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Effect of Virtual Reality on Pain, Anxiety and Vital Signs During Diabetic Foot Care

7. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

64

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • Malatya
      • Malatya, Malatya, Tyrkiet (Türkiye), 4400
        • Malatya Turgut Özal University Training and Research Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: VR
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 navne:
  • VR GLASSES
  • Standard Diabetic Foot Care
Andet: 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.
Aktiv komparator: Control Group
Participants received standard diabetic foot care without virtual reality intervention.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pain Level
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in State Anxiety
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Body Temperature
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Malatya Turgut Ozal University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. december 2024

Primær færdiggørelse (Faktiske)

15. juni 2025

Studieafslutning (Faktiske)

15. juni 2025

Datoer for studieregistrering

Først indsendt

30. april 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • E-30785963-020-266758

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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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