AzTrials
AzTrials

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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07899008
Study groupRoleWhat they receive
HMD-Based Virtual Reality SimulationExperimentalParticipants 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 TrainingActive comparatorParticipants 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted27 Oct 2026
  2. Study start24 Apr 2026
  3. Primary completion29 May 2026
  4. Study completion29 May 2026

Resources

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)
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.

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in