Evaluating the Impact of VR-therapy on BPSD and QoL of Individuals With Dementia Admitted to Hospital
NCT ID: NCT03941119
Last Updated: 2020-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
77 participants
INTERVENTIONAL
2019-05-06
2020-03-16
Brief Summary
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The objectives of this RCT are 1) to evaluate the effects of VR-therapy on BPSD and the hospital care experience of in-patients with dementia and/or delirium admitted to an acute care hospital, 2) to determine the usability, tolerability, and safety of VR-therapy for patients with dementia and/or delirium admitted to acute care, 3) determine the effect of VR-therapy on quality of life for patients with dementia and/or delirium admitted to acute care and 4) to explore a framework for introducing non-pharmacological therapies in acute care hospitals.
Our hypotheses are 1) VR-therapy helps manage BPSD (e.g. decrease anxiety, aggression, depression, violent behaviors, incidents of wandering), and may decrease the amount and/or frequency of sedatives and anti-depressant medication administered and/or the number of incidents that require restraints, and the number of falls, in people with dementia and/or delirium admitted to an acute care hospital. 2) VR-therapy will improve the quality of life for individuals with dementia and/or delirium admitted to an acute care hospital (operationalized through conducting a validated instrument to measure quality of life for people with dementia). 3) VR-therapy is safe and feasible to administer to individuals with dementia and/or delirium admitted to an acute care hospital (with assistance from their circle of care members and/or caregivers).
Detailed Description
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Exposure to natural environments (seeing greenery, hearing outside natural sounds) has been shown to enhance wellbeing, reduce depression, anxiety, and stress levels, and decrease hospital length-of-stay for inpatients. Through VR technology, one's surroundings can be seamlessly replaced by a virtual world of their choosing. Based on previous studies and expert consultation, we created a library of VR experiences depicting calming nature scenes (peaceful lake, refreshing forest, cheerful playground) designed specifically for people with dementia, as a prototype for introducing immersive VR-therapy to hospitals, long term care facilities and private homes. The goal of VR-therapy is to help manage BPSD and stimulate psychological/cognitive health and daytime engagement for people with dementia.
The RCT will be informed by our prior pilot study conducted in the hospitalist medicine department of Michael Garron Hospital with inpatients with dementia to validate the proposed RCT study protocol (processes, methods, recruitment strategy, resource requirements, timelines) as well as by previous feasibility studies in outpatients that showed it is safe and feasible to use VR/HMDs for people with dementia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention
The intervention arm will receive a VR-therapy session every 24-72 hours of their stay in the hospital. Participants will view specially designed 360-degree VR films using a Virtual Reality head mounted display for a maximum of 20 minutes per session.
VR-therapy
Wearing a Virtual Reality head mounted device allows the user to become immersed in a virtual environment. We have assembled a library of 3-10 minute 360-degree films from a variety of nature settings. The VR films were intentionally chosen to be calming in distinctive ways, as supported by the literature around nature visualization and wellbeing. By varying 1) the lengths of the films (3, 5, and 10 minutes), 2) the types of natural elements (greenery, earth, sky, water), 3) distance of view (close-ups, vistas), 4) motion (flowing water, wind in trees), 5) sound, and 6) presence of different elements (humans/animals, scenery, urban sites, etc.), the content provides a wide range of attributes that can be collaboratively selected by the individual, caregiver, or health care provider for each individual. We will display these films on commercially available VR equipment and will provide audio matching the film using commercially available headphones.
Control
The control arm will not receive any VR-therapy sessions during their hospital stay.
No interventions assigned to this group
Interventions
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VR-therapy
Wearing a Virtual Reality head mounted device allows the user to become immersed in a virtual environment. We have assembled a library of 3-10 minute 360-degree films from a variety of nature settings. The VR films were intentionally chosen to be calming in distinctive ways, as supported by the literature around nature visualization and wellbeing. By varying 1) the lengths of the films (3, 5, and 10 minutes), 2) the types of natural elements (greenery, earth, sky, water), 3) distance of view (close-ups, vistas), 4) motion (flowing water, wind in trees), 5) sound, and 6) presence of different elements (humans/animals, scenery, urban sites, etc.), the content provides a wide range of attributes that can be collaboratively selected by the individual, caregiver, or health care provider for each individual. We will display these films on commercially available VR equipment and will provide audio matching the film using commercially available headphones.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients admitted to Michael Garron Hospital (MGH).
* Patients diagnosed with, or suspected to have, dementia.
Exclusion Criteria
* Patients with a history of seizures or epilepsy.
* Patients with a pacemaker.
* Patients with head trauma or stroke leading to their current admission.
* Patients with cervical conditions or injuries that would make it unsafe for them to use the VR headset.
* Patients with alcohol related dementia/ Korsakoff syndrome.
* Patients admitted to the Intensive Care Unit (ICU) or Adult Mental Health Inpatient Service.
* Patients who require but do not have a Substitute Decision Maker (SDM) or patients from which there is no contactable SDM.
* Patients who have a Public Guardian and Trustee (PGT) as SDM.
* Patients who participated in the VRx study during their previous hospitalization and are readmitted less than 30-days after previous hospital discharge.
65 Years
ALL
No
Sponsors
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Centre for Aging and Brain Health Innovation
OTHER
Michael Garron Hospital
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Lora Appel
Collaborating Scientist
Principal Investigators
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Lora Appel, PhD
Role: PRINCIPAL_INVESTIGATOR
OpenLab, University Health Network
Locations
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Michael Garron Hospital
Toronto, Ontario, Canada
Countries
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References
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Berman MG, Kross E, Krpan KM, Askren MK, Burson A, Deldin PJ, Kaplan S, Sherdell L, Gotlib IH, Jonides J. Interacting with nature improves cognition and affect for individuals with depression. J Affect Disord. 2012 Nov;140(3):300-5. doi: 10.1016/j.jad.2012.03.012. Epub 2012 Mar 31.
Brodaty H, Donkin M. Family caregivers of people with dementia. Dialogues Clin Neurosci. 2009;11(2):217-28. doi: 10.31887/DCNS.2009.11.2/hbrodaty.
Diette GB, Lechtzin N, Haponik E, Devrotes A, Rubin HR. Distraction therapy with nature sights and sounds reduces pain during flexible bronchoscopy: a complementary approach to routine analgesia. Chest. 2003 Mar;123(3):941-8. doi: 10.1378/chest.123.3.941.
Hughes JC, Louw SJ. Electronic tagging of people with dementia who wander. BMJ. 2002 Oct 19;325(7369):847-8. doi: 10.1136/bmj.325.7369.847. No abstract available.
Kaplan R. The Nature of the View from Home: Psychological Benefits. Sage Publications 33(4): 507-542, 2001.
Kaplan S. The restorative benefits of nature: toward an integrative framework. Journal of Environmental Psychology 15: 169-182
Morita E, Fukuda S, Nagano J, Hamajima N, Yamamoto H, Iwai Y, Nakashima T, Ohira H, Shirakawa T. Psychological effects of forest environments on healthy adults: Shinrin-yoku (forest-air bathing, walking) as a possible method of stress reduction. Public Health. 2007 Jan;121(1):54-63. doi: 10.1016/j.puhe.2006.05.024. Epub 2006 Oct 20.
Park BJ, Tsunetsugu Y, Kasetani T, Kagawa T, Miyazaki Y. The physiological effects of Shinrin-yoku (taking in the forest atmosphere or forest bathing): evidence from field experiments in 24 forests across Japan. Environ Health Prev Med. 2010 Jan;15(1):18-26. doi: 10.1007/s12199-009-0086-9.
Park SH, Mattson RH. Ornamental indoor plants in hospital rooms enhanced health outcomes of patients recovering from surgery. J Altern Complement Med. 2009 Sep;15(9):975-80. doi: 10.1089/acm.2009.0075.
Robinson L, Hutchings D, Corner L, Beyer F, Dickinson H, Vanoli A, Finch T, Hughes J, Ballard C, May C, Bond J. A systematic literature review of the effectiveness of non-pharmacological interventions to prevent wandering in dementia and evaluation of the ethical implications and acceptability of their use. Health Technol Assess. 2006 Aug;10(26):iii, ix-108. doi: 10.3310/hta10260.
Ulrich RS. View through a window may influence recovery from surgery. Science. 1984 Apr 27;224(4647):420-1. doi: 10.1126/science.6143402.
Ulrich, RS. Natural Versus Urban Scenes: Some Psychophysiological Effects. Environment and Behavior 13(5): 523-556, 1981.
Ulrich RS. Health Benefits of Gardens in Hospitals. Plants for People International Exhibition Floriade 2002.
Ulrich RS, Simons RF, Losito BD, Fiorito E, Miles MA, Zelson M. Stress recovery during exposure to natural and urban environments. Journal of Environmental Psychology 11: 201-230, 1991.
Weiner MF, Martin-Cook K, Svetlik DA, Saine K, Foster B, Fontaine CS. The quality of life in late-stage dementia (QUALID) scale. J Am Med Dir Assoc. 2000 May-Jun;1(3):114-6.
Appel L, Appel E, Kisonas E, Lewis-Fung S, Pardini S, Rosenberg J, Appel J, Smith C. Evaluating the Impact of Virtual Reality on the Behavioral and Psychological Symptoms of Dementia and Quality of Life of Inpatients With Dementia in Acute Care: Randomized Controlled Trial (VRCT). J Med Internet Res. 2024 Jan 30;26:e51758. doi: 10.2196/51758.
Related Links
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Elderly women with dementia view virtual reality films and provide feedback on their experience.
The VRx RCT website offered to participants and/or their substitute decision makers to learn more about VR and the study.
Other Identifiers
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782-1812-Mis-332
Identifier Type: -
Identifier Source: org_study_id