Effect of Virtual Reality During Femoral Sheath Removal
The Effect of Virtual Reality Glasses During Femoral Sheath Removal on Pain, Anxiety, and Vital Signs in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Percutaneous coronary intervention is a commonly used invasive procedure in the diagnosis and treatment of coronary artery disease. Femoral sheath removal performed after the procedure may cause pain, anxiety, and hemodynamic changes in patients. Non-pharmacological interventions are increasingly used to improve patient comfort and reduce procedure-related stress.
Virtual reality technology is considered an effective distraction method that may reduce pain perception and anxiety by directing patients' attention to immersive visual and auditory stimuli. Previous studies have demonstrated the positive effects of virtual reality applications during invasive and painful procedures.
This randomized controlled study aimed to investigate the effect of virtual reality glasses used during femoral sheath removal on pain, anxiety, and vital signs in patients undergoing percutaneous coronary intervention. Patients were randomly assigned to either the intervention group receiving virtual reality application during femoral sheath removal or the control group receiving standard care. Pain intensity, anxiety levels, and vital signs were evaluated before, during, and after the procedure.
The findings of this study may contribute to evidence-based nursing interventions aimed at improving patient comfort during femoral sheath removal procedures.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Hatay
-
İskenderun, Hatay, Turquie (Türkiye)
- İskenderun Devlet Hastanesi
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Patients aged 18 years and older
- Patients undergoing percutaneous coronary intervention via femoral access
- Patients with only one femoral sheath catheter
- Patients who did not receive analgesic medication before sheath removal
- Patients without severe hemorrhage or major hematoma at the femoral sheath site
- Patients able to communicate in Turkish
- Patients without visual, hearing, or speech impairment
- Patients without mental impairment affecting communication
- Patients without psychiatric diagnosis and not using psychiatric medication
Exclusion Criteria:
Patients unwilling to participate or wishing to withdraw from the study at any stage
- Patients who removed the virtual reality glasses during the intervention
- Patients who experienced intolerance to virtual reality application (e.g., dizziness or nausea)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Virtual Reality Group
Participants received virtual reality glasses during femoral sheath removal
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Virtual reality glasses were used during femoral sheath removal.
|
|
Autre: Control Group
Participants received routine care during femoral sheath removal
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Participants received routine care during femoral sheath removal
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Heart Rate
Délai: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
|
Heart rate was measured in beats per minute using routine monitoring.
|
Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
|
|
Blood Pressure
Délai: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
|
Systolic blood pressure and diastolic blood pressure were measured in mmHg using routine monitoring.
|
Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
|
|
Oxygen Saturation
Délai: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
|
Oxygen saturation was measured as percent saturation using pulse oximetry.
|
Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
|
|
Body Temperature
Délai: 5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
|
Body temperature was assessed using routine vital sign monitoring.
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5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
|
|
Pain Level
Délai: 5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
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Pain level was assessed using the Numeric Rating Scale (NRS).
The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates severe pain.
Higher scores indicate greater pain severity.
|
5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
|
|
Anxiety Level
Délai: Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal
|
Anxiety level was assessed using the State Anxiety Inventory (STAI).
Higher scores indicate higher anxiety levels.
|
Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HKU-2025/069
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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