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
- 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 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06558292
- Acronym / sponsor ID
- 14141414
- Keywords
- Clinical practice, Virtual Reality, Nursing Students, Simulation, Stress, Anxiety, Operating Room
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 16 Aug 2024 (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 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Other: Virtual Reality GroupStudents will experience the operating room environment with virtual reality glasses before clinical practice. Anxiety and stress will be evaluated in clinical practice |
| Control Group | No intervention | –Anxiety and stress will be evaluated in clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being a second-year student at Gülhane Nursing Faculty of Health Sciences University
- Agreeing to participate in the study
Key exclusion criteria (3 listed)
- Not completing any stage of the study
- Wanting to withdraw from the study
- Having previously taken the surgical disease nursing course
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 |
|---|---|---|
| Virtual Reality GroupStudents will experience the operating room environment with virtual reality glasses before clinical practice. | Other | Virtual Reality Group |
Primary outcome
Change from anxiety and stress level in clinical practice
Time frame: After Simulation Using Virtual Reality in clinical pratice. An average of 1 year.
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).
1 secondary outcome
Change from confidence level in clinical practice
Time frame: After Simulation Using Virtual Reality in clinical pratice. An average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
Related trials for Clinical Practice
Not yet recruiting
Implementing IVM for Fertility Treatment in Clinical Practice
Infertility
Active, not recruitingPhase 3
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
Early Breast Cancer
Enrolling by invitationObservational study
An Observational Study Comparing Delandistrogene Moxeparvovec (ELEVIDYS) With Standard of Care in Participants With Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy
Active, not recruiting
Efficacy of Counselling for the Prevention of Hypertension (ECoPH)
Hypertension, Cardiovascular Diseases
Not yet recruiting
Artificial Intelligence (AI)-Initiated Clinical Decision Support in Hospitalist Practice
Clinical Decision Support
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 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).
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 2 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. 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?
Results are not available in the source record.
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?
Change from anxiety and stress level in clinical practice (time frame: After Simulation Using Virtual Reality in clinical pratice. An average of 1 year.). 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 16 Aug 2024.