Effect of Virtual Reality on Pain, Anxiety and Vital Signs During Diabetic Foot Care
7 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
64
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Malatya
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Malatya, Malatya, Turquie (Türkiye), 4400
- Malatya Turgut Özal University Training and Research Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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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Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Pain Level
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in State Anxiety
Délai: 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.
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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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Body Temperature
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
9 décembre 2024
Achèvement primaire (Réel)
15 juin 2025
Achèvement de l'étude (Réel)
15 juin 2025
Dates d'inscription aux études
Première soumission
30 avril 2026
Première soumission répondant aux critères de contrôle qualité
7 mai 2026
Première publication (Réel)
14 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies du système endocrinien
- Maladies vasculaires
- Maladies cardiovasculaires
- Les troubles mentaux
- Diabète sucré
- Angiopathies diabétiques
- Complications du diabète
- Maladies de la peau
- Ulcère de la peau
- Ulcère de jambe
- Neuropathies diabétiques
- Ulcère du pied
- Conditions pathologiques, signes et symptômes
- Maladies de la peau et du tissu conjonctif
- Signes et symptômes
- La douleur
- Troubles anxieux
- Pied diabétique
Autres numéros d'identification d'étude
- E-30785963-020-266758
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .