Clinical Skills TrainingNCT07260929
VR Goggles-Supported Virtual Reality Model in Midwifery Basic Clinical Skills Training
A study testing VR Goggle-Assisted Simulation Training and Standard Clinical Skills Training in people with Clinical Skills Training and Midwifery Education, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated the effects of virtual reality (VR)-supported training compared with low-fidelity simulation on learning satisfaction, self-confidence in learning, and perceived stress among undergraduate midwifery students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Skills Training, Midwifery Education
- What is being tested?
- VR Goggle-Assisted Simulation Training and Standard Clinical Skills Training
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 Apr 2026
- 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
- Currently enrolled as an undergraduate midwifery student at Gaziantep University.
- Registered in or scheduled to take the "Basic Clinical Skills" course during the study period.
- Aged 18 years or older.
- Able to provide informed consent and willing to participate throughout the study.
- Has no previous formal training with virtual reality (VR) simulation related to midwifery clinical skills.
- Able to use VR goggles safely (no known conditions that prevent VR use, such as severe motion sickness).
Who cannot join
- A diagnosed visual, neurological, or vestibular disorder that may interfere with VR use (e.g., epilepsy, severe vertigo).
- A history of severe motion sickness symptoms triggered by digital screens or VR environments.
- Participated previously in a pilot version of the VR training module.
- Currently taking a leave of absence or not actively attending coursework.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University
Gaziantep, Gaziantep, 27310
About this study
Official title: VR Goggles-Supported Virtual Reality Model in Midwifery Basic Clinical Skills Training: A Randomized Controlled Trial
This randomized controlled trial evaluated the effects of virtual reality (VR)-supported training compared with low-fidelity simulation on learning satisfaction, self-confidence in learning, and perceived stress among undergraduate midwifery students.
A total of 128 second-year midwifery students were randomly assigned to either a VR-supported training group (n = 64) or a low-fidelity simulation group (n = 64). Both groups participated in a structured four-week training program covering five fundamental clinical skills: patient positioning, basic bedside care, vital signs assessment, intramuscular injection, and intravenous injection. Participants attended one supervised 45-60-minute training session per week. The VR group received training using Meta Quest 3 head-mounted displays, whereas the control group received conventional low-fidelity simulation training using manikins and clinical skills laboratory equipment.
Read more
Learning satisfaction and self-confidence were assessed using the Student Satisfaction and Self-Confidence in Learning Scale, while perceived stress was measured using a single-item numerical rating scale ranging from 0 to 10. Outcomes were assessed immediately after completion of the training program.
The study aimed to compare the two educational approaches in terms of students' learning satisfaction, self-confidence, and perceived stress. The findings may contribute to the evidence regarding the potential role of VR-supported simulation in undergraduate midwifery education.
- Conditions
- Clinical Skills Training, Midwifery Education
- Being tested
- VR Goggle-Assisted Simulation Training, Standard Clinical Skills Training
- Keywords
- Midwifery education, clinical skills training, virtual reality-based learning, simulation-based training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Goggle-Assisted Simulation TrainingBehavioural
The intervention consisted of a structured four-week virtual reality (VR)-supported clinical skills training program using Meta Quest 3 head-mounted displays. Participants attended one supervised 45-60-minute session per week. Training covered patient positioning, basic bedside care, vital signs assessment, intramuscular injection, and intravenous injection. Each session included instructor demonstration, individual practice, and structured debriefing with feedback. Students practiced clinical skills in an immersive virtual environment under one-to-one instructor supervision.
Standard Clinical Skills TrainingBehavioural
Participants in the control group received a structured four-week clinical skills training program using low-fidelity simulation equipment, including manikins, injection training models, and standard clinical laboratory materials. Training covered the same five clinical skills as the VR group, with one supervised 45-60-minute session per week. Both groups received identical learning objectives, educational content, training duration, instructor guidance, and structured debriefing with feedback.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (VR Goggle-Assisted VR Training) | Experimental | Participants in this arm will receive basic clinical skills training using a VR goggle-supported virtual reality model specifically designed for midwifery education. The VR module includes interactive simulations, step-by-step procedural guidance, and scenario-based skill practice. Training will be delivered individually under supervision and will cover essential midwifery clinical skills. Receives: Behavioral: VR Goggle-Assisted Simulation Training |
| Active Comparator: Traditional Training | Active comparator | Participants in this arm will receive traditional basic clinical skills training using standard educational methods such as demonstration, skills laboratory practice, and return demonstration. This training follows the current curriculum used in midwifery clinical skills education and does not include virtual reality components. Receives: Behavioral: Standard Clinical Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Student Satisfaction and Self-Confidence in Learning
Student satisfaction and self-confidence in learning were assessed using the validated Student Satisfaction and Self-Confidence in Learning Scale. The instrument consists of 13 items rated on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). It comprises two subscales: satisfaction with learning (5 items) and self-confidence in learning (8 items). Total scores range from 13 to 65, with higher scores indicating greater learning satisfaction and self-confidence. The scale was administered immediately after completion of the four-week training program. Outcomes were compared between the virtual reality-supported training group and the low-fidelity simulation group.
Measured: Immediately after completion of the four-week training program (post-training assessment).
Secondary outcomes (1)
Perceived Stress During Clinical Skills Training
Perceived stress during clinical skills training was assessed using a single-item, 11-point numerical rating scale ranging from 0 (no stress) to 10 (highest perceived stress). Higher scores indicate greater perceived stress. Stress scores were compared between the virtual reality-supported training group and the low-fidelity simulation group.
Measured: Immediately after completion of the four-week training program (post-training assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Dec 2025
- Primary completion1 Mar 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Skills TrainingStudies 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Dirgar, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260929
- Sponsor's protocol ID
- 2025/317
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR Goggles-Supported Virtual Reality Model in Midwifery Basic Clinical Skills Training: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07260929
- Acronym / sponsor ID
- 2025/317
- Conditions
- Clinical Skills Training, Midwifery Education
- Keywords
- Midwifery education, clinical skills training, virtual reality-based learning, simulation-based training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 3 Dec 2025 (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.
This randomized controlled trial evaluated the effects of virtual reality (VR)-supported training compared with low-fidelity simulation on learning satisfaction, self-confidence in learning, and perceived stress among undergraduate midwifery students.
A total of 128 second-year midwifery students were randomly assigned to either a VR-supported training group (n = 64) or a low-fidelity simulation group (n = 64). Both groups participated in a structured four-week training program covering five fundamental clinical skills: patient positioning, basic bedside care, vital signs assessment, intramuscular injection, and intravenous injection. Participants attended one supervised 45-60-minute training session per week. The VR group received training using Meta Quest 3 head-mounted displays, whereas the control group received conventional low-fidelity simulation training using manikins and clinical skills laboratory equipment.
Learning satisfaction and self-confidence were assessed using the Student Satisfaction and Self-Confidence in Learning Scale, while perceived stress was measured using a single-item numerical rating scale ranging from 0 to 10. Outcomes were assessed immediately after completion of the training program.
The study aimed to compare the two educational approaches in terms of students' learning satisfaction, self-confidence, and perceived stress. The findings may contribute to the evidence regarding the potential role of VR-supported simulation in undergraduate midwifery education.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (VR Goggle-Assisted VR Training) | Experimental | Behavioral: VR Goggle-Assisted Simulation TrainingParticipants in this arm will receive basic clinical skills training using a VR goggle-supported virtual reality model specifically designed for midwifery education. The VR module includes interactive simulations, step-by-step procedural guidance, and scenario-based skill practice. Training will be delivered individually under supervision and will cover essential midwifery clinical skills. |
| Active Comparator: Traditional Training | Active comparator | Behavioral: Standard Clinical Skills TrainingParticipants in this arm will receive traditional basic clinical skills training using standard educational methods such as demonstration, skills laboratory practice, and return demonstration. This training follows the current curriculum used in midwifery clinical skills education and does not include virtual reality components. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Currently enrolled as an undergraduate midwifery student at Gaziantep University.
- Registered in or scheduled to take the "Basic Clinical Skills" course during the study period.
- Aged 18 years or older.
- Able to provide informed consent and willing to participate throughout the study.
- Has no previous formal training with virtual reality (VR) simulation related to midwifery clinical skills.
Key exclusion criteria (4 listed)
- A diagnosed visual, neurological, or vestibular disorder that may interfere with VR use (e.g., epilepsy, severe vertigo).
- A history of severe motion sickness symptoms triggered by digital screens or VR environments.
- Participated previously in a pilot version of the VR training module.
- Currently taking a leave of absence or not actively attending coursework.
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 |
|---|---|---|
| VR Goggle-Assisted Simulation TrainingThe intervention consisted of a structured four-week virtual reality (VR)-supported clinical skills training program using Meta Quest 3 head-mounted displays. Participants attended one supervised 45-60-minute session per week. Training covered patient positioning, basic bedside care, vital signs assessment, intramuscular injection, and intravenous injection. Each session included instructor demonstration, individual practice, and structured debriefing with feedback. Students practiced clinical skills in an immersive virtual environment under one-to-one instructor supervision. | Behavioural | Experimental (VR Goggle-Assisted VR Training) |
| Standard Clinical Skills TrainingParticipants in the control group received a structured four-week clinical skills training program using low-fidelity simulation equipment, including manikins, injection training models, and standard clinical laboratory materials. Training covered the same five clinical skills as the VR group, with one supervised 45-60-minute session per week. Both groups received identical learning objectives, educational content, training duration, instructor guidance, and structured debriefing with feedback. | Behavioural | Active Comparator: Traditional Training |
Primary outcome
Student Satisfaction and Self-Confidence in Learning
Time frame: Immediately after completion of the four-week training program (post-training assessment).
Student satisfaction and self-confidence in learning were assessed using the validated Student Satisfaction and Self-Confidence in Learning Scale. The instrument consists of 13 items rated on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). It comprises two subscales: satisfaction with learning (5 items) and self-confidence in learning (8 items). Total scores range from 13 to 65, with higher scores indicating greater learning satisfaction and self-confidence. The scale was administered immediately after completion of the four-week training program. Outcomes were compared between the virtual reality-supported training group and the low-fidelity simulation group.
1 secondary outcome
Perceived Stress During Clinical Skills Training
Time frame: Immediately after completion of the four-week training program (post-training assessment).
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 14 Oct 2026.
- 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 VR Goggle-Assisted Simulation Training and Standard Clinical Skills Training in people with Clinical Skills Training and Midwifery Education, run by University of Gaziantep at 1 site in Turkey (Türkiye).
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 6 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 14 Oct 2026. 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 Turkey (Türkiye). 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?
Student Satisfaction and Self-Confidence in Learning (time frame: Immediately after completion of the four-week training program (post-training assessment).). 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 14 Oct 2026.