Clinical trial NCT05629507: Effectiveness of Immersive Virtual Reality in Patients With Cancer
Official title: Effectiveness of Immersive Virtual Reality in Patients With Cancer Undergoing Chemotherapy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Chemotherapy Effect
Anxiety
Fatigue
Pain
Keywords: Virtual Reality
Cancer
Chemotherapy
Anxiety
Fatigue
Pain
Lead sponsor: ASL Gallura - Ospedale Giovanni Paolo II
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change is being assessed for Anxiety
timeFrame: Baseline, pre-intervention and immediately after the intervention
Secondary outcomes:
measure: Assessment of Fatigue
timeFrame: Baseline, pre-intervention and immediately after the intervention
measure: Assessment of Pain
timeFrame: Baseline, pre-intervention and immediately after the intervention
measure: Number of partecipants with Adverse effects
timeFrame: Baseline, pre-intervention and immediately after the intervention
measure: Number of partecipants with a therapeutic adherence
timeFrame: Baseline, pre-intervention and immediately after the intervention
Other outcomes:
Locations:
city: Olbia
country: Italy
facility: Salvatore Ortu
state: Sassari
Study officials:
affiliation: Oncology Unit, Giovanni Paolo II Hospital, Olbia,Italy
name: Salvatore Ortu, Dr
role: PRINCIPAL_INVESTIGATOR
References: