Effect of Virtual Reality on Pain, Anxiety and Vital Signs During Diabetic Foot Care
7 mei 2026 bijgewerkt door: Yasemin Özkul, Malatya Turgut Ozal University
The Effect of Virtual Reality Intervention on Pain Level, State Anxiety, and Vital Signs During Foot Care in Individuals With Diabetic Foot Ulcers
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
64
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Malatya
-
Malatya, Malatya, Turkije (Türkiye), 4400
- Malatya Turgut Özal University Training and Research Hospital
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Age 18 years and older Diagnosis of Type 2 Diabetes Mellitus Diabetic foot ulcer classified as Wagner stage 3 or 4 No mental or physical condition that would interfere with communication or participation No visual or hearing impairment Ability to understand and speak Turkish Willingness to participate in the study
Exclusion Criteria:
- Presence of chronic wounds other than diabetic foot ulcer (e.g., arterial or venous ulcers) Age under 18 years
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Intervention Group (VR Group)
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.
|
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.
Andere namen:
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.
|
|
Actieve vergelijker: Control Group
Participants received standard diabetic foot care without virtual reality intervention.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Pain Level
Tijdsspanne: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in State Anxiety
Tijdsspanne: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
|
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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Body Temperature
Tijdsspanne: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
|
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)
Tijdsspanne: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
|
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
Tijdsspanne: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
|
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
Tijdsspanne: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
|
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
Tijdsspanne: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
|
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
Tijdsspanne: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
|
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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
9 december 2024
Primaire voltooiing (Werkelijk)
15 juni 2025
Studie voltooiing (Werkelijk)
15 juni 2025
Studieregistratiedata
Eerst ingediend
30 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
7 mei 2026
Eerst geplaatst (Werkelijk)
14 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
14 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
7 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neurologische manifestaties
- Endocriene systeemziekten
- Vaatziekten
- Hart-en vaatziekten
- Psychische aandoening
- Suikerziekte
- Diabetische angiopathieën
- Diabetes complicaties
- Huidziektes
- Huidzweer
- Beenzweer
- Diabetische neuropathieën
- Voetzweer
- Pathologische aandoeningen, tekenen en symptomen
- Huid- en bindweefselaandoeningen
- Tekenen en symptomen
- Pijn
- Angst stoornissen
- Diabetische voet
Andere studie-ID-nummers
- E-30785963-020-266758
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .