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临床试验/NCT05966844
NCT05966844已完成不适用

Golden Age: Virtual Reality and Mindfulness

Idego srl2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Idego srl
入组人数
40
试验地点
2
主要终点
Change in levels of GAD-7 test scores

研究概览

简要总结

The aim of the research is to identify innovative methodologies to improve the psychological well-being of ageing people.

详细描述

With regard to the objectives of the Golden Age project, a software of Immersive Virtual Reality (VR) for people over 65. The application aims to improve the psychological wellbeing of ageing people, facilitating the removal of barriers that may represent a risk factor with respect to the assumption of a healthy and correct nutrition.

In particular, the elderly will be exposed to naturalistic scenarios in Virtual Reality combined with Mindfulness audio tracks. The practice of Mindfulness in Virtual Reality will be used to prevent and intervene on depressive symptoms, stress and anxiety, which represent the main obstacles to the adoption of healthy behaviours in the elderly person.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • Average age over 64
  • MMSE between 20 and 30
  • Adequate vision and hearing to see scenarios and hear tracks
  • sufficient ability to understand procedures and communicate with staff

排除标准

  • High levels of depression combined with other psychological risk indices (such as suicidal thoughts)
  • Current use of narcotics or substance abuse

结局指标

主要结局

Change in levels of GAD-7 test scores

时间窗: Two months

The GAD-7 test is a validated test for the detection of generalized anxiety disorder. GAD-7 total score for the seven items ranges from 0 to 21. Higher scores mean worse outcome.

Change in levels of PHQ-9 test scores

时间窗: Two months

The PHQ-9 test is a validated test for the detection of depression. The PHQ-9 score ranges from 0 to 24. Higher scores mean worse outcome.

Change in Perceived Stress Scale test scores

时间窗: Two months

The Perceived Stress Scale (PSS) test is a validated test for detecting general stress levels. The minimum score is 0 and the maximum score is 40. Higher scores mean worse outcome.

Change in Mindful Awareness Attention Scale scores

时间窗: Two months

The Italian Adaptation of the Mindful Awareness Attention Scale is a questionnaire investigating the presence of mindfulness skills.The minimum score is 15 and the maximum score is 105. A high score indicates an improvement.

次要结局

  • Level of acceptance and usability of devices(Two months)

研究者

发起方
Idego srl
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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