Nursing EducationHMD VRNCT07899008
Effects of HMD-Based Virtual Reality Simulation on Enema Administration Skills in Nursing Students
A study testing HMD-Based Immersive Virtual Reality Simulation in people with Nursing Education, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aimed to evaluate the effects of head-mounted display (HMD)-based immersive virtual reality (VR) simulation on enema administration skills, learning satisfaction, and self-confidence among nursing students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing Education
- What is being tested?
- HMD-Based Immersive Virtual Reality Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Apr 2026to 29 May 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
- Being a first-year undergraduate nursing student enrolled in the Fundamentals of Nursing course for the first time.
- Voluntarily agreeing to participate in the study.
- Providing written informed consent.
Who cannot join
- Having graduated from a healthcare vocational high school.
- Having previously graduated from an associate degree or undergraduate program in a health-related field.
- Having received previous theoretical or practical training in enema administration.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun University Faculty of Health Sciences, Department of Fundamental of Nursing, Giresun, Turkey.
Giresun, Piraziz, 28340
About this study
Official title: Effects of Head-Mounted Display-Based Immersive Virtual Reality Simulation on Enema Administration Skills, Learning Satisfaction, and Self-Confidence Among Nursing Students: A Randomized Controlled Trial
This randomized controlled trial aimed to evaluate the effects of head-mounted display (HMD)-based immersive virtual reality (VR) simulation on enema administration skills, learning satisfaction, and self-confidence among nursing students.
The study was conducted with 68 first-year nursing students at a public university in Türkiye during the spring semester of the 2025-2026 academic year. Participants were randomly assigned to an intervention group (n=34) or a control group (n=34).
Read more
Both groups received standardized theoretical and practical training in enema administration, including a video demonstration and hands-on practice using a low-fidelity patient mannequin. In addition to standard training, the intervention group participated in a single 10-15-minute HMD-based immersive VR simulation session. The control group received standard training only during the study period.
Enema administration skills were assessed using a 30-item skills checklist, while learning satisfaction and self-confidence were evaluated using the Student Satisfaction and Self-Confidence in Learning Scale. Assessments were conducted at the initial measurement and at one-month follow-up.
The study aimed to determine whether incorporating HMD-based VR simulation into conventional nursing skills education improves students' clinical skill performance, learning satisfaction, and self-confidence.
Read the detailed description
Study Design and Setting
This study was designed as a two-arm, parallel-group randomized controlled trial to evaluate the effects of head-mounted display (HMD)-based immersive virtual reality (VR) simulation on enema administration skills, learning satisfaction, and self-confidence among undergraduate nursing students. The study was conducted at the Nursing Department of a public university in Türkiye during the spring semester of the 2025-2026 academic year.
Participants and Sample Size
The study population consisted of first-year nursing students enrolled in the Fundamentals of Nursing course. The required sample size was calculated using G*Power 3.1.9, with a significance level of 0.05, an effect size of 0.75, and a statistical power of 90%. The minimum required sample size was 62 participants. Considering potential attrition, the sample size was increased by approximately 10%, resulting in 68 participants.
Students were eligible if they were taking the Fundamentals of Nursing course for the first time and voluntarily agreed to participate. Students who had graduated from a health-related vocational high school or an associate or undergraduate health sciences program, or who had previously received training in enema administration, were excluded.
Randomization and Masking
A total of 68 eligible nursing students were randomly assigned to the intervention group (n=34) or control group (n=34) using a card-drawing method. Due to the nature of the educational interventions, participants, instructors, and the outcome assessor were not blinded to group allocation. For statistical analysis, the groups were coded as A and B.
Educational Interventions
All participants received standardized theoretical and practical training in cleansing enema administration. The theoretical session lasted approximately 30-40 minutes and included a PowerPoint presentation, questions and answers, and discussion of indications, procedural steps, and safety considerations. Participants subsequently watched a three-minute instructional video and observed an instructor-led demonstration using a low-fidelity patient mannequin.
Following the demonstration, all participants individually performed the enema administration procedure on the mannequin. Their performance was evaluated using a standardized skills checklist before the VR intervention.
In addition to standard training, participants in the intervention group completed one HMD-based immersive VR simulation session lasting approximately 10-15 minutes under the guidance of a researcher with expertise in information technology. The simulation provided an interactive virtual environment for practicing and reinforcing the procedural steps of enema administration.
Participants in the control group received standard theoretical and mannequin-based practical training without additional VR simulation during the study period.
Outcome Assessment and Follow-Up
The primary outcome was enema administration skill performance, assessed using a 30-item skills checklist developed from established nursing procedure references. Each item was scored as performed (2 points), partially performed (1 point), or not performed (0 points), yielding a total score ranging from 0 to 60. Higher scores indicated better skill performance.
Secondary outcomes included learning satisfaction and self-confidence, assessed using the Student Satisfaction and Self-Confidence in Learning Scale. The 12-item scale consists of two subscales: learning satisfaction (5 items) and self-confidence (7 items), rated on a five-point Likert scale.
Skill performance was initially assessed after standard training and before the VR intervention. Learning satisfaction and self-confidence were first assessed after completion of the assigned educational interventions.
One month after the educational interventions, participants in both groups performed the enema administration procedure again on a low-fidelity patient mannequin. Skill performance, learning satisfaction, and self-confidence were reassessed using the same instruments.
After all follow-up assessments and data collection procedures had been completed, participants in the control group were also offered the opportunity to experience the HMD-based VR simulation to ensure educational equity. This delayed VR training was not included in the comparative outcome analyses.
Statistical Analysis
Data were analyzed using IBM SPSS Statistics version 25.0. Descriptive statistics were used to summarize participant characteristics and outcome measures. Distributional assumptions were assessed using the Shapiro-Wilk test and graphical methods. Depending on the characteristics of the data, chi-square tests, Fisher's exact tests, Mann-Whitney U tests, and paired-samples t-tests were used.
Analysis of covariance (ANCOVA) was performed to compare follow-up skill performance between the groups while adjusting for initial skill scores. Statistical significance was set at p<0.05.
Ethical Considerations
The study was approved by the Giresun University Medical Research Ethics Committee (April 15, 2026; Approval No. 04). Institutional permission was obtained, and written informed consent was provided by all participants before enrollment. The study was conducted in accordance with the principles of the Declaration of Helsinki.
- Conditions
- Nursing Education
- Being tested
- HMD-Based Immersive Virtual Reality Simulation
- Keywords
- Nursing Education, Enema Administration, Head-Mounted Display, Virtual Reality Simulation, Clinical Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMD-Based Immersive Virtual Reality SimulationOther
Participants in the experimental group received an additional 10-15-minute immersive virtual reality training session using a head-mounted display (HMD). The interactive simulation enabled nursing students to practice enema administration procedures in a virtual clinical environment. This intervention was delivered following standardized theoretical and mannequin-based practical training.
| Study group | Role | What they receive |
|---|---|---|
| HMD-Based Virtual Reality Simulation | Experimental | Participants in the experimental group received standardized theoretical and practical training in enema administration, followed by an additional 10-15-minute HMD-based immersive virtual reality simulation session. The simulation provided an interactive environment for practicing and reinforcing enema administration skills. Receives: Other: HMD-Based Immersive Virtual Reality Simulation |
| Conventional Mannequin-Based Training | Active comparator | Participants in the control group received standardized theoretical education, instructional video demonstration, and practical training using a low-fidelity patient mannequin. No HMD-based virtual reality simulation was provided during the study period. Receives: Other: HMD-Based Immersive Virtual Reality Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enema Administration Skill Performance
Enema administration skill performance was assessed using a 30-item Enema Administration Skills Checklist. Each item was scored as performed (2 points), partially performed (1 point), or not performed (0 points). Total scores ranged from 0 to 60, with higher scores indicating better skill performance.
Measured: After standard training (before VR intervention) and at one-month follow-up
Secondary outcomes (2)
Student Satisfaction with Learning
Student satisfaction with learning was assessed using the five-item Satisfaction subscale of the Student Satisfaction and Self-Confidence in Learning Scale. Each item was rated on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores ranged from 5 to 25, with higher scores indicating greater satisfaction with the learning experience.
Measured: Immediately after the educational intervention and at one-month follow-up
Student Self-Confidence in Learning
Student self-confidence in learning was assessed using the seven-item Self-Confidence in Learning subscale of the Student Satisfaction and Self-Confidence in Learning Scale. Each item was rated on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores ranged from 7 to 35, with higher scores indicating greater self-confidence in learning.
Measured: Immediately after the educational intervention and at one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start24 Apr 2026
- Primary completion29 May 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing EducationStudies 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
- Model description
- This study used a two-arm, parallel-group randomized controlled design. A total of 68 nursing students were randomly assigned to either the intervention group (n=34) or the control group (n=34) using a card-drawing method. Both groups received standardized theoretical and mannequin-based practical training in enema administration. The intervention group additionally received HMD-based virtual reality simulation training, whereas the control group received standard training only. Outcomes were assessed at the initial measurement and at one-month follow-up.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AsumanCobanoglu, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899008
- Sponsor's protocol ID
- GUSBF-ENEMA-VR-2026-01
- Acronym
- HMD VR
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers. The study data will be maintained confidentially by the research team in accordance with institutional ethical requirements and participant confidentiality principles.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Head-Mounted Display-Based Immersive Virtual Reality Simulation on Enema Administration Skills, Learning Satisfaction, and Self-Confidence Among Nursing Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07899008
- Acronym / sponsor ID
- HMD VR / GUSBF-ENEMA-VR-2026-01
- Conditions
- Nursing Education
- Keywords
- Nursing Education, Enema Administration, Head-Mounted Display, Virtual Reality Simulation, Clinical Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 27 Oct 2026 (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 aimed to evaluate the effects of head-mounted display (HMD)-based immersive virtual reality (VR) simulation on enema administration skills, learning satisfaction, and self-confidence among nursing students.
The study was conducted with 68 first-year nursing students at a public university in Türkiye during the spring semester of the 2025-2026 academic year. Participants were randomly assigned to an intervention group (n=34) or a control group (n=34).
Both groups received standardized theoretical and practical training in enema administration, including a video demonstration and hands-on practice using a low-fidelity patient mannequin. In addition to standard training, the intervention group participated in a single 10-15-minute HMD-based immersive VR simulation session. The control group received standard training only during the study period.
Enema administration skills were assessed using a 30-item skills checklist, while learning satisfaction and self-confidence were evaluated using the Student Satisfaction and Self-Confidence in Learning Scale. Assessments were conducted at the initial measurement and at one-month follow-up.
The study aimed to determine whether incorporating HMD-based VR simulation into conventional nursing skills education improves students' clinical skill performance, learning satisfaction, and self-confidence.
Detailed description
Study Design and Setting
This study was designed as a two-arm, parallel-group randomized controlled trial to evaluate the effects of head-mounted display (HMD)-based immersive virtual reality (VR) simulation on enema administration skills, learning satisfaction, and self-confidence among undergraduate nursing students. The study was conducted at the Nursing Department of a public university in Türkiye during the spring semester of the 2025-2026 academic year.
Participants and Sample Size
The study population consisted of first-year nursing students enrolled in the Fundamentals of Nursing course. The required sample size was calculated using G*Power 3.1.9, with a significance level of 0.05, an effect size of 0.75, and a statistical power of 90%. The minimum required sample size was 62 participants. Considering potential attrition, the sample size was increased by approximately 10%, resulting in 68 participants.
Students were eligible if they were taking the Fundamentals of Nursing course for the first time and voluntarily agreed to participate. Students who had graduated from a health-related vocational high school or an associate or undergraduate health sciences program, or who had previously received training in enema administration, were excluded.
Randomization and Masking
A total of 68 eligible nursing students were randomly assigned to the intervention group (n=34) or control group (n=34) using a card-drawing method. Due to the nature of the educational interventions, participants, instructors, and the outcome assessor were not blinded to group allocation. For statistical analysis, the groups were coded as A and B.
Educational Interventions
All participants received standardized theoretical and practical training in cleansing enema administration. The theoretical session lasted approximately 30-40 minutes and included a PowerPoint presentation, questions and answers, and discussion of indications, procedural steps, and safety considerations. Participants subsequently watched a three-minute instructional video and observed an instructor-led demonstration using a low-fidelity patient mannequin.
Following the demonstration, all participants individually performed the enema administration procedure on the mannequin. Their performance was evaluated using a standardized skills checklist before the VR intervention.
In addition to standard training, participants in the intervention group completed one HMD-based immersive VR simulation session lasting approximately 10-15 minutes under the guidance of a researcher with expertise in information technology. The simulation provided an interactive virtual environment for practicing and reinforcing the procedural steps of enema administration.
Participants in the control group received standard theoretical and mannequin-based practical training without additional VR simulation during the study period.
Outcome Assessment and Follow-Up
The primary outcome was enema administration skill performance, assessed using a 30-item skills checklist developed from established nursing procedure references. Each item was scored as performed (2 points), partially performed (1 point), or not performed (0 points), yielding a total score ranging from 0 to 60. Higher scores indicated better skill performance.
Secondary outcomes included learning satisfaction and self-confidence, assessed using the Student Satisfaction and Self-Confidence in Learning Scale. The 12-item scale consists of two subscales: learning satisfaction (5 items) and self-confidence (7 items), rated on a five-point Likert scale.
Skill performance was initially assessed after standard training and before the VR intervention. Learning satisfaction and self-confidence were first assessed after completion of the assigned educational interventions.
One month after the educational interventions, participants in both groups performed the enema administration procedure again on a low-fidelity patient mannequin. Skill performance, learning satisfaction, and self-confidence were reassessed using the same instruments.
After all follow-up assessments and data collection procedures had been completed, participants in the control group were also offered the opportunity to experience the HMD-based VR simulation to ensure educational equity. This delayed VR training was not included in the comparative outcome analyses.
Statistical Analysis
Data were analyzed using IBM SPSS Statistics version 25.0. Descriptive statistics were used to summarize participant characteristics and outcome measures. Distributional assumptions were assessed using the Shapiro-Wilk test and graphical methods. Depending on the characteristics of the data, chi-square tests, Fisher's exact tests, Mann-Whitney U tests, and paired-samples t-tests were used.
Analysis of covariance (ANCOVA) was performed to compare follow-up skill performance between the groups while adjusting for initial skill scores. Statistical significance was set at p<0.05.
Ethical Considerations
The study was approved by the Giresun University Medical Research Ethics Committee (April 15, 2026; Approval No. 04). Institutional permission was obtained, and written informed consent was provided by all participants before enrollment. The study was conducted in accordance with the principles of the Declaration of Helsinki.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study used a two-arm, parallel-group randomized controlled design. A total of 68 nursing students were randomly assigned to either the intervention group (n=34) or the control group (n=34) using a card-drawing method. Both groups received standardized theoretical and mannequin-based practical training in enema administration. The intervention group additionally received HMD-based virtual reality simulation training, whereas the control group received standard training only. Outcomes were assessed at the initial measurement and at one-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| HMD-Based Virtual Reality Simulation | Experimental | Other: HMD-Based Immersive Virtual Reality SimulationParticipants in the experimental group received standardized theoretical and practical training in enema administration, followed by an additional 10-15-minute HMD-based immersive virtual reality simulation session. The simulation provided an interactive environment for practicing and reinforcing enema administration skills. |
| Conventional Mannequin-Based Training | Active comparator | Other: HMD-Based Immersive Virtual Reality SimulationParticipants in the control group received standardized theoretical education, instructional video demonstration, and practical training using a low-fidelity patient mannequin. No HMD-based virtual reality simulation was provided during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being a first-year undergraduate nursing student enrolled in the Fundamentals of Nursing course for the first time.
- Voluntarily agreeing to participate in the study.
- Providing written informed consent.
Key exclusion criteria (3 listed)
- Having graduated from a healthcare vocational high school.
- Having previously graduated from an associate degree or undergraduate program in a health-related field.
- Having received previous theoretical or practical training in enema administration.
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 |
|---|---|---|
| HMD-Based Immersive Virtual Reality SimulationParticipants in the experimental group received an additional 10-15-minute immersive virtual reality training session using a head-mounted display (HMD). The interactive simulation enabled nursing students to practice enema administration procedures in a virtual clinical environment. This intervention was delivered following standardized theoretical and mannequin-based practical training. | Other | Conventional Mannequin-Based Training, HMD-Based Virtual Reality Simulation |
Primary outcome
Enema Administration Skill Performance
Time frame: After standard training (before VR intervention) and at one-month follow-up
Enema administration skill performance was assessed using a 30-item Enema Administration Skills Checklist. Each item was scored as performed (2 points), partially performed (1 point), or not performed (0 points). Total scores ranged from 0 to 60, with higher scores indicating better skill performance.
2 secondary outcomes
Student Satisfaction with Learning
Time frame: Immediately after the educational intervention and at one-month follow-up
Student Self-Confidence in Learning
Time frame: Immediately after the educational intervention and at one-month follow-up
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 27 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers. The study data will be maintained confidentially by the research team in accordance with institutional ethical requirements and participant confidentiality principles.
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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 HMD-Based Immersive Virtual Reality Simulation in people with Nursing Education, run by Giresun University 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 3 inclusion and 3 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 27 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?
Enema Administration Skill Performance (time frame: After standard training (before VR intervention) and at one-month follow-up). 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 27 Oct 2026.