The Effectiveness of Virtual Environment on the Adverse Psychological Effects in Patients Receiving Treatment for Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in Mood Disturbances as measured by the POMS
研究概览
简要总结
The mood disturbances that lung cancer patients experience during and after chemotherapy have a debilitating effect on their quality of life. The goal of the proposed project is to develop and test an intervention that relies on the use of immersive Virtual Reality (VR) to combat the adverse psychological/emotional consequences of receiving treatment for cancer. Although VR has been used with success to treat various psychological conditions (e.g., phobias, PTSD), its potential in helping cancer patients experience an improved mood and hence better quality of life has not yet been tested. In this project the investigators will first develop the virtual content (e.g., natural scenes) that patients will experience within a Head-Mounted-Display, simulating movement by manipulating a gesture controller. The investigators will then carry out a randomized, double blind, crossover trial with 50 hospitalized cancer patients to test whether they can benefit psychologically and emotionally from their interaction with an immersive environment compared to those who will experience a guided imagery intervention. A positive result will open the route for the future development of affordable self-administered VR solutions for treating the psychological side-effects of cancer treatment.
详细描述
Although VR has been used with success to treat various psychological conditions (e.g., phobias, PTSD), its potential in helping cancer patients experience an improved mood and hence better quality of life has not yet been tested. In this project the investigators will first develop the virtual content (e.g., natural scenes) that patients will experience within a Head-Mounted-Display, simulating movement by manipulating a gesture controller. The investigators will then carry out a randomized, double blind, crossover trial with 50 hospitalized cancer patients to test whether they can benefit psychologically and emotionally from their interaction with an immersive environment compared to those who will experience a guided imagery intervention. A positive result will open the route for the future development of affordable self-administered VR solutions for treating the psychological side-effects of cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included if they had a histopathological diagnosis of cancer (different types are allowed)
- •were 18 years or older, on active treatment and were receiving care at the hospital as inpatients
- •Eligible participants will need to be able to speak and understand Greek and they had given written informed consent
- •Participants should also have a score of >60 on the POMS total mood disturbance scale, a >50 on the Karnofsky Performance Scale Index
- •a mean of >50 on the Attentional Function Index (AFI)
排除标准
- •Patients were excluded if they were receiving palliative care
- •they had an impaired cognitive ability or
- •they had an impaired visual ability
结局指标
主要结局
Changes in Mood Disturbances as measured by the POMS
时间窗: Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days
The POMS total mood disturbance comprises subscales that evaluate anxiety, depression, anger, vigor, fatigue, and confusion. The possible range of scores for the TMDS is -40 through 192 with higher scores indicating greater mood. Lower scores indicate an improvement in mood
次要结局
- Changes in Quality of Life as measured by FACT-G(Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days)
- Changes in Blood Pressure(Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days)
- Changes in Heart Rate(Baseline and then participants will be followed for the duration of the intervention, an expected average of 8 days)
研究者
Dr. Andreas Charalambous
Assistant Professor
Cyprus University of Technology