End-of-LifeNCT04966260

Virtual Reality Therapy to Improve Physical and Psychological Symptoms and Quality of Life for End-of-life Patients on a Palliative Care Unit

A study testing Standardized Virtual Reality and Personalized Virtual Reality in people with End-of-Life and Physical Suffering, run by Baycrest at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

People with advanced and life-threatening illnesses experience challenges across multiple domains of function including physical, psychological, social, and spiritual. The benefits of non-pharmacological interventions for palliative care patients are well recognized, but are relatively under-utilized. Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: End-of-Life, Physical Suffering, Psychological Distress
What is being tested?: Standardized Virtual Reality and Personalized Virtual Reality
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteCanada
Study dates: 15 Jun 2021to 7 Feb 2023
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 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Admitted to Baycrest PCU
Capable to consent to the study
Able to complete the outcome measures through a telephone interview with a research assistant
Estimated prognosis ≥3 weeks
At least 2 or more ESAS scores of 4 or greater within the week of the intervention
English speaking

Who cannot join

Intractable nausea/vomiting
History of seizures or epilepsy
Vision and/or hearing impairment that cannot be accommodated e.g. pocket talker
Any abnormalities of the head preventing use of the headset
Patients who are too unwell to participate based on the opinion of the clinical team

Trial locations and contacts

1 site in 1 country.

Canada1 site

Baycrest Health Sciences
Toronto, Ontario, M6A 2E1

Other trials in Canada

About this study

Official title: Virtual Reality Therapy to Improve Physical and Psychological Symptoms and Quality of Life for End-of-life Patients on a Palliative Care Unit: a Randomized Controlled Study

VR is a computer generated, three-dimensional environment that individuals can explore and interact with using specialized equipment such as a head-mounted display with internal sensors. VR has been increasingly adapted for applications in healthcare, as a simulation for medical training and an intervention tool to impact pain management, stress and anxiety. VR has the potential to improve both physical and psychological symptoms in patients with terminal illnesses.

The current study is a small randomized controlled trial to understand the impact of VR on physical symptoms, psychological symptoms and quality of life in patients at the end of life. Participants will be randomized to a single comparator session, single session of standard VR, or single session of personalized VR. The comparator arm will consist of participants viewing an ordinary two-dimensional video on an iPad such as a peaceful nature scene. The standard VR arm will consist of participants viewing a "bucket list" experience self-selected from a VR library i.e. an experience the participant desires but has never experienced. The personalized VR arm will consist of participants viewing content that is personally meaningful to them. This content will be obtained through either a) family/friends creating a personalized video (e.g. video footage of their summer cottage) or b) the participant will select an experience from the VR library that is personally meaningful (e.g. visiting their honeymoon destination, exploring their childhood hometown, etc.) if option a) is not possible.

Participants will complete self-report questionnaires about their physical and psychological symptoms and quality of life before and after the intervention (two days and seven days post intervention). Participants will also complete a feedback survey to evaluate their satisfaction with the intervention. Surveys will be administered by the research assistant.

Conditions: End-of-Life, Physical Suffering, Psychological Distress
Being tested: Standardized Virtual Reality, Control, Personalized Virtual Reality
Keywords: Palliative Care, Symptom management, Virtual Reality
Medical subject headings: Death, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standardized Virtual RealityOther
This is a one session intervention, where participants will be asked to wear a VR headset and view a three-dimensional standard VR video. The activity session will be approximately 15 minutes in length. Prior to starting the intervention, the therapeutic recreation staff will explain the activity and familiarize participants with the VR headset.
ControlOther
This is a one session intervention, where participants will be asked to view a two-dimensional video on an iPad. The activity session will be approximately 15 minutes in length. Prior to starting the activity session, the therapeutic recreation staff will explain the activity.
Personalized Virtual RealityOther
This is a one session intervention, where participants will be asked to wear a VR headset and view a three-dimensional personalized VR video. The activity session will be approximately 15 minutes in length. Prior to starting the intervention, the therapeutic recreation staff will explain the activity and familiarize participants with the VR headset.

Study groups in NCT04966260
Study group	Role	What they receive
Standardized Virtual Reality	Experimental	Participants in the standard virtual reality (VR) group will choose from the general library of VR experiences. Participants will be asked to select an experience they desire but have never experienced in person. The session will be facilitated by the therapeutic recreation staff on the unit. Receives: Other: Standardized Virtual Reality
Personalized Virtual Reality	Experimental	There are two types of personalized VR: 1) Family/friends provide personalized content (e.g., life stories, photos, videos) that will be used during the VR session. Family/friends of participants in the personalized VR group will have the opportunity to upload custom photos, videos, life stories or capture their own 360° footage of family events using a GoPro camera that will be loaned to them for the study. This content will be uploaded to a cloud-based portal. 2) If the family/friends of those in the personalized VR arm are unavailable/unable/unwilling to provide personalized content the participant will select a video from the VR library of an experience that is personally memorable to them, such as their childhood hometown, a favourite vacation destination. The session will be facilitated by the therapeutic recreation staff on the unit. Receives: Other: Personalized Virtual Reality
Two-Dimensional Video	Active comparator	Participants in the active comparator group will choose a two-dimensional video such as a mountain view, ocean view or safari. Participants will view the two-dimensional video on an iPad and the session will be facilitated by the therapeutic recreation staff on the unit. Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Edmonton Symptom Assessment Scale (ESAS) Score
The ESAS is a self-report measure used to assist in the assessment of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath (Bruera, Kuehn, Miller, Selmser, \& Macmillan, 1991). The severity of the symptom at the time of the assessment is rated from zero to ten, with zero meaning the symptom is absent and ten meaning worst possible severity. For the purpose of the study the ESAS was modified to include two additional items, headache and dizziness.
Analysis of the ESAS scores across the different time points will help determine whether VR effects are transient (within 24 hours) or sustained (after 2 and 7 days).
Measured: Pre-intervention, post-intervention (same day immediately after intervention), 2 day follow up, 7 day follow up
Change in Missoula-VITAS Quality of Life Index (MVQOLI)
The MVQOLI evaluates subjective quality of life among people living with advanced, life-threatening illness by assessing the domains of symptoms, function, interpersonal, wellbeing, and transcendence (Schwartz, Merriman, Reed, \& Byock, 2005). Each domain includes three Likert-scale evaluation questions.
Analysis of the MVQOLI scores across the different time points will help determine whether VR effects are transient (within 24 hours) or sustained (after 2 and 7 days).
Measured: Pre-intervention, post-intervention (same day immediately after intervention), 2 day follow up, 7 day follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 20217 Feb 2023

First posted19 Jul 2021
Study start15 Jun 2021
Primary completion7 Feb 2023
Study completion7 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for End-of-LifeStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a small randomized controlled trial conducted in a study population of patients admitted to a geriatric palliative care unit. The clinical team will determine if the patient is eligible for the study. Patients and families/friends of patients who are randomized to the personalized VR will be consented over the telephone by the research assistant., Participants will then be randomly assigned into one of the three study arms: comparator, standardized VR or personalized VR, on a 1:1:1 basis using computer-generated random numbers and a block size of 3 without additional stratification.
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04966260
Sponsor's protocol ID: 21-15
Status last verified: Aug 2024
First submitted: 29 Jun 2021
Last updated: 7 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Anderson F, Downing GM, Hill J, Casorso L, Lerch N. Palliative performance scale (PPS): a new tool. J Palliat Care. 1996 Spring;12(1):5-11.
PubMed 8857241
Hui D, Shamieh O, Paiva CE, Perez-Cruz PE, Kwon JH, Muckaden MA, Park M, Yennu S, Kang JH, Bruera E. Minimal clinically important differences in the Edmonton Symptom Assessment Scale in cancer patients: A prospective, multicenter study. Cancer. 2015 Sep 1;121(17):3027-35. doi: 10.1002/cncr.29437. Epub 2015 Jun 8.
PubMed 26059846
Schwartz CE, Merriman MP, Reed G, Byock I. Evaluation of the Missoula-VITAS Quality of Life Index--revised: research tool or clinical tool? J Palliat Med. 2005 Feb;8(1):121-35. doi: 10.1089/jpm.2005.8.121.
PubMed 15662181

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Virtual Reality Therapy to Improve Physical and Psychological Symptoms and Quality of Life for End-of-life Patients on a Palliative Care Unit: a Randomized Controlled Study
ClinicalTrials.gov ID: NCT04966260
Acronym / sponsor ID: 21-15
Conditions: End-of-Life, Physical Suffering, Psychological Distress
Keywords: Palliative Care, Symptom management, Virtual Reality
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: BaycrestUniversity, hospital or other
Study start: 15 Jun 2021 (actual)
Primary completion: 7 Feb 2023 (actual)
Study completion: 7 Feb 2023 (actual)
First posted: 19 Jul 2021 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: This is a small randomized controlled trial conducted in a study population of patients admitted to a geriatric palliative care unit. The clinical team will determine if the patient is eligible for the study. Patients and families/friends of patients who are randomized to the personalized VR will be consented over the telephone by the research assistant., Participants will then be randomly assigned into one of the three study arms: comparator, standardized VR or personalized VR, on a 1:1:1 basis using computer-generated random numbers and a block size of 3 without additional stratification.

Arm	Type	Receives
Standardized Virtual Reality	Experimental	Other: Standardized Virtual RealityParticipants in the standard virtual reality (VR) group will choose from the general library of VR experiences. Participants will be asked to select an experience they desire but have never experienced in person. The session will be facilitated by the therapeutic recreation staff on the unit.
Personalized Virtual Reality	Experimental	Other: Personalized Virtual RealityThere are two types of personalized VR: 1) Family/friends provide personalized content (e.g., life stories, photos, videos) that will be used during the VR session. Family/friends of participants in the personalized VR group will have the opportunity to upload custom photos, videos, life stories or capture their own 360° footage of family events using a GoPro camera that will be loaned to them for the study. This content will be uploaded to a cloud-based portal. 2) If the family/friends of those in the personalized VR arm are unavailable/unable/unwilling to provide personalized content the participant will select a video from the VR library of an experience that is personally memorable to them, such as their childhood hometown, a favourite vacation destination. The session will be facilitated by the therapeutic recreation staff on the unit.
Two-Dimensional Video	Active comparator	Other: ControlParticipants in the active comparator group will choose a two-dimensional video such as a mountain view, ocean view or safari. Participants will view the two-dimensional video on an iPad and the session will be facilitated by the therapeutic recreation staff on the unit.

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Admitted to Baycrest PCU
Capable to consent to the study
Able to complete the outcome measures through a telephone interview with a research assistant
Estimated prognosis ≥3 weeks
At least 2 or more ESAS scores of 4 or greater within the week of the intervention

Key exclusion criteria (5 listed)

Intractable nausea/vomiting
History of seizures or epilepsy
Vision and/or hearing impairment that cannot be accommodated e.g. pocket talker
Any abnormalities of the head preventing use of the headset
Patients who are too unwell to participate based on the opinion of the clinical team

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
Standardized Virtual RealityThis is a one session intervention, where participants will be asked to wear a VR headset and view a three-dimensional standard VR video. The activity session will be approximately 15 minutes in length. Prior to starting the intervention, the therapeutic recreation staff will explain the activity and familiarize participants with the VR headset.	Other	Standardized Virtual Reality
ControlThis is a one session intervention, where participants will be asked to view a two-dimensional video on an iPad. The activity session will be approximately 15 minutes in length. Prior to starting the activity session, the therapeutic recreation staff will explain the activity.	Other	Two-Dimensional Video
Personalized Virtual RealityThis is a one session intervention, where participants will be asked to wear a VR headset and view a three-dimensional personalized VR video. The activity session will be approximately 15 minutes in length. Prior to starting the intervention, the therapeutic recreation staff will explain the activity and familiarize participants with the VR headset.	Other	Personalized Virtual Reality

Primary outcome

Change in Edmonton Symptom Assessment Scale (ESAS) Score
Time frame: Pre-intervention, post-intervention (same day immediately after intervention), 2 day follow up, 7 day follow up
The ESAS is a self-report measure used to assist in the assessment of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath (Bruera, Kuehn, Miller, Selmser, \& Macmillan, 1991). The severity of the symptom at the time of the assessment is rated from zero to ten, with zero meaning the symptom is absent and ten meaning worst possible severity. For the purpose of the study the ESAS was modified to include two additional items, headache and dizziness. Analysis of the ESAS scores across the different time points will help determine whether VR effects are transient (within 24 hours) or sustained (after 2 and 7 days).
Change in Missoula-VITAS Quality of Life Index (MVQOLI)
Time frame: Pre-intervention, post-intervention (same day immediately after intervention), 2 day follow up, 7 day follow up
The MVQOLI evaluates subjective quality of life among people living with advanced, life-threatening illness by assessing the domains of symptoms, function, interpersonal, wellbeing, and transcendence (Schwartz, Merriman, Reed, \& Byock, 2005). Each domain includes three Likert-scale evaluation questions. Analysis of the MVQOLI scores across the different time points will help determine whether VR effects are transient (within 24 hours) or sustained (after 2 and 7 days).

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 7 Aug 2024.
Background: PubMed 8857241Anderson F, Downing GM, Hill J, Casorso L, Lerch N. Palliative performance scale (PPS): a new tool. J Palliat Care. 1996 Spring;12(1):5-11.
Background: PubMed 26059846Hui D, Shamieh O, Paiva CE, Perez-Cruz PE, Kwon JH, Muckaden MA, Park M, Yennu S, Kang JH, Bruera E. Minimal clinically important differences in the Edmonton Symptom Assessment Scale in cancer patients: A prospective, multicenter study. Cancer. 2015 Sep 1;121(17):3027-35. doi: 10.1002/cncr.29437. Epub 2015 Jun 8.
Background: PubMed 15662181Schwartz CE, Merriman MP, Reed G, Byock I. Evaluation of the Missoula-VITAS Quality of Life Index--revised: research tool or clinical tool? J Palliat Med. 2005 Feb;8(1):121-35. doi: 10.1089/jpm.2005.8.121.
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.

Ginah Kim, MD principal investigator

Baycrest

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Standardized Virtual Reality and Personalized Virtual Reality in people with End-of-Life and Physical Suffering, run by Baycrest at 1 site in Canada.

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 5 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 7 Aug 2024. 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 Canada. 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 in Edmonton Symptom Assessment Scale (ESAS) Score (time frame: Pre-intervention, post-intervention (same day immediately after intervention), 2 day follow up, 7 day follow up). The study lists 2 primary outcomes in all. 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 NCT04966260, which also lists 3 linked publications.

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 7 Aug 2024.