Authors
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Azienda Socio-Sanitaria Locale n. 2 della Gallura -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2026
Immersive virtual reality is a non‐pharmacological intervention that may support patientsduring cancer treatment by redirecting attention away from the hospital environment andpromoting distraction, presence, immersion, and interaction. Evidence on the effects ofimmersive VR specifically in patients with lung cancer receiving immunotherapy orchemo‐immunotherapy remains limited. This study is designed to evaluate the efficacy andsafety of VR in this clinical population.This is a single‐center, prospective, randomized, controlled, two‐parallel‐groupsuperiority trial. A total of 60 participants will be allocated in a 1:1 ratio to eitherthe Virtual Reality Group or the Standard Care Group. The randomization sequence will begenerated using validated software by an independent researcher who is not involved inparticipant recruitment or outcome assessment.At baseline, eligibility will be assessed and written informed consent will be obtainedbefore any study‐specific procedure. Sociodemographic and clinical information andbaseline outcome measurements will then be collected. Participants will be randomizedafter completion of the baseline assessments and before the start of the scheduledinfusion.Participants assigned to the Virtual Reality Group will receive usual clinical care plusimmersive VR. The intervention will be delivered using a standalone Meta Quest 3S 128 GBhead‐mounted display containing offline 360‐degree audiovisual content. The virtualenvironments will primarily include natural settings, such as hills, rivers, lakes,waterfalls, islands, deserts, beaches, mountains, marine environments, and underwaterenvironments.Before the first session, a healthcare professional trained in the study protocol willexplain how to use the VR equipment and how to select content from the availableplaylist. During each session, the participant will be seated in an infusion chair orlying on a treatment bed. The trained healthcare professional will place the headsetapproximately 15 minutes before the start of the infusion.Participants will be free to select the virtual content they prefer, adjust the audiovolume, and move their eyes and head normally. They may remove the headset at any timeand may subsequently resume the VR experience. The VR session may continue for theduration of the infusion. VR sessions will be conducted at baseline, week 3, week 6, andweek 9.Participants assigned to the Standard Care Group will receive the usual clinical andnursing care provided during immunotherapy or chemo‐immunotherapy infusions. Thisincludes pre‐treatment clinical and nursing assessment, administration of the prescribedtreatment, monitoring of clinical parameters and infusion‐related reactions, andmanagement of symptoms or adverse events according to routine clinical practice.Participants may talk, rest, use their own telephone, or watch television during theinfusion, but they will not use a VR headset or immersive content provided by the study.The primary outcome is state anxiety, assessed using the State‐Trait AnxietyInventory‐State subscale (STAI‐Y1) at baseline and at week 9. The primary hypothesis isthat participants assigned to VR will have a lower mean STAI‐Y1 score at week 9 thanparticipants assigned to standard care.Secondary exploratory outcomes include objective response rate, neutrophil‐to‐lymphocyteratio, fatigue, pain, quality of life, dyspnea, and cough. Cybersickness will be assessedfollowing the VR sessions, and satisfaction with VR will be evaluated at week 9. Adversereactions, participant withdrawals, and reasons for withdrawal will also be recorded.
Epistemonikos ID: 541d7b688acc1d1e139ad674737f5e7336488e65
First added on: Aug 11, 2026