Effectiveness of Immersive Virtual Reality in Patients With Cancer

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05629507
• Other study ID #: VROM_01
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: November 16, 2022

Study information

• Verified date: November 2022
• Source: ASL Gallura - Ospedale Giovanni Paolo II
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 16, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Cancer
• Chemotherapy Effect
• Fatigue
• Pain

Intervention

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).

Locations

Country	Name	City	State
Italy	Salvatore Ortu	Olbia	Sassari

Sponsors (1)

Lead Sponsor	Collaborator
ASL Gallura - Ospedale Giovanni Paolo II

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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