Effectiveness of Immersive Virtual Reality in Patients With Cancer

NCT05629507 | Completed

• 1 other identifier: VROM_01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Chemotherapy Effect; Anxiety; Fatigue; Pain

Keywords

Virtual Reality; Cancer; Chemotherapy; Anxiety; Fatigue; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assessment of Fatigue

  Baseline, pre-intervention and immediately after the intervention

• Assessment of Pain

  Baseline, pre-intervention and immediately after the intervention

• Number of partecipants with Adverse effects

  Baseline, pre-intervention and immediately after the intervention

• Number of partecipants with a therapeutic adherence

  Baseline, pre-intervention and immediately after the intervention

Study Arms (3)

Virtual Reality

EXPERIMENTAL

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

Narrative Medicine

NO INTERVENTION

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.

Standard Care

NO INTERVENTION

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.

Interventions

Virtual Reality DEVICE

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).

Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• ASL Gallura - Ospedale Giovanni Paolo II: lead

Study Sites (1)

Salvatore Ortu

Olbia, Sassari, 07026, Italy

Location

Related Publications (1)

• Burrai F, Ortu S, Marinucci M, De Marinis MG, Piredda M. Effectiveness of Immersive Virtual Reality in People with Cancer Undergoing Antiblastic Therapy: A Randomized Controlled Trial. Semin Oncol Nurs. 2023 Aug;39(4):151470. doi: 10.1016/j.soncn.2023.151470. Epub 2023 Jul 16.

  PMID: 37455151 DERIVED

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Fatigue; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Salvatore Ortu, Dr

  Oncology Unit, Giovanni Paolo II Hospital, Olbia,Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: November 29, 2022
• Study Start: July 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: November 16, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)