An interventional study of Tandem Virtual Reality in Hospice, End of Life and Palliative Care, sponsored by Prisma Health-Upstate. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Prisma Health-Upstate · Not applicable, Interventional, and Treatment
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.
Methods: This study uses a synchronized Tandem VR approach where patient- caregiver dyads experience immersive nature-based and other outdoor VR content. This mixed methods study will recruit 20 patient-caregiver dyads (N = 40) enrolled in home hospice services nearing the end-of-life. Dyads will experience a personalized nature-based or other outdoor VR experience lasting 5-15 minutes. Self-reported questionnaires and semi-structured interviews will be collected before and after the VR intervention to identify the impacts of personalized nature-based and other outdoor Tandem VR experiences on the QOL, pain, and fear of death in patient-caregiver dyads enrolled with hospice services. Additionally, this protocol will determine the acceptance of personalized nature-based and other outdoor Tandem VR experiences by dyads as a non-pharmacological modality for addressing patient and caregiver needs. Acceptance was quantified by the number of dyads accepting or declining the VR experience during recruitment.
Discussion: Using personalized, nature-based and other outdoor VR experiences, the patient-caregiver dyads can simultaneously engage in an immersive encounter to help alleviate symptoms associated with declining health and EOL phases for the patient and the often overburdened caregiver. This protocol focuses on meeting the need for person- and caregiver-centered, non-pharmacological interventions to reduce physical, psychological, and spiritual distress.
Exclusion criteria:
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
Hospice patients and their primary caregiver will each wear virtual reality headsets and will experience a customized and synchronized 5-15min virtual reality experience.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 20 minutes
Recruitment began February 1, 2024, and concluded November 20, 2024. Recruitment began in the clinic setting, using the Uptake Form to assess the patient and informal caregiver interest in the VR intervention for deployment in the home environment.
| Milestone | Tandem Virtual Reality Experience for Patients | Tandem Virtual Reality Experience for Informal Caregivers |
|---|---|---|
| Started | 13 | 13 |
| Completed | 11 | 11 |
| Not completed | 2 | 2 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
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.
| units on a scale | Quality of Life-Patients | Quality of Life-Informal Caregivers |
|---|---|---|
| Quality of Life Domains | 1.68 ± 3.66 | 1.27 ± 1.90 |
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.
| units on a scale | Fear of Their Own Death-Patient | Fear of Dying Process-Patients | Fear of Another Person's Death-Patients | Fear of Another Person's Dying Process-Patients | Fear of Their Own Death-Informal Caregivers | Fear of Dying Process-Informal Caregivers | Fear of Another Person's Death-Informal Cargivers | Fear of Another Person's Dying Process-Informal Caregivers |
|---|---|---|---|---|---|---|---|---|
| Fear of Death | -0.04 ± 0.24 | 0.50 ± 0.96 | -0.31 ± 1.18 | -0.11 ± 1.75 | 0.00 ± 0.33 | 0.50 ± 0.40 | -0.51 ± 0.64 | -0.23 ± 0.61 |
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.
| units on a scale | Perception of Pain-Patient | Perception of Pain-Informal Caregivers |
|---|---|---|
| Perception of Pain | -0.64 ± 1.43 | -0.18 ± 1.66 |
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.
| Participants | Acceptance of Tandem VR Intervention |
|---|---|
| Acceptance of Tandem VR | 22 |
Semi-structured interview data will be gathered and examined using a thematic analysis to capture the perceived benefits and value of Tandem VR.
| Participants | Themes and Dyad Perceptions |
|---|---|
| Found Joy | 22 |
| Together Again | 4 |
| Great Experience | 8 |
Collected over From the initiation of the intervention until the intervention was stopped before completion, 10 minutes. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adverse Events During Tandem VR Intervention Reported by Patient | 0/13 (0%) | 0/13 (0%) | 1/13 (7.7%) |
| Adverse Events During Tandem VR Intervention Reported by Informal Caregiver | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Event | Adverse Events During Tandem VR Intervention Reported by Patient | Adverse Events During Tandem VR Intervention Reported by Informal Caregiver |
|---|---|---|
| Dizziness in Tandem VR InterventionSocial circumstances | 1/13 | 0/13 |
11 dyads were subjects in the intervention, 11 patients and 11 informal caregivers for a total of 22 individuals participating.
| Age, Categorical(Participants) | Tandem Virtual Reality Experience for Patients | Tandem Virtual Reality Experience for Informal Caregivers | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 8 | 9 |
| >=65 years | 10 | 3 | 13 |
| Sex: Female, Male(Participants) | Tandem Virtual Reality Experience for Patients | Tandem Virtual Reality Experience for Informal Caregivers | Total |
|---|---|---|---|
| Female | 7 | 9 | 16 |
| Male | 4 | 2 | 6 |
| Race (NIH/OMB)(Participants) | Tandem Virtual Reality Experience for Patients | Tandem Virtual Reality Experience for Informal Caregivers | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 10 | 10 | 20 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Tandem Virtual Reality Experience for Patients | Tandem Virtual Reality Experience for Informal Caregivers | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 11 | 11 | 22 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Tandem Virtual Reality Experience for Patients | Tandem Virtual Reality Experience for Informal Caregivers | Total |
|---|---|---|---|
| United States | 11 | 11 | 22 |
| Virtual Reality Content(Participants) | Tandem Virtual Reality Experience for Patients | Tandem Virtual Reality Experience for Informal Caregivers | Total |
|---|---|---|---|
| Past Home Videos | 5 | 5 | 10 |
| Bucket List Destinations | 6 | 6 | 12 |
| Bucket List Experiences | 6 | 6 | 12 |
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