Clinical PracticeNCT06558292
The Effect of a Pre-Clinical Practice Simulation Using Virtual Reality Stress and Anxiety Levels
A study testing Virtual Reality Group in people with Clinical Practice and Virtual Reality, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
This study is designed as a randomized controlled trial to examine the effect of simulation practices using virtual reality headsets related to the operating room environment on nursing students' stress and anxiety levels before clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Practice, Virtual Reality, Nursing Education
- What is being tested?
- Virtual Reality Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Aug 2024to 1 Dec 2024
- Phase
- Interventional
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 second-year student at Gülhane Nursing Faculty of Health Sciences University
- Agreeing to participate in the study
Who cannot join
- Not completing any stage of the study
- Wanting to withdraw from the study
- Having previously taken the surgical disease nursing course
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Turkiye Gulhane Faculty of Nursing
Ankara
About this study
Official title: The Effect of a Pre-Clinical Practice Simulation Using Virtual Reality Stress and Anxiety Levels Among Nursing Students on Operating Room: A Randomised Controlled Trial
This study is designed as a randomized controlled trial to examine the effect of simulation practices using virtual reality headsets related to the operating room environment on nursing students' stress and anxiety levels before clinical practice.
Read the detailed description
Nursing education is a field that requires the integration of both clinical and theoretical training, as it is a practical discipline (Ryan et al., 2010; Özçelik \& Ayhan, 2021). Therefore, nurse educators must continuously innovate their teaching and learning methods at every stage of their students' educational journey (Fealy et al., 2019). The use of simulation in nursing education has been implemented for the past 50 years (Foronda et al., 2017). Simulation practices can reflect the characteristics of the real world, providing students with safe learning environments where they can practice until they achieve skill competence through feedback and self-correction (Aebersold, 2018; Shorey \& Ng, 2021). With the advancement of simulation technology over time, it is observed that the realism and authenticity of simulated environments have increased.
Upon reviewing the literature, no studies were found that evaluate the impact of simulation practices using virtual reality headsets related to the operating room environment on nursing students' stress and anxiety levels before clinical practice. Therefore, this study is planned to be conducted on nursing students. The results of this study are expected to contribute to educators in enhancing, planning, and managing the effectiveness of clinical education.
The study will conduct as a prospective randomized controlled trial. After obtaining verbal and written consent from the students before and after the clinical practice, the study will conduct with various data collection forms.
These forms are; Student Identification form, Spielberger's State and Trait Anxiety Inventory, Student Satisfaction and Self-Confidence in Learning Scale and Perceived Stress Scale for Nursing Students will be used, and Visual Analog Scale will be used to assess the general self-confidence of the students. Patients will randomize.
The Virtual Reality (VR) group in group- I (n=41), and group II (n=41) will be the control group. We have three stage. In first stage; anxiety levels will be measured for both groups. In second stage; Student Satisfaction and Self-Confidence in Learning Scale and anxiety levels will evaluated for the Virtual Reality (VR) group in group- I. In third stage; anxiety levels and Stress levels will be measured for both groups in clinical practice.
- Being tested
- Virtual Reality Group
- Keywords
- Clinical practice, Virtual Reality, Nursing Students, Simulation, Stress, Anxiety, Operating Room
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GroupOther
Students will experience the operating room environment with virtual reality glasses before clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Students will experience the operating room environment with virtual reality glasses before clinical practice.
Anxiety and stress will be evaluated in clinical practice Receives: Other: Virtual Reality Group |
| Control Group | No intervention | Anxiety and stress will be evaluated in clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from anxiety and stress level in clinical practice
The simulation application of the operating room environment with virtual reality glasses to nursing students before clinical practice will affect the stress and anxiety levels of the students in the operating room. This status will evaluate with Spielberger's State and Trait Anxiety Inventory and Perceived Stress Scale for Nursing Students Spielberger's State and Trait Anxiety Inventory consists of a total of 40 items, 20 for each scale. The first form in the inventory includes statements about state anxiety, and the second form includes statements about trait anxiety High scores indicate high anxiety levels. Perceived Stress Scale for Nursing Students consists of 29 items and 6 sub-dimensions. Total score is 0-116 (sub-dimension total scores are: 0-12, 0-32, 0-20, 0-24, 0-12, 0-16). Higher scores indicate higher levels of stress. (Sheu et al. 2002).
Measured: After Simulation Using Virtual Reality in clinical pratice. An average of 1 year.
Secondary outcomes (1)
Change from confidence level in clinical practice
In this section, the degree of confidence level will increase or not decrease . This status will evaluate with Visual Analogue Scale (VAS). VAS is a horizontal line with a length of 10 cm. According to VAS, 0 is the lowest level and 10 is the highest level.
Measured: After Simulation Using Virtual Reality in clinical pratice. An average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start14 Aug 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PracticeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Arici Parlak, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558292
- Sponsor's protocol ID
- 14141414
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No