CClinicalTrials.gg
CompletedNCT04966260Updated Aug 7, 2024

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

An interventional study of Standardized Virtual Reality and Control in End-of-Life, Physical Suffering and Psychological Distress, sponsored by Baycrest. Completed at 1 site in Canada. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Baycrest · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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. Virtual Reality (VR) therapy may help address these challenges and be a valuable addition to the current therapies used in palliative care.

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.

02

Conditions studied

  • End-of-Life
  • Physical Suffering
  • Psychological Distress

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Keywords

  • Palliative Care
  • Symptom management
  • Virtual Reality
03

In context

Death

572 studies on the registry are indexed under Death; 111 are open to participants now.

This study's enrollment of 63 is below the median of 133 across 260 interventional studies indexed under Death.

Browse Death studies →

Lead sponsor

Baycrest is the lead sponsor of 33 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Standardized Virtual Reality

    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.

    Other: Standardized Virtual Reality

  • Experimental
    Personalized Virtual Reality

    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.

    Other: Personalized Virtual Reality

  • Active comparator
    Two-Dimensional Video

    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.

    Other: Control

Interventions

  • OtherStandardized Virtual Reality

    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.

  • OtherControl

    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.

  • OtherPersonalized Virtual Reality

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Pre-intervention, post-intervention (same day immediately after intervention), 2 day follow up, 7 day follow up

  2. 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).

    Time frame: Pre-intervention, post-intervention (same day immediately after intervention), 2 day follow up, 7 day follow up

07

Study locations

1 site
  • Baycrest Health Sciences
    Toronto, Ontario M6A 2E1, Canada
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04966260
Lead sponsor
Baycrest
Responsible party
Ginah Kim (Staff Physician Palliative Care Unit, Baycrest) — Principal investigator
First posted
Jul 19, 2021
Start date
Jun 15, 2021
Primary completion
Feb 7, 2023
Completion
Feb 7, 2023
Last update
Aug 7, 2024

Study contacts

Ginah Kim, MD
principal investigator · Baycrest

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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