Tandem VR: Synchronized Nature-Based Experiences in Virtual Reality for Hospice Patients and Their Caregivers

NCT06186960 | Completed Results DMC FDA Device

• 1 other identifier: 2079177-3
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Nature-based virtual reality (VR) and other outdoor experiences in head-mounted displays (HMDs) offer powerful, non-pharmacological tools for hospice teams to help patients undergoing end-of-life (EOL) transitions. However, the psychological distress of the patient-caregiver dyad is interconnected and highlights the interdependence and responsiveness to distress as a unit. Hospice care services and healthcare need strategies to help patients and informal caregivers with EOL transitions.

Conditions

Hospice; End of Life; Palliative Care; Pain; Anxiety; Fear of Death

Keywords

hospice; palliative care; virtual reality; VR; quality of life; personalized; nature; tandem

Outcome Measures

Primary Outcomes (5)

• Quality of Life Domains

  Quality of life will be measured with the McGill Quality of Life Questionnaire (MQOL-E). This assesses eight important life domains: cognition, healthcare, environment, feeling like a burden, and their relationships with physical, psychological, social, and existential/spiritual domains. The 16-item questionnaire uses a 0-10 response scale with a higher score indicating a higher quality of life.

  15 minutes

• Fear of Death

  The Collett-Lester Fear of Death Scale (CL-FODS), measures changes in perception of fear of death and 28 items. The CL-FODS uses a 5-Likert scale ranging from 1= not to 5=very for how disturbed or made anxious a person is by different aspects of death and dying. A higher score indicates a higher fear of death. Some example items include rating how disturbed or made anxious you are about the shortness of life, the lack of control over dying, and feeling lonely without your person. The CL-FODS has four subsections: Death of Self, Death of Others, Dying of Self, and Dying of Others. The means of each subsection and then the total scale scores illustrate the degree of anxiety about death and dying, with a higher value indicating the severity of anxiety about death and dying.

  15 minutes

• Perception of Pain

  Wisconsin Brief Pain Scale Questionnaire will assess perception of pain. Patients will rate their pain from 0=no pain to 10=worst pain imaginable in response to items such as "average pain," "worst pain," "least pain" over the last seven days, and "pain right now." An average of the responses to these items is used to create a single pain severity score. A higher score indicates more perceptions of pain.

  15 minutes

• Acceptance of Tandem VR

  Determine the acceptance of personalized nature-based Tandem VR experiences by dyads as a non-pharmacological modality for addressing the needs of dyads. Acceptance is quantified by the number of dyads accepting or declining the VR experience during recruitment.

  1 minute

• Perceived Benefits and Value of Tandem VR

  Semi-structured interview data will be gathered and examined using a thematic analysis to capture the perceived benefits and value of Tandem VR.

  20 minutes

Study Arms (1)

Tandem Virtual Reality Experience

EXPERIMENTAL

Tandem VR Intervention After the surveys are completed, the researchers will share a personalized library of immersive, nature-based, 360-degree VR experiences for the participant-caregiver dyads to choose from based on their VR Intake Form. Once the dyad has determined their desired Tandem VR experience from the library, the researchers will assist the dyads in donning the VR head mounted display (HMD). The researchers will ensure the safety of both dyads while using the HMDs. The researchers will then initiate the Tandem VR experience. The duration of the Tandem VR experience will be 5-15 minutes.

Device: Tandem Virtual Reality

Interventions

Tandem Virtual Reality DEVICE

Hospice patients and their primary caregiver will each wear virtual reality headsets and will experience a customized and synchronized 5-15min virtual reality experience.

Tandem Virtual Reality Experience

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• Projected life expectancy of \<6 months (established by hospice experts)
• Cognitively intact (has sufficient judgment, planning, organization, and self-control)

You may not qualify if:

• Having a cognitive impairment that affects protocol participation. This will be done with the assistance of Research Recruiters to assess eligibility.
• Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset
• Have a prognosis of hours or actively dying at the time enrollment
• Patients with motion sickness
• Patients with claustrophobia
• Patients with visual and hearing impairment
• Patients with inability to speak English

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• Clemson University: collaborator

Study Sites (1)

Cottingham Hospice House

Seneca, South Carolina, 29672, United States

Location

Related Publications (1)

• McAnirlin O, Thrift J, Li F, Pope JK, Browning MHEM, Moutogiannis PP, Thomas G, Farrell E, Evatt MM, Fasolino T. The Tandem VR protocol: Synchronized nature-based and other outdoor experiences in virtual reality for hospice patients and their caregivers. Contemp Clin Trials Commun. 2024 Jun 22;40:101318. doi: 10.1016/j.conctc.2024.101318. eCollection 2024 Aug.

  PMID: 39045392 DERIVED

MeSH Terms

Conditions

Death; Pain; Anxiety Disorders; Necrophobia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Limitations and Caveats

Limitations of the study: * small sample size * differences in how pre/post questionnaires were administered * decision made to reduce the burden on patients, could have led to different responses * the questionnaire used to measure wellbeing asked respondents to consider their burdens over last 2 days * unable to determine highest influence questions from wellbeing questionnaire * multiple experiences not performed, was not repeated

Results Point of Contact

• Title: Jason Thrift, Assistant Professor
• Organization: Clemson University

jasont@clemson.edu

8649408536

Study Officials

• Joshua K Pope

  Prisma Health Hospice of the Foothills

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multiple Method Design

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: January 2, 2024
• Study Start: March 1, 2024
• Primary Completion: November 20, 2024
• Study Completion: April 30, 2025
• Last Updated: March 13, 2026
• Results First Posted: March 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)