NCT06558292

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

August 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

August 14, 2024

Last Update Submit

August 15, 2024

Conditions

Keywords

Clinical practiceVirtual RealityNursing StudentsSimulationStressAnxietyOperating Room

Outcome Measures

Primary Outcomes (1)

  • 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).

    After Simulation Using Virtual Reality in clinical pratice. An average of 1 year.

Secondary Outcomes (1)

  • Change from confidence level in clinical practice

    After Simulation Using Virtual Reality in clinical pratice. An average of 1 year

Study Arms (2)

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

Other: Virtual Reality Group

Control Group

NO INTERVENTION

Anxiety and stress will be evaluated in clinical practice

Interventions

Students will experience the operating room environment with virtual reality glasses before clinical practice.

Virtual Reality Group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsHaving taken a course in surgical diseases nursing
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a second-year student at Gülhane Nursing Faculty of Health Sciences University
  • Agreeing to participate in the study

You may not qualify if:

  • Not completing any stage of the study
  • Wanting to withdraw from the study
  • Having previously taken the surgical disease nursing course

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Turkiye Gulhane Faculty of Nursing

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 16, 2024

Study Start

August 14, 2024

Primary Completion

October 31, 2024

Study Completion

December 1, 2024

Last Updated

August 16, 2024

Record last verified: 2024-08

Locations