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Effectiveness of Immersive Virtual Reality in Patients With Cancer

NCT05629507 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2022-11-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Virtual Reality

The Virtual Reality intervention will administer through the use of a Virtual Reality headset. The multimedia contents in VR, will have a video quality from 4K to 8K, 360 degrees, and HD audio stereo. The scenarios are classified into 12 categories: 1) Artistic cities (60 scenarios); 2) Africa (17 scenarios); 3) Hills (26 scenarios); 4) Rivers, lakes and waterfalls (43 scenarios); 5) Sardinia (13 scenarios); 6) Deserts (21 scenarios); 7) Beaches (20 scenarios); 8) Animals (20 scenarios); 9) Mountains (25 scenarios); 10) Concerts (21 scenarios); 11) Sea (24 scenarios); 12) submarine (20 scenarios).

Sponsors & Collaborators

  • ASL Gallura - Ospedale Giovanni Paolo II

    lead OTHER

Principal Investigators

  • Salvatore Ortu, Dr · Oncology Unit, Giovanni Paolo II Hospital, Olbia,Italy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2022-10-30
Completion
2022-11-16

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05629507 on ClinicalTrials.gov