Effectiveness of Immersive Virtual Reality in Patients With Cancer

Effectiveness of Immersive Virtual Reality in Patients With Cancer Undergoing Chemotherapy: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain; Cancer; Fatigue; Anxiety; Chemotherapy Effect
• Intervention / Treatment: Device: Virtual Reality

Detailed Description

This study is a three-arms randomized controlled trial that will be conducted at St Giovanni Paolo II Hospital, Olbia (Italy), from July 2022 to November 2022. This RCT, is an open-label trial, longitudinal, pre-post test, with balanced allocation ratio 1: 1: 1, monocentric, in patients with cancer undergoing intravenous chemotherapy.

Patients will be randomly allocated into three groups: 1) Virtual Reality group; 2) Narrative Medicine group; 3) Standard Care group.

Primary outcome is Anxiety, measured with State-Trait Anxiety Inventory. Secondary outcomes are: 1) fatigue measured with Revised Piper Fatigue Scale; 2) pain measured with Visual Analogic Scale; 3) Adverse effects, measured as manifestation of nausea, vomiting, needle phobia; 4) Symptoms of cybersickness will be measured with Reality Symptom Questionnaire.The study will conduct in accordance with the ethical standards as laid down in the Declaration of Helsinki, with the protocol approved by the Ethics Committee (Trial registration number: RS 97/CE). A written informed consent will obtain from all patients included in the study.

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.The Virtual Reality headset 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).

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Sassari
    • Olbia, Sassari, Italy, 07026
      • Salvatore Ortu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age> 18 years;
• diagnosis of cancer with indication for intravenous chemotherapy;
• cognitively able to participate;
• no significant acoustic deficit;
• no significant visual impairment;
• sufficient ability to write and read in Italian.

Exclusion Criteria:

• use of antipsychotic drugs;
• epilepsy;
• use of drugs or alcohol;
• metastatic cancer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; 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.	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).
No Intervention: Narrative Medicine; 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.
No Intervention: Standard Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change is being assessed for Anxiety	Anxiety is assessed with State-Trait Anxiety Inventory.The minimum value is 20 and the maximum value is 80, whether higher scores mean a worsening of anxiety.	Baseline, pre-intervention and immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Fatigue	Fatigue is assessed with Revised Piper Fatigue Scale. The minimum value is 0 and the maximum value is 10, whether higher scores mean a worsening of fatigue.	Baseline, pre-intervention and immediately after the intervention
Assessment of Pain	Pain is assessed with Visual Analogic Scale.The minimum total score is 0 and the maximum is 10, whether higher scores mean a worsening of pain.	Baseline, pre-intervention and immediately after the intervention
Number of partecipants with Adverse effects	Adverse effects are assessed as number of partecipants with nausea, vomiting, needle phobia.	Baseline, pre-intervention and immediately after the intervention
Number of partecipants with a therapeutic adherence	The therapeutic adherence is assessed as number of partecipants with a reduction,delay, or discontinuation of chemotherapy administration.	Baseline, pre-intervention and immediately after the intervention

Collaborators and Investigators

• Sponsor: ASL Gallura - Ospedale Giovanni Paolo II
• Investigators: Principal Investigator: Salvatore Ortu, Dr, Oncology Unit, Giovanni Paolo II Hospital, Olbia,Italy

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): November 16, 2022

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Pain; Anxiety; Fatigue; Virtual Reality; Chemotherapy
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: VROM_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No