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Sponsor: Dott.Claudio Sini
Conditions: Lung Neoplasms (D008175)
Interventions: Immersive Virtual Reality
Countries: Italy
The goal of this randomized clinical trial is to determine whether immersive virtual reality (VR), delivered during scheduled immunotherapy or chemo-immunotherapy infusions, can reduce state anxiety in patients with lung cancer compared with standard care. The main question this study aims to answer is whether participants assigned to the VR group will have a lower mean State-Trait Anxiety Inventory-State score (STAI-Y1) at week 9 than participants assigned to standard care. A total of 60 participants will be randomly assigned in a 1:1 ratio to receive either VR plus standard care or standard care alone. Participants assigned to the VR group will use immersive VR during four infusion visits: at baseline, week 3, week 6, and week 9. Each VR session will begin 15 minutes before the start of the infusion and may continue for the duration of the infusion. The study will also explore the effects of VR on objective tumor response, neutrophil-to-lymphocyte ratio, fatigue, pain, quality of life, dyspnea, and cough. Cybersickness, participant satisfaction, adverse reactions, and study withdrawal will also be assessed.
Sex: ALL
Age: 18 Months to 80 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Age older than 18 years * Diagnosis of lung cancer with an indication for intravenous immunotherapy or chemo-immunotherapy * Montreal Cognitive Assessment (MoCA) score of 26 or higher * No significant hearing impairment * No significant visual impairment * Sufficient ability to read and write in Italian Exclusion Criteria: * Use of antipsychotic medications * Epilepsy * Use of illicit drugs or alcohol
- Olbia, Sardinia, Italy