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

Psychological Distress Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04966260
• Other study ID #: 21-15
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: September 2022

Study information

• Verified date: July 2021
• Source: Baycrest
• Contact: Ginah Kim, MD
• Phone: 4167852500
• Email: gkim[@]baycrest.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: September 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Death
• End-of-Life
• Pain
• Physical Suffering
• Psychological Distress
• Stress, Psychological

Intervention

Other:
• Standardized 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.
• Control
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 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.

Locations

Country	Name	City	State
Canada	Baycrest Health Sciences	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Baycrest

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Pre-intervention, post-intervention, 2 day follow up, 7 day follow up
Primary	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).	Pre-intervention, post-intervention, 2 day follow up, 7 day follow up