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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (VR Group) | Experimental | 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. |
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| Control Group | Active Comparator | Participants received standard diabetic foot care without virtual reality intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care |
| Change in Oxygen Saturation (SpO₂) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malatya Turgut Özal University Training and Research Hospital | Malatya | Malatya | 4400 | Turkey (Türkiye) |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2026 | May 6, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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|
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| Standard Diabetic Foot Care | Other | 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. |
|
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. |
| 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. | 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. | 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. | 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. | Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |