Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

7. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

64

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Türkei (türkiye)
    • Malatya
      • Malatya, Malatya, Türkei (türkiye), 4400
        • Malatya Turgut Özal University Training and Research Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: 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.
Andere Namen:
  • VR GLASSES
  • Standard Diabetic Foot Care
Sonstiges: 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.
Aktiver Komparator: Control Group
Participants received standard diabetic foot care without virtual reality intervention.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Pain Level
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in State Anxiety
Zeitfenster: 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 Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Body Temperature
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Malatya Turgut Ozal University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

9. Dezember 2024

Primärer Abschluss (Tatsächlich)

15. Juni 2025

Studienabschluss (Tatsächlich)

15. Juni 2025

Studienanmeldedaten

Zuerst eingereicht

30. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Mai 2026

Zuerst gepostet (Tatsächlich)

14. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • E-30785963-020-266758

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren