NCT07109050

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

August 13, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

July 21, 2025

Last Update Submit

September 8, 2025

Conditions

Keywords

virtual realitypalliative care

Outcome Measures

Primary Outcomes (5)

  • 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.

    Baseline, week 1, week 2, week 3, and at week 8 (follow up interview).

  • 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.

    Baseline and week 8 (follow up interview).

  • 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.

    Baseline and week 8 (follow up interview).

  • • 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.

    Baseline, week 1, week 2, and week 3.

  • Change interview procedure based on the 'Change interview' (Elliot et al., 1999)

    Interview to understand individual changes since VR intervention, as well as helpful and unhelpful aspects of an intervention, what has brought change. To be used as a guide and to inspire interviewer prompts.

    Week 8 (follow up interview).

Secondary Outcomes (2)

  • Non validated - Rating scale to assess subjective ratings of VR experience

    Week 1, week 2, and week 3.

  • Helpful Aspects of Therapy (HAT; Llewelyn, 1988)

    Week 1, week 2, and week 3.

Study Arms (1)

Intervention - VR

OTHER

Participants will be offered a VR intervention, whereby they will decide what VR experience they would like to use, picked from a pre-set list. VR experiences will be picked inline with pre-determined goals set by participants in the initial session of the study. VR expereinces range from ocean views, city experiences, to animals.

Device: VR Headset

Interventions

VR 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.

Also known as: VR
Intervention - VR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants recieving palliative care must be:
  • 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.
  • Participant companions (carers, relatives) must be:
  • Aged 18 or over (no upper age limit).
  • Willing and able to engage in VR interventions and travel to the designated hospice site.
  • Able to consent to the research, as assessed by the clinical psychologist supporting recruitment and the primary researcher delivering the VR intervention.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lincoln

Lincoln, United Kingdom

RECRUITING

Central Study Contacts

Nima Professor Moghaddam

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 21, 2025

First Posted

August 7, 2025

Study Start

August 13, 2025

Primary Completion

December 31, 2025

Study Completion

February 28, 2026

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

To protect participant confidentiality due to sensitive nature of the palliative care setting.

Locations