Effect of Virtual Reality on Pain, Anxiety and Vital Signs During Diabetic Foot Care
7. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
64
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Malatya
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Malatya, Malatya, Tyrkia (Türkiye), 4400
- Malatya Turgut Özal University Training and Research Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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.
Andre navn:
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.
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Aktiv komparator: Control Group
Participants received standard diabetic foot care without virtual reality intervention.
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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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Pain Level
Tidsramme: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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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.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in State Anxiety
Tidsramme: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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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
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Body Temperature
Tidsramme: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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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.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Change in Oxygen Saturation (SpO₂)
Tidsramme: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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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.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Change in Pulse Rate
Tidsramme: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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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.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Change in Respiratory Rate
Tidsramme: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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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.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Change in Systolic Blood Pressure
Tidsramme: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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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.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Change in Diastolic Blood Pressure
Tidsramme: Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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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.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
9. desember 2024
Primær fullføring (Faktiske)
15. juni 2025
Studiet fullført (Faktiske)
15. juni 2025
Datoer for studieregistrering
Først innsendt
30. april 2026
Først innsendt som oppfylte QC-kriteriene
7. mai 2026
Først lagt ut (Faktiske)
14. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Sykdommer i det endokrine systemet
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Psykiske lidelser
- Sukkersyke
- Diabetiske angiopatier
- Diabetes komplikasjoner
- Hudsykdommer
- Hudsår
- Bensår
- Diabetiske nevropatier
- Fotsår
- Patologiske tilstander, tegn og symptomer
- Hud- og bindevevssykdommer
- Tegn og symptomer
- Smerte
- Angstlidelser
- Diabetisk fot
Andre studie-ID-numre
- E-30785963-020-266758
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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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Nei
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