跳至主要内容
临床试验/NCT07109050
NCT07109050已完成不适用

The Effectiveness of Virtual Reality Interventions Within Specialist Palliative Care (VR-SPC): A Hermeneutic Single Case Efficacy Design (HSCED) Series

University of Lincoln1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2025年8月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Patient Health Questionnaire (PHQ-4; Kroeneke et al., 2009)

研究概览

简要总结

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.

详细描述

Patients who are accessing palliative care have progressive or terminal illness. Patients may also have co-occurring mental health difficulties or reduced wellbeing. There is emerging evidence for psychological wellbeing benefits of non-pharmacological interventions in palliative care. Also it is important for patient's receiving palliative care to have autonomy, dignity and respect in the care they receive (see Ambitions for Palliative and End of Life Care: A national framework for local action 2021-2026). One way to achieve such ambitions and offer an intervention for wellbeing is that of Virtual Reality (VR), whereby an individual is immersed in a digital world by wearing a headset. Immersive experiences can provide patients with a sense of being somewhere new which they may not be able to physically reach due to a decline in health or mobility inline with their palliative needs (Altman et al., 2024).

This study adopts a hermeneutic single case efficacy design (HSCED)series, which involves creating case studies that track up to 6 participants taking part in a 4-week VR intervention. The intervention offered for the study will be psychologically informed in that VR experiences and purpose for the intervention use will be chosen by the patient inline with their own personally important and meaningful goals. By ensuring that choice of the VR intervention offered will promote self-determination in care (e.g. autonomy and relatedness). While also acknowledging patient companion's experiences if patients choose to use VR jointly with their family member or companion, patient companions would also be interviewed about their experience of using VR.

Mixed-methods data collection will occur including quantitative data (questionnaires, number of sessions, time spent wearing VR) and qualitative data (interviews will occur to understand participant experience of using VR). Overall, this study will add to current literature about the effectiveness of VR for patients in palliative care.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: VR Headset (Device)

结局指标

主要结局

Patient Health Questionnaire (PHQ-4; Kroeneke et al., 2009)

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

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.

• Goal based outcome measures (GBO; Law & Jacob, 2015)

时间窗: Baseline, week 1, week 2, and week 3.

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.

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

时间窗: Week 8 (follow up interview).

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.

The Functional Assessment of Chronic Illness Therapy-Palliative (FACIT-Pal) 14 (FACIT PAL-14; Zeng et al., 2013).

时间窗: Baseline and week 8 (follow up interview).

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.

Edmonton Symptom Assessment Scale (ESAS; Bruera et al., 1991)

时间窗: Baseline and week 8 (follow up interview).

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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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