Virtual Reality Within Palliative Care (VR-SPC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Lincoln
About this trial
Literature so far shows VR is largely acceptable and feasible to use in palliative care settings, especially for improving patient wellbeing and mental health. However, limited research exists for understanding the effectiveness of VR, especially if sessions are repeated or offered jointly with patient carers or companions. We aim to investigate the effectiveness of VR for achieving personally meaningful goals (including but not limited to relaxation, bucket-list activities, and improving wellbeing). This study will be offered to patients and their companions receiving palliative care at a hospice in England. Informed consent will be acquired after a participant information sheet has been shared with interested participants. Personal goals of VR use will be established at the start of the study with baseline mental health and wellbeing data collection. Up to 3 VR sessions will be offered.
Before and after each session patients will be asked to complete questionnaires to track wellbeing and progression towards intended goals for utilising VR. A change interview will occur between 1 to 4 weeks after the final VR session to discuss their overall experiences of VR and will include repeated follow up questionnaires. Participants that which to engage with a joint-VR intervention with their companion (referred to as participant companions for the purposes of this study), will also require informed consent and completion of questionnaires and interview attendance to be involved with this study.
Results will be gathered and analysed by creating anonymous individual rich case records and shared with a panel of independent psychologists to conclude whether or not, from our findings, virtual reality is effective for achieving personally important goals. Findings will be shared with the hospice involved and form a Doctoral Thesis based at the University of Lincoln.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18 or over (no upper age limit due to the service being lifelong).
Patients deemed to be palliative, receiving specialist care at the designated hospice as either an inpatient or outpatient.
Willing and able to engage in VR interventions as determined by the patients' usual care team.
Able to consent to the research, as assessed by the clinical psychologist supporting recruitment and the primary researcher delivering the VR intervention.
Disqualifiers
Lacking capacity to consent to take part in research as assessed by both the clinical psychologist supporting recruitment and the primary researcher delivering VR.
Exhibiting contraindications as set out by care team including eyesight impairments or neurological conditions such as epilepsy or dementia.
Trial design
Design model
Single group
Treatments tested in this trial
VR Headset
DeviceVR will be offered on either an individual or joint-experience basis, whereby the participant(s) wear a VR headset with 360 degree views, to explore various VR experiences of their choice for up to 3 sessions on a weekly basis. Goals for using VR will be ascertained by completing the goal based measure with the patient who is accessing specialist palliative care. This will define the purpose of the VR intervention in future sessions. The participant will be shown a list of VR experience options so they are aware of these prior to the next session. Pre-VR and post-VR questionnaires will be completed.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Intervention - VROther 1 intervention
Trial outcomes
Primary outcomes
1
Patient Health Questionnaire (PHQ-4; Kroeneke et al., 2009)
Depression and anxiety measure. 4 items. 4-point Likert Scale (0 = Not at all, 3 = Nearly every day). Wording of the question and options will be adapted for post-VR use to include 'how much are you feeling bothered by the following problems now?' along with options changed to 'not at all', 'a little bit', 'somewhat', 'a lot'. Higher scores indicate higher likelihood of depression and anxiety, whereby: * None = 0-2 * Mild = 3-5 * Moderate = 6-8 * Severe = 9-12 On each subscale, a score of 3 or greater is considered positive for screening purposes.
Time frame
Baseline, week 1, week 2, week 3, and at week 8 (follow up interview).2
The Functional Assessment of Chronic Illness Therapy-Palliative (FACIT-Pal) 14 (FACIT PAL-14; Zeng et al., 2013).
Quality of life measure for palliative care patients. 14 items. 5-point Likert Scale (0 = Not at all, 5 = Very much). Higher score indicates a better quality of life.
Time frame
Baseline and week 8 (follow up interview).3
Edmonton Symptom Assessment Scale (ESAS; Bruera et al., 1991)
Assesses pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. 10 items. Each symptom is rated on a scale of 0 (no symptom) to 10 (worst possible symptom). Higher scores indicate higher incidents and severity of symptoms.
Time frame
Baseline and week 8 (follow up interview).4
• Goal based outcome measures (GBO; Law & Jacob, 2015)
To set individual goals for interventions and track progress. Up to 3 goals set, and tracking on a scale from 0 to 10 how much an individual feels they are achieving their goal. Progress is monitored overtime.
Time frame
Baseline, week 1, week 2, and week 3.Secondary outcomes
1
Non validated - Rating scale to assess subjective ratings of VR experience
How immersed into the VR experience did you feel on a scale of 1 to 10 where 0 = not immersed at all, 10 = fully immersed? The wording of this question may differ depending on the VR experience selected, such as "how much did you feel like you were swimming with the dolphins, with 1 being not at all, and 10 being like you were right there with the dolphins?" to aid understanding of the question
Time frame
Week 1, week 2, and week 3.2
Helpful Aspects of Therapy (HAT; Llewelyn, 1988)
To understand helpful and unhelpful aspects of an intervention. 7 items. Open-ended questions whereby participants describe in their own words the most helpful and unhelpful aspects of the session. Wording will be adapted for the purposes of this study to apply to VR sessions as opposed to 'therapy'.
Time frame
Week 1, week 2, and week 3.Sponsors and contacts
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Source ClinicalTrials.gov