An interventional study of VR and Standard Diabetic Foot Care in Diabetic Foot Ulcer, sponsored by Malatya Turgut Ozal University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Malatya Turgut Ozal University · Not applicable, Interventional, and Supportive care
This study aims to determine the effects of a virtual reality (VR) intervention on pain level, state anxiety, and vital signs during foot care in individuals with diabetic foot ulcers. The study was designed as a randomized controlled trial and includes 64 individuals with diabetes (intervention=32, control=32). The intervention group will receive VR during diabetic foot care, while the control group will receive standard care. Data will be collected at pre-test and post-test using the Demographic Information Form, Vital Signs Form, State-Trait Anxiety Inventory (STAI), and Visual Analog Scale (VAS) for pain. Data analysis will be performed using SPSS 22.0.
1,077 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 64 is close to the median of 60 across 847 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Malatya Turgut Ozal University is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants received virtual reality (VR) intervention during diabetic foot care procedures in addition to standard care. VR was used as a non-pharmacological distraction method during the procedure.
Other: VR · Other: Standard Diabetic Foot Care
Participants received standard diabetic foot care without virtual reality intervention.
Other: Standard Diabetic Foot Care
Participants in the intervention group received virtual reality (VR) exposure during diabetic foot care procedures. A virtual reality headset was used as a non-pharmacological distraction method to reduce pain and anxiety. The VR intervention was applied during the procedure in addition to standard diabetic foot care. Vital signs such as blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature were monitored before and after the procedure to evaluate physiological responses.
Also known as: VR GLASSES, Standard Diabetic Foot Care
Participants in the control group received standard diabetic foot care according to institutional protocols, without any virtual reality intervention. Vital signs including blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature were monitored before and after the procedure.
Change in Pain Level
Pain intensity measured using the Visual Analog Scale (VAS), a 10 cm horizontal line anchored at 0 (no pain) and 10 (worst imaginable pain). Higher scores indicate greater pain. Change is calculated as post-test score minus pre-test score.
Time frame: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
Change in State Anxiety
State anxiety measured using the State subscale of the State-Trait Anxiety Inventory (STAI-I), a validated 20-item self-report scale scored 20-80. Higher scores indicate greater anxiety. Change is calculated as post-test score minus pre-test score.
Time frame: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
Change in Body Temperature
Body temperature (°C) measured using a non-contact infrared thermometer (Life Net Medical JA-11C). Change is calculated as post-test value minus pre-test value.
Time frame: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
Change in Oxygen Saturation (SpO₂)
Peripheral oxygen saturation (SpO₂, %) measured using a fingertip pulse oximeter (Life Net Medical PFX033). Change is calculated as post-test value minus pre-test value.
Time frame: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
Change in Pulse Rate
Pulse rate (beats per minute) measured using a fingertip pulse oximeter (Life Net Medical PFX033). Change is calculated as post-test value minus pre-test value.
Time frame: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
Change in Respiratory Rate
Respiratory rate (breaths per minute) assessed by direct observation and counting by the researcher. Change is calculated as post-test value minus pre-test value.
Time frame: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
Change in Systolic Blood Pressure
Systolic blood pressure (mmHg) measured using an upper-arm automated sphygmomanometer (Omron M3 Comfort HEM-7155-E) after the participant had been seated and resting for at least 5 minutes. Change is calculated as post-test value minus pre-test value.
Time frame: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
Change in Diastolic Blood Pressure
Diastolic blood pressure (mmHg) measured using an upper-arm automated sphygmomanometer (Omron M3 Comfort HEM-7155-E) after the participant had been seated and resting for at least 5 minutes. Change is calculated as post-test value minus pre-test value.
Time frame: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data (IPD) will not be shared due to patient privacy and confidentiality concerns. The data are collected within a single institutional clinical study for academic thesis purposes and are not planned for public data sharing.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Malatya Turgut Ozal University