VR for Symptom Control and Wellbeing

Sponsor

Royal Cornwall Hospitals Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT04821466

Collaborator

(none)

Enrollment

Location

Arm

21.7

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate the effect that a Virtual Reality experience can have on patient symptoms and wellbeing for palliative care and oncology inpatients

Condition or Disease	Intervention/Treatment	Phase
Oncology End Stage Cancer Palliative Care Hematologic Malignancy	Device: Virtual Reality Headset to provide a Virtual Reality Experience	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Cohort interrupted time series studyCohort interrupted time series study

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Use of Virtual Reality for Symptom Control and Wellbeing in Palliative Care and Oncology Patients

Actual Study Start Date :

Jun 14, 2021

Anticipated Primary Completion Date :

Apr 4, 2023

Anticipated Study Completion Date :

Apr 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual Reality Headset VR headset, programmed with a selection of 7 wellbeing programs to identify if use will improve participants wellbeing	Device: Virtual Reality Headset to provide a Virtual Reality Experience Participants will utilise a Virtual Reality experience for distraction therapy via a Virtual reality headset. Participants will wear the Virtual reality headset to be immersed in a multimedia experience.

Arm

Intervention/Treatment

Experimental: Virtual Reality Headset

VR headset, programmed with a selection of 7 wellbeing programs to identify if use will improve participants wellbeing

Device: Virtual Reality Headset to provide a Virtual Reality Experience

Participants will utilise a Virtual Reality experience for distraction therapy via a Virtual reality headset. Participants will wear the Virtual reality headset to be immersed in a multimedia experience.

Outcome Measures

Primary Outcome Measures

ESAS-r Quality of Life Scores [Time 0 & Time 60 minutes]
Change in ESAS-r QoL score between start and finish of Virtual Reality experience. 0 = No symptoms to 10 = Worst Symptom

Secondary Outcome Measures

Quantitative clinician experience of VR intervention [Time 60 minutes]
Clinician score of patient experience using Virtual Reality intervention for symptoms and wellbeing between 0 (negative) and 10 (positive)
Quantitative clinician experience of VR intervention [Time 60 minutes]
Patient score of experience using Virtual Reality intervention for symptoms and wellbeing between 0 (negative) and 10 (positive)

Other Outcome Measures

Qualitative patient experience of VR interventions [Time 60 minutes]
Patients to answer: Were there any negative side effects of the VR session?
Repeat VR experiences [12 Months]
ESAS-r QoL Scores (0 to 10) will be collected each time a patient uses the experience to consider the effect repeat exposure has on wellbeing and symptoms. 0 = No symptoms to 10 = Worst Symptom

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria

18 years of age
Inpatient at RCHT know to the palliative care team
Able to consent
Able to speak and understand the English language
Able to use the virtual reality system
Able to complete ESAS-r Questionnaire

Exclusion criteria

<18 years of age
Patient unable to consent
Patient unable to speak English
Unable to use the virtual reality system (e.g. visually impaired)
Known Epilepsy or seizures or suspected predisposition to seizures (e.g. Brain metastasis)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Cornwall Hospital	Truro	Cornwall	United Kingdom	TR1 3HD

Sponsors and Collaborators

Royal Cornwall Hospitals Trust

Investigators

Principal Investigator: Niall O Moon, BMBCh, Doctor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Royal Cornwall Hospitals Trust

ClinicalTrials.gov Identifier:

NCT04821466

Other Study ID Numbers:

2021.RCHT.07

First Posted:

Mar 29, 2021

Last Update Posted:

Aug 2, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Royal Cornwall Hospitals Trust

Virtual Reality

Additional relevant MeSH terms:

Neoplasms

Hematologic Neoplasms

Study Results

No Results Posted as of Aug 2, 2022