- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07745946
The Effect of Virtual Reality Glasses and Breathing Exercise on Anxiety
The Effect of Virtual Reality Glasses and Breathing Exercise on Anxiety During Chemotherapy Treatment in Breast Cancer Patients: A Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Cancer remains one of the leading causes of morbidity worldwide, with anxiety recognized as one of the most frequently reported psychological symptoms among patients undergoing chemotherapy. In breast cancer patients specifically, anxiety has been shown to negatively affect quality of life, reduce treatment adherence, and intensify the perceived burden of other physical symptoms during chemotherapy sessions.
While pharmacological approaches remain part of standard symptom management, non-pharmacological interventions-such as distraction techniques, relaxation exercises, guided imagery, and music therapy-are increasingly used by nurses due to their low cost, safety, ease of implementation, and ability to actively engage patients in their own care. Among these, virtual reality (VR) technology has emerged as a promising distraction-based intervention, with prior studies reporting reductions in stress, anxiety, and treatment-related discomfort. Similarly, breathing exercises have demonstrated anxiolytic effects through their regulatory influence on the autonomic nervous system, with recent systematic reviews and meta-analyses confirming significant reductions in anxiety and depression among cancer patients.
Despite the individual evidence supporting each intervention, few studies have directly compared the effectiveness of virtual reality glasses and breathing exercises within the same patient population, and randomized controlled trials evaluating both interventions concurrently in breast cancer patients undergoing chemotherapy remain limited.
This study is designed as a randomized controlled trial to determine and compare the effects of virtual reality glasses and breathing exercise applications on anxiety levels in breast cancer patients receiving chemotherapy. Eligible participants will be randomly assigned to one of the study groups (virtual reality glasses, breathing exercise, or standard care/control), and anxiety will be assessed using a validated anxiety measurement instrument (State-Trait Anxiety Inventory, VAS) before and after the intervention during chemotherapy sessions.The findings of this study are expected to contribute to the evidence base for non-pharmacological anxiety management in oncology nursing practice and to help identify effective, low-cost interventions that can be integrated into routine chemotherapy care.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ankara, Turquie (Türkiye)
- Ankara Medipol University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Diagnosed with breast cancer
- Aged 18 years or older
- Receiving treatment in the outpatient (day-case) chemotherapy unit
- Voluntarily agreeing to participate in the study
Exclusion Criteria:
- Having a respiratory-related disease
- Having visual or hearing impairment
- Having a communication problem
- Having a diagnosis of psychiatric disease
- Having a cancer diagnosis other than breast cancer
- Receiving ice-cap therapy to prevent/reduce hair loss or cryotherapy for hand-foot neuropathy during chemotherapy treatment
- Having vertigo or head-neck disorders
- Patients hospitalized for their first cycle of chemotherapy treatment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Breathing Exercise Group
Breathing exercise applied during chemotherapy sessions
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Intervention 1: Breathing Exercise In this study, participants in the breathing exercise group will perform diaphragmatic (deep) breathing exercises during their chemotherapy sessions.
Diaphragmatic breathing promotes deeper, more controlled respiration through effective use of the diaphragm muscle, producing a balancing effect on the autonomic nervous system, while slow rhythmic breathing supports relaxation by increasing heart rate variability.
Participants will be guided by a nurse/researcher to perform the exercise for [10 minutes]
Autres noms:
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Expérimental: Virtual Reality Glasses Group
Use of virtual reality glasses during chemotherapy sessions
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Intervention 2: Virtual Reality Glasses Participants in the virtual reality group will wear VR glasses displaying calming, distraction-based visual and auditory content during their chemotherapy infusion.
This intervention aims to redirect attention away from the treatment process, thereby reducing perceived stress and anxiety.
The VR session will be applied for [10 minutes]
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Aucune intervention: Control (Standard Care)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Anxiety Level
Délai: Baseline (before intervention) and immediately after intervention during the chemotherapy session
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Anxiety levels will be measured using a validated anxiety assessment tool ( State-Trait Anxiety Inventory [STAI], VAS, Vital Signs form before and after the intervention (virtual reality glasses, breathing exercise, or standard care) in each study group.
The change in anxiety scores between baseline and post-intervention will be compared across the three groups.
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Baseline (before intervention) and immediately after intervention during the chemotherapy session
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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
- Les troubles mentaux
- Tumeurs par site
- Maladies de la peau
- Maladies du sein
- Maladies de la peau et du tissu conjonctif
- Tumeurs
- Troubles anxieux
- Tumeurs mammaires
- Thérapeutique
- Thérapies corps-esprit
- Thérapies complémentaires
- Techniques de mouvement d'exercice
- Modalités de physiothérapie
- Exercices de respiration
Autres numéros d'identification d'étude
- 2025-03/18
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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