Personalized Virtual Reality Naturalistic Scenarios Promoting Engagement and Relaxation in Patients With Cognitive Impairment: a Proof-of-concept Mixed-methods Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 3
- 主要终点
- VR experience tolerability estimated based on the frequency of time spent in the VR context.
研究概览
简要总结
The goal of this feasibility study is to investigate the feasibility of a personalized naturalistic Virtual Reality scenario by assessing motion-sickness effects, engagement, pleasantness, and emotions felt considering a sample of individuals with cognitive impairment resident at the Azienda Pubblica di Servizi alla Persona (APSP) "Margherita Grazioli", a long-term care home in Trento (Italy) in collaboration with the Department of General Psychology - University of Padova (Italy) and the Centre for Health and Wellbeing-Fondazione Bruno Kessler (Italy). The current proof-of-concept and feasibility study is a one-session single-centre trial based on a mixed-methods approach inspired by the Obesity-Related Behavioral Intervention Trials (ORBIT) framework for the design (Phase Ib) of digital interventions and their preliminary testing (Phase IIa).
详细描述
The impact of customizing VR scenarios is growing, showing different kinds of positive effects, such as an increased sense of presence and engagement in the virtual environment. A relaxing and customizable VR environment could allow the management of any interfering environmental factors that might also be present in the natural context. Additional investigations are still needed to obtain more consistent data on its feasibility and effectiveness.
Considering this evidence, the current proof-of-concept study is based on the following goals:
- evaluate the impact of VR on self-reported and observational levels of motion-sickness, engagement, and pleasantness in older adults living with cognitive impairment and residing in long-term care.
- investigate if personalized, relaxing virtual environments can positively impact feelings and state anxiety.
- investigate the VR apparatus's usability from the health staff's perspective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Italian mother tongue
- •Clinical diagnosis of Cognitive Impairment (mild, moderate, or severe).
排除标准
- •Palliative care
- •Clinical diagnosis of psychosis
- •Severe neurological damage
- •A clinical diagnosis of epilepsy (or having first-degree relatives diagnosed with epilepsy) - - Cardiac pacemaker or other metal devices
- •Infectious or gastrointestinal disorders
- •Open wounds at the level of the face
- •Motor or visual dysfunctions and neuromuscular pain that prevent the use of Oculus.
结局指标
主要结局
VR experience tolerability estimated based on the frequency of time spent in the VR context.
时间窗: Through study completion, an average of 6 months
The VR experience tolerability was estimated based on the frequency of time spent in the VR context.
Assessing the general and eye-related physical symptoms of exposure to a virtual reality environment.
时间窗: Through study completion, an average of 6 months
To assess these symptoms, the Virtual Reality Symptom Questionnaire (VRSQ) was used. The score assigned to each item ranges from 0 to 6, with a maximum total score of 84 (48 for general symptoms and 36 for eye symptoms). Higher scores represent worse symptoms, with 0 corresponding to no adverse effects, and 84 to serious adverse effects.
Usability of the VR apparatus
时间窗: Through study completion, an average of 6 months
The usability has been investigated by a measure developed and described by Appel et al. (2020) composed of both self-reported questions and other queries that the experimenter answered by observing the participant's behavior during the experience and characterized by a series of items based on a 5 points Likert scale (Questions about Level of interest, awareness, engagement, and enjoyment observed: 1="very much", 5="not at all"; min. score=5 and max. score=25; higher scores mean a worse outcome. Questions on other information in relation to the VR experience: 1= "strongly disagree", 5= "strongly agree"; min. score=17 and max. score=85; higher scores mean a better outcome), and six open-ended questions focalized in obtaining additional information, where possible, about: 1) what participants liked best and least; 2) what participants would like to see; 3) if participants would like to repeat the experience; 4) if participants would recommend the experience to a friend.
次要结局
- Feedback about the perceived quality rating of the VR set-up deployed from health care staff(Through study completion, an average of 6 months)
- Change from before and after the one-shot VR session in the relaxation using the modified version of the State-Trait Anxiety Inventory-Y1 (STAI-Y1).(Through study completion, an average of 6 months)
- Feedback about usability from health care staff(Through study completion, an average of 6 months)
- Feedback about acceptability from health care staff(Through study completion, an average of 6 months)
- Change from before and after the one-shot VR session in emotions felt using the Observed Emotion Rating Scale (OERS).(Through study completion, an average of 6 months)
研究者
Caterina Novara
Associate Professor
University of Padova