CancerNCT05629507
Effectiveness of Immersive Virtual Reality in Patients With Cancer
A study testing Virtual Reality in people with Cancer and Chemotherapy Effect, run by ASL Gallura - Ospedale Giovanni Paolo II at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chemotherapy Effect, Anxiety
- What is being tested?
- Virtual Reality
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2022to 16 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- use of antipsychotic drugs;
- epilepsy;
- use of drugs or alcohol;
- metastatic cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Cancer, Chemotherapy Effect, Anxiety, Fatigue, Pain
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Cancer, Chemotherapy, Anxiety, Fatigue, Pain
- Medical subject headings
- Neoplasms, Anxiety Disorders, Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, pre-intervention and immediately after the intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Jul 2022
- Primary completion30 Oct 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASL Gallura - Ospedale Giovanni Paolo II
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Ortu, ASL Gallura - Ospedale Giovanni Paolo II
- Investigators
- Salvatore Ortu, Dr, Principal investigator, Oncology Unit, Giovanni Paolo II Hospital, Olbia,Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629507
- Sponsor's protocol ID
- VROM_01
- Status last verified
- Nov 2022
- First submitted
- 4 Oct 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37455151
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Immersive Virtual Reality in Patients With Cancer Undergoing Chemotherapy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05629507
- Acronym / sponsor ID
- VROM_01
- Conditions
- Cancer, Chemotherapy Effect, Anxiety, Fatigue, Pain
- Keywords
- Virtual Reality, Cancer, Chemotherapy, Anxiety, Fatigue, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- ASL Gallura - Ospedale Giovanni Paolo IIUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Virtual RealityIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age> 18 years;
- diagnosis of cancer with indication for intravenous chemotherapy;
- cognitively able to participate;
- no significant acoustic deficit;
- no significant visual impairment;
Key exclusion criteria (4 listed)
- use of antipsychotic drugs;
- epilepsy;
- use of drugs or alcohol;
- metastatic cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityThe 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). | Device | Virtual Reality |
Primary outcome
Change is being assessed for Anxiety
Time frame: Baseline, pre-intervention and immediately after the intervention
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.
4 secondary outcomes
Assessment of Fatigue
Time frame: Baseline, pre-intervention and immediately after the intervention
Assessment of Pain
Time frame: Baseline, pre-intervention and immediately after the intervention
Number of partecipants with Adverse effects
Time frame: Baseline, pre-intervention and immediately after the intervention
Number of partecipants with a therapeutic adherence
Time frame: Baseline, pre-intervention and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Derived from this study: PubMed 37455151Burrai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Ortu, Dr principal investigator
Oncology Unit, Giovanni Paolo II Hospital, Olbia,Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Cancer and Chemotherapy Effect, run by ASL Gallura - Ospedale Giovanni Paolo II at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change is being assessed for Anxiety (time frame: Baseline, pre-intervention and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05629507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.