NCT07175467

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

September 9, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

nursingvirtual realityskills trainingclinical decision makinghaptic

Outcome Measures

Primary Outcomes (3)

  • Clinical Decision Making, Self-Confidence, and Anxiety Assessment in Nursing

    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

    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

    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

Study Arms (2)

Haptic-assisted virtual reality

EXPERIMENTAL

The haptic-assisted virtual reality simulation developed for the intervention group will enable them to practice nursing skills.

Other: Haptic-asissted virtual simulation

Control

NO INTERVENTION

Classic nursing skills education with task trainer in the nursing skills laboratory.

Interventions

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.

Haptic-assisted virtual reality

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Faculty of Health Sciences

Sakarya, Serdivan, 54200, Turkey (Türkiye)

Location

Related Publications (6)

  • White KA. Development and validation of a tool to measure self-confidence and anxiety in nursing students during clinical decision making. J Nurs Educ. 2014 Jan 1;53(1):14-22. doi: 10.3928/01484834-20131118-05. Epub 2013 Nov 18.

    PMID: 24256004BACKGROUND
  • Park S, Hur HK, Chung C. Learning effects of virtual versus high-fidelity simulations in nursing students: a crossover comparison. BMC Nurs. 2022 Apr 27;21(1):100. doi: 10.1186/s12912-022-00878-2.

    PMID: 35473614BACKGROUND
  • Butt, A. L., Kardong-Edgren, S., & Ellertson, A. (2018). Using game-based virtual reality with haptics for skill acquisition. Clinical Simulation in Nursing, 16, 25-32.

    BACKGROUND
  • Sundler AJ, Pettersson A, Berglund M. Undergraduate nursing students' experiences when examining nursing skills in clinical simulation laboratories with high-fidelity patient simulators: A phenomenological research study. Nurse Educ Today. 2015 Dec;35(12):1257-61. doi: 10.1016/j.nedt.2015.04.008. Epub 2015 Apr 25.

    PMID: 25943280BACKGROUND
  • Sanders, D. (2010). Comparing ability to complete simple tele-operated rescue or maintenance mobile-robot tasks with and without a sensor system. Sensor Review, 30(1), 40-50.

    BACKGROUND
  • Kim, S. Y., Han, H. G., Kim, J. W., Lee, S., & Kim, T. W. (2017). A hand gesture recognition sensor using reflected impulses. IEEE Sensors Journal, 17(10), 2975-2976.

    BACKGROUND

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Manager

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 16, 2025

Study Start

October 1, 2025

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
SAP
Time Frame
After the study is published, researchers may share the data for a period of three years upon request.
Access Criteria
Researchers in the field of nursing may contact the researchers of this study to request the data.

Locations