Development and Implementation Haptic VR Simulation (VR)

September 15, 2025 updated by: özlem doğu, Sakarya University

Development and Implementation of a Multi-Skill, Haptic-Supported Virtual Reality Simulation for Nursing Students

The goal of this experimental study is to increase objectivity in clinical decision-making and skill assessment of nursing students by using haptic-assisted virtual reality simulation, unlike imported products used in nursing education.

Hypotheses:

H1: There is a difference between the total psychomotor skill levels of the intervention and control group students in all relevant skill applications.

H2: There is a difference between the clinical decision-making score averages of the intervention and control group students.

Researchers will compare the effects of haptic-assisted virtual simulation training on psychomotor skill levels and clinical decision-making scores in the intervention and control groups.

Participants will:

  • Students who have agreed to participate in the study,
  • Students taking the Fundamentals of Nursing course for the first time,
  • Students with no prior simulation experience

Study Overview

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Serdivan
      • Sakarya, Serdivan, Turkey (Türkiye), 54200
        • Sakarya University Faculty of Health Sciences
        • Contact:
        • Contact:
        • Principal Investigator:
          • Özlem Doğu, PhD
        • Sub-Investigator:
          • Ramazan Bozkurt, MSc
        • Sub-Investigator:
          • Kayhan Ayar, PhD
        • Sub-Investigator:
          • Gülüzar Çit, PhD
        • Sub-Investigator:
          • Cemil Öz, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Students who have agreed to participate in the study,
  • Students taking the Fundamentals of Nursing course for the first time,
  • Students with no prior simulation experience

Exclusion Criteria:

  • Students who do not meet the inclusion criteria,
  • Students who do not complete the data collection forms in full,
  • Students who are retaking the Fundamentals of Nursing course will be excluded from the study.
  • Students who do not participate in the virtual reality application or laboratory application to be implemented during the study period, who are absent, or who wish to withdraw from the study will be excluded from the study during the follow-up period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Haptic-assisted virtual reality
The haptic-assisted virtual reality simulation developed for the intervention group will enable them to practice nursing skills.
The virtual reality application will be developed using the Unity game engine. The VR simulation environment, which will progress through scenarios, will include taking vital signs, performing aspiration, performing a nasogastric catheterization, oxygen therapy, performing physical examinations, and performing subcutaneous injections.
No Intervention: Control
Classic nursing skills education with task trainer in the nursing skills laboratory.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Decision Making, Self-Confidence, and Anxiety Assessment in Nursing
Time Frame: 1 month
This scale assesses nursing students' anxiety and self-confidence levels in clinical decision-making. Separate scores are obtained for self-confidence and anxiety from the scale, which consists of a total of 27 questions. Both the self-confidence and anxiety sections of the scale have three subscales: "Using resources to obtain information and listening carefully (13 questions)", "Using available information to identify the problem (7 questions)", and "Knowing and taking action (7 questions)". Higher scores on self-confidence and its subdimensions indicate increased levels of self-confidence in clinical decision-making among students. Low scores on the anxiety section and its subdimensions indicate low levels of anxiety in clinical decision-making. It is a six-point Likert-type scale. The lowest possible score on the self-confidence and anxiety sections is 27, and the highest possible score is 162.
1 month
Knowledge Test
Time Frame: 1 month
The Knowledge Test, prepared in line with the literature, consists of 20 questions. Each question will be scored with "1" point for a correct answer and "0" points for an incorrect answer. Questions covering all skill applications will be scored out of 100, with the total number of correct answers completing the score. The form was evaluated by ten experts in the field of Nursing Fundamentals outside of the study and finalized. The purpose of the expert opinion is to examine the items according to criteria such as whether the test measures behavior according to its structure, its comprehensibility in terms of language, whether there are scientific errors, grammatical errors, and the suitability of the items for the group to be applied to, and to make the necessary corrections.
1 month
Performance evaluation
Time Frame: 1 month
The performance report, which awards points out of 100, will include scoring for nursing interventions. Performance report scores range from 0 to 100; minimum score "0", maximum score "100". The performance report applied with the task trainer has been created to be identical to the virtual patient simulation performance report, and OSCE steps have been defined. The performance forms created will be evaluated by the researcher during the student's application. All students (intervention and control groups) will use the application at least once within the scope of the study. For the success assessment in the applications, the cutoff score is considered as follows: 50.00-59.99 is passing, 60.00-69.99 is average, 70.00-84.99 is good, and 85.00-100 is excellent. A higher score indicates higher performance.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

September 9, 2025

First Submitted That Met QC Criteria

September 9, 2025

First Posted (Estimated)

September 16, 2025

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • E-61923333-050.99-285112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There are plans to make the IPD and related data dictionaries available for use. Researchers may share the data upon request after the study is published.

IPD Sharing Time Frame

After the study is published, researchers may share the data for a period of three years upon request.

IPD Sharing Access Criteria

Researchers in the field of nursing may contact the researchers of this study to request the data.

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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