- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07361835
Evaluation of the Effectiveness of Using Virtual Reality Glasses in Prehospital Intervention Training for Crush Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Süreyya GÜMÜŞSOY, Assoc. Prof.
- Phone Number: +90 232 311 20 58
- Email: sureyya.gumussoy@ege.edu.tr
Study Contact Backup
- Name: Ali AKGÜN, PhD(c)
- Phone Number: +90 252 211 59 03
- Email: aliakgun1980@gmail.com
Study Locations
-
-
-
Muğla, Turkey (Türkiye), 48300
- Muğla Sıtkı Koçman University, Fethiye Health Services Vocational School
-
Contact:
- Süreyya GÜMÜŞSOY, Assoc. Prof.
- Phone Number: +90 232 311 20 58
- Email: sureyya.gumussoy@ege.edu.tr
-
Contact:
- Ali AKGÜN, PhD(c)
- Phone Number: +90 252 211 59 03
- Email: aliakgun1980@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Being a second-year student currently enrolled in the first and emergency aid program at Muğla Sıtkı Koçman University.
Voluntarily providing written informed consent to participate in the study. Having basic technological literacy to use virtual reality equipment.
Exclusion Criteria:
First-year students who have not yet reached the relevant stage of the curriculum.
Students who have previously participated in a similar virtual reality-based crush syndrome simulation.
Students with medical conditions that may be aggravated by VR use (e.g., severe motion sickness, history of seizures).
Refusal to participate voluntarily.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual reality-based crush syndrome training
Participants receive scenario-based three-dimensional virtual reality simulation training for prehospital crush syndrome management using a head-mounted display.
|
A scenario-based three-dimensional virtual reality training program focusing on prehospital crush syndrome assessment and management.
|
|
Active Comparator: Traditional classroom-based theoretical lecture
Participants receive traditional classroom-based theoretical education for prehospital crush syndrome management.
|
Conventional theoretical classroom instruction on prehospital crush syndrome assessment and management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prehospital crush syndrome knowledge level
Time Frame: Baseline (pre-test) and immediately after the training session (post-test).
|
The knowledge level of participants is measured using the full 'prehospital crush syndrome knowledge level scale'.
The scale consists of 32 items covering four sub-dimensions: general knowledge (12 items), treatment (9 items), transport (6 items), and advanced knowledge (5 items).
Each correct answer is scored as 1 point, while incorrect or 'no idea' answers are scored as 0. The total score ranges from a minimum of 0 to a maximum of 32.
A higher total score indicates a better understanding and a higher knowledge level of prehospital crush syndrome management.
|
Baseline (pre-test) and immediately after the training session (post-test).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Educational satisfaction level
Time Frame: Immediately after completion of the training intervention.
|
Participant satisfaction with the educational method (virtual reality or theoretical lecture) is measured using the 'education method satisfaction form'.
This is a single-item numeric rating scale ranging from a minimum of 0 to a maximum of 10.
A score of '0' indicates that the participant is not at all satisfied with the teaching method, while higher scores indicate increasing levels of satisfaction, with a score of '10' representing full satisfaction.
Higher scores mean a better outcome.
|
Immediately after completion of the training intervention.
|
|
Sense of presence in virtual environment
Time Frame: Immediately after completion of the virtual reality training session
|
The sense of presence in the virtual reality environment is measured using the 'presence questionnaire'.
This scale assesses various dimensions such as involvement, sensory fidelity, and adaptation.
Each item is scored on a 5-point likert scale, ranging from a minimum of 1 to a maximum of 5.
For instance, a score of '1' indicates no presence or very poor quality, while a score of '5' indicates a high level of presence or complete naturalness.
A higher total score indicates a greater sense of presence and a more immersive virtual reality experience.
|
Immediately after completion of the virtual reality training session
|
|
Technology usage level
Time Frame: Baseline (pre-test)
|
Participants' orientation and interest towards technology are measured using the 'technology usage scale'.
This scale consists of 13 items scored on a 5-point likert scale (1 = strongly disagree to 5 = strongly agree).
The total score ranges from a minimum of 13 to a maximum of 65.
A higher total score indicates a higher level of technology integration, interest, and adaptation to technological innovations in daily life.
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Baseline (pre-test)
|
|
Attitude toward virtual reality in education
Time Frame: Immediately after completion of the training session
|
Participants' attitudes toward using virtual reality for learning and professional development are measured using the 'virtual reality attitude scale'.
The scale consists of 9 items scored on a 5-point likert scale (1 = strongly disagree to 5 = strongly agree).
The total score ranges from a minimum of 9 to a maximum of 45.
A higher total score indicates a more positive attitude and higher perceived usefulness regarding the integration of virtual reality into educational processes
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Immediately after completion of the training session
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Süreyya GÜMÜŞSOY, Ege University
- Principal Investigator: Süreyya GÜMÜŞSOY, PhD, Ege University
Publications and helpful links
General Publications
- English: Gunduz, F., & Ersoy, G. (2022). Knowledge levels of 112 ambulance service employees regarding field treatment of crush syndrome: Izmir province example. Journal of Prehospital, 7(1), 37-50.
- English: Panus, U. (2023). Development of an education program to increase the level of knowledge about crush syndrome in paramedic students. Unpublished Master's Thesis, Ege University.
- Usuda D, Shimozawa S, Takami H, Kako Y, Sakamoto T, Shimazaki J, Inoue J, Nakayama S, Koido Y, Oba J. Crush syndrome: a review for prehospital providers and emergency clinicians. J Transl Med. 2023 Aug 31;21(1):584. doi: 10.1186/s12967-023-04416-9.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-11.1T/50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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