NCT05629507

Effectiveness of Immersive Virtual Reality in Patients With Cancer

Completed NA Last updated 29 November 2022

What this trial tests

NA trial testing Virtual Reality in Cancer in 74 participants. Completed in 16 November 2022.

Timeline

1 July 2022

Primary endpoint
30 October 2022

16 November 2022

Quick facts

Lead sponsor	ASL Gallura - Ospedale Giovanni Paolo II
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	74
Start date	1 July 2022
Primary completion	30 October 2022
Estimated completion	16 November 2022
Sites	1 location across Italy

Drugs / interventions tested

• Virtual Reality

Conditions studied

• Cancer — all drugs for Cancer →
• Chemotherapy Effect — all drugs for Chemotherapy Effect →
• Anxiety — all drugs for Anxiety →
• Fatigue — all drugs for Fatigue →

Sponsor

ASL Gallura - Ospedale Giovanni Paolo II

Who can join

18 and older, any sex, with Cancer or Chemotherapy Effect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to study the effects of Immersive Virtual Reality in patients with cancer undergoing chemotherapy.

The main questions it aims to answer are:

* Could the immersive virtual reality application prevents or reduces anxiety, prevents or reduces fatigue, prevents or reduces pain, improves therapeutic adherence, prevents or reduces adverse events, then cancer patients treated with narrative medicine, and then cancer patients in standard care only?
* Could the immersive virtual reality application show symptoms of cybersickness?

Participants will be randomly allocated with balanced allocation ratio 1: 1: 1 into three groups: 1) Virtual Reality group; 2) Narrative medicine group; 3) Standard care group.

In the virtual reality arm, patients will use a Virtual Reality headset. The multimedia contents in VR, will have a video quality from 4K to 8K, 360 degrees, and High Definition audio stereo.

In control arm, patients will be free to choose different activities during the infusion of chemotherapy, such as conversation with nurses, doctors, trainees, reading, writing, watching television, listening to music or videos on their smartphone.

In narrative medicine arm, patients will express their subjective experience regarding to the chemotherapy through writing. The experience will be written in free form by the patient and will cover both the cognitive, emotional and perceptual aspects. A nurse will always be available to guide the patient in the activity of expressing cognitive, emotional and perceptual contents.

Researchers will compare the Virtual Reality group, Narrative Medicine group, Standard care group, to see the effects regarding to anxiety, fatigue, pain, improves therapeutic adherence and adverse events.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effectiveness of Immersive Virtual Reality in People with Cancer Undergoing Antiblastic Therapy: A Randomized Controlled Trial.
   Burrai F, Ortu S, Marinucci M, De Marinis MG, et al · · 2023 · cited 21× · PMID 37455151 · DOI 10.1016/j.soncn.2023.151470
2. Using Virtual Reality to Improve Outcomes Related to Quality of Life Among Older Adults With Serious Illnesses: Systematic Review of Randomized Controlled Trials.
   Maheta B, Kraft A, Interrante N, Fereydooni S, et al · · 2025 · cited 10× · PMID 40009834 · DOI 10.2196/54452