NCT06149429

Brief Summary

The purpose of this research is to determine the effect that repeated, personalized virtual reality experiences have on symptom severity, comparing self-reported symptom severity both pre and post each session, and overtime across sessions. Researchers will also determine if this intervention results in a high rating of presence in VR, and if presence is related to the magnitude of the change in symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 29, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

November 20, 2023

Last Update Submit

December 16, 2024

Conditions

Keywords

HospiceSerious IllnessVirtual realityEnd-of-life

Outcome Measures

Primary Outcomes (1)

  • Edmonton Symptom Assessment System - Revised (ESAS)

    End-of-life symptom assessment

    Two weeks

Secondary Outcomes (1)

  • igroup presence questionnaire (IPQ)

    Two weeks

Study Arms (1)

Single-Arm Open Pilot

EXPERIMENTAL

Pre- Post-intervention design. The intervention that participants will be experiencing is personalized virtual reality experiences. The content of this experience will be determined at the initial visit during which the participant will complete a preference questionnaire which identifies the location they want to "go" to. These experiences will be filmed on the insta360 One R camera by the research coordinator. Each experience will be approximately 20 minutes. To view the videos participants will wear the Oculus Quest 2 virtual reality headset.

Behavioral: Personalized virtual reality experience

Interventions

The intervention that participants will be experiencing is personalized virtual reality experiences. The content of this experience will be determined at the initial visit during which the participant will complete a preference questionnaire which identifies the location they want to "go" to. These experiences will be filmed on the insta360 One R camera by the research coordinator. Each experience will be approximately 20 minutes. To view the videos participants will wear the Oculus Quest 2 virtual reality headset.

Single-Arm Open Pilot

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are hospice care eligible as defined by the Medicare Hospice benefit and receive hospice or palliative care from Hospice and Palliative Care Buffalo.

You may not qualify if:

  • Their Palliative Performance Score (PPS) is below 30.
  • They are not cognitively intact (display symptoms of delirium or senility, or have a cognitive diagnosis such as Alzheimer's or Dementia) as measured by the Confusion Assessment Method (CAM) (Inouye et al., 1990)
  • They have hearing, vision, or speech impairments that are uncorrected.
  • They have current symptoms of or a history of dizziness, nausea, headaches, migraines, seizures, or motion sickness.
  • They do not speak English.
  • They are not 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospice and Palliative Care Buffalo

Cheektowaga, New York, 14225, United States

Location

MeSH Terms

Conditions

DeathPainNauseaFatiguePsychological Well-BeingDepressionDyspneaAnorexiaAnxiety Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsSigns and Symptoms, DigestivePersonal SatisfactionBehaviorBehavioral SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratoryMental Disorders

Study Officials

  • Catherine Mann, EdD

    SUNY Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single group open pilot, pre- post-intervention study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 29, 2023

Study Start

October 23, 2023

Primary Completion

July 15, 2024

Study Completion

July 15, 2024

Last Updated

December 19, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Due to the sensitive nature of the study population at end-of-life and small sample size we feel that it poses undue risk for harm due to potential for anonymity being compromised.

Locations