Promotion of Emotional Well-being in Hospitalized Cancer Patients by Virtual Reality
2017年3月31日 更新者：Rosa María Baños Rivera、University of Valencia
A Brief Psychological Intervention Using Virtual Reality for the Promotion of Emotional Well-being in Hospitalized Cancer Patients
The aim of this study is to analyze the effect of a brief psychological intervention supported by Information and Communication Technologies, on the subjective well-being of hospitalized cancer patients.
Participants are randomly assigned to one of 2 conditions: Intervention condition (4 Virtual reality sessions) and Control condition (waiting list control group).
研究概览
研究类型
介入性
注册 (实际的)
76
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- adults with any cancer diagnosis
- hospitalized for at least 1 week
- Karnofsky functional state ≥50
- life expectancy ≥2 months
Exclusion Criteria:
- serious psychopathology
- cognitive impairment
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Intervention
The entire intervention is composed by four 30 minutes sessions along 1 week.
Its focus is on the promotion of well-being by the use of two virtual environments ("Emotional Parks" and "Walk through Nature").
These environments allow participants to involve in different exercises (working with self statements, videos, images, slow breathing, focus on the present exercises) with the purpose of increase positive emotional states.
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Participants receive two sessions oriented to joy and two focused on relax.
In the first 2 sessions patients can choose the environment ("Emotional Parks" or "Walk through Nature") and in the following ones participants visit the alternate environments.
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无干预：Control
Participants receive the medical treatment deliver by the hospital.
They fulfill several questionnaires at two moments (pre and post 1 week after).
After this, they have the possibility to receive the psychological intervention.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983; adapted version of Tejero, Guimerá, Farré & Peri, 1986)
大体时间：change from baseline at 1 week
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change from baseline at 1 week
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Fordyce Happiness Scale (Fordyce, 1988).
大体时间：change from baseline at 1 week
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change from baseline at 1 week
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Visual Analog Scale: Mood.
大体时间：4 days along 1 week
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Subjective mood change after each intervention session.
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4 days along 1 week
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Visual Analog Scale: Emotional State. Change from pre to post session.
大体时间：4 days along 1 week
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Assessment of general mood, joy, sadness, anxiety, relax and vigor (7-point Likert scale)
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4 days along 1 week
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Visual Analog Scale: Physical Discomfort. Change from pre to post session.
大体时间：4 days along 1 week
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Presence of pain, fatigue and physical discomfort (11-point Likert scale)
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4 days along 1 week
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Visual Analog Scale: Satisfaction with the Session Scale.
大体时间：4 days along 1 week
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Level of pleasantness and perceived usefulness of each session (11-point Likert scale)
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4 days along 1 week
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Satisfaction with Intervention Scale (adapted version of Borkovec and Nau's, 1972)
大体时间：1 week
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Assesses satisfaction, recommendation, utility and discomfort (11-point Likert scale)
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1 week
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The Brief Illness Perception Questionnaire (BIPQ) (Broadbent et al., 2006)
大体时间：baseline
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This instrument has 9 items aimed to evaluate the cognitive and emotional representation of the illness (consequences, timeline, personal control, treatment control, identity, concern, emotional response, illness coherence and causes).
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baseline
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Personal meaning of the illness (ad-hoc).
大体时间：baseline
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Patient has 6 alternatives of illness meaning (Loss, threat, challenge, blame-others, blame-self and opportunity).
In addition to these alternatives, participant can add any other personal meaning.
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baseline
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Visual Analog Scale: Optimism
大体时间：baseline
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11-point scale (not at all - completely)
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baseline
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Visual Analog Scale: Life satisfaction
大体时间：baseline
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7-point scale (no satisfaction - completely satisfied)
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baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2010年7月1日
初级完成 (实际的)
2011年12月1日
研究完成 (实际的)
2011年12月1日
研究注册日期
首次提交
2017年3月21日
首先提交符合 QC 标准的
2017年3月31日
首次发布 (实际的)
2017年4月6日
研究记录更新
最后更新发布 (实际的)
2017年4月6日
上次提交的符合 QC 标准的更新
2017年3月31日
最后验证
2017年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Virtual Reality Intervention的临床试验
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Southern Methodist UniversityKing's College London完全的
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IRCCS Eugenio Medea招聘中
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Hospital Universitari Vall d'Hebron Research InstituteUniversitat Autonoma de Barcelona招聘中
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Ege Miray Topcu完全的
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Hospital Universitari Vall d'Hebron Research Institute主动，不招人