Being tested
- virtual reality training for cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality training for cesarean sectionOther
Participants who received virtual reality training for cesarean section can learn the surgical procedures as if they were in a real field.
| Study group | Role | What they receive |
|---|---|---|
| Participants who received virtual reality training | Experimental | Not described Receives: Other: virtual reality training for cesarean section |
| Participants who received similar contents in a standard PowerPoint presentation on a laptop | Placebo comparator | Not described Receives: Other: virtual reality training for cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement on the knowledge of cesarean section procedures.
After using VR training, the test scores cesarean section procedures.
Measured: 1 month after examination
improvement on the self-confidence of cesarean section procedures.
After using VR training, the self-assessment scores of trainee confidence via questionnaire
Measured: 1 month after examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start10 Sep 2022
- Primary completion15 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jee Yoon Park, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604924
- Sponsor's protocol ID
- B-2205-759-303
- Status last verified
- Apr 2023
- First submitted
- 26 Oct 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate Effectiveness of Virtual Reality Training Simulator for Cesarean Section
- ClinicalTrials.gov ID
- NCT05604924
- Acronym / sponsor ID
- B-2205-759-303
- Conditions
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 3 Nov 2022 (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 goal of this is to determine the effectiveness of virtual reality training simulator for cesarean section.
Evaluate the effect of using VR surgery on the self-confidence and knowledge of cesarean section procedures.
Detailed description
A single center randomized controlled trial (RCT) was performed. The participants were obstetrics residents, fellows and residents in other majors with limited experience in performing cesarean section. The primary outcome measures were the self-assessment scores of trainee confidence using a virtual reality training and an objective assessment of the cognitive skills. The participants were randomly divided into a study group of VR training group and a control group. Participants in the study group used the VR application. The control group participants used similar content in a standard PowerPoint presentation on a laptop.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants who received virtual reality training | Experimental | Other: virtual reality training for cesarean section |
| Participants who received similar contents in a standard PowerPoint presentation on a laptop | Placebo comparator | Other: virtual reality training for cesarean section |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Residents and fellows receiving training at Seoul National University Bundang Hospital and who wish to participate in this study
Key exclusion criteria (1 listed)
- If trainee refuse to participate in this study
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 |
|---|---|---|
| virtual reality training for cesarean sectionParticipants who received virtual reality training for cesarean section can learn the surgical procedures as if they were in a real field. | Other | Participants who received similar contents in a standard PowerPoint presentation on a laptop, Participants who received virtual reality training |
Primary outcome
improvement on the knowledge of cesarean section procedures.
Time frame: 1 month after examination
After using VR training, the test scores cesarean section procedures.
improvement on the self-confidence of cesarean section procedures.
Time frame: 1 month after examination
After using VR training, the self-assessment scores of trainee confidence via questionnaire
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 13 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Virtual Reality
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Not yet recruitingObservational study
Validity, Reliability, and Clinical Correlates of Immersive Virtual Reality Adaptation of the Five Times Sit-to-stand Test and Timed up and go Tests in Women With Fibromyalgia Syndrome
Fibromyalgia Syndrome
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain, Anxiety
Recruiting
Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures
Anxiety
Not yet recruiting
Virtual Reality Intervention to Improve Comfort in Hospitalized Hematology Patients
Hematologic Cancer
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 virtual reality training for cesarean section in people with Virtual Reality, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 13 Apr 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
improvement on the knowledge of cesarean section procedures. (time frame: 1 month after examination). The study lists 2 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 13 Apr 2023.