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临床试验/NCT05292703
NCT05292703已完成不适用

Olfaction, Virtual Reality and Art in Health

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2022年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
change in Warwick-Edinburgh Mental Well-Being Scale (WEMBS)

研究概览

简要总结

The main objective of this study is to compare the well-being of a group of seniors participating for a month in face-to-face sessions of artistic and olfactory activities with another group of seniors performing the same type of activity for a month but remotely with connection to a dedicated application.

Well-being, Quality of Life, Health, Apathy and Olfactory identification scales are proposed before the intervention, at the end of the intervention (V0, V1), then 3 months after the end of the intervention. A Usability Evaluation questionnaire will be sent to the participants of the remote group after use (V1).

详细描述

Health is defined by WHO as a condition of mental, physical and social well-being. Cognitive aging markers have been defined such as apathy and deterioration of olfactory identification. Artistic creation can be used to improve health, and olfactory stimulation can improve olfactory abilities.

The main objective of this study is to compare the well-being of a group of seniors participating for a month in face-to-face sessions of artistic and olfactory activities with another group of seniors performing the same type of activity for a month but remotely with connection to a dedicated application.

Well-being, Quality of Life, Health, Apathy and Olfactory identification scales are proposed before the intervention, at the end of the intervention (V0, V1), then 3 months after the end of the intervention. A Usability Evaluation questionnaire will be sent to the participants of the remote group after use (V1).

Concerning the categorical variables, the frequencies will be calculated. First the basic characteristics (age, sex, etc.) will be described and compared for each group (i.e., intervention versus control) using parametric and non-parametric tests according to the distribution of variables. Regarding the quantitative variables, the distribution will be studied (mean, median, mode, minimum, maximum, confidence interval around the mean, standard deviation). The statistical tests used will be unpaired T-tests or Mann-Whitney U-tests to compare the two appropriate groups depending on the groups.

Several effects are expected following the practice of participatory artistic workshops. First, an improvement in well-being is expected, measured by the WEMBS scale. An immediate and medium-term benefit is expected, which will be measured 3 months after the end of the workshops. In a second step, an improvement in the Quality of Life and the state of Health is expected. Measurement data for early markers of cognitive decline, Apathy and Olfactory identification should improve. In the long term and more generally, the validation of the proposed study could make it possible to legitimately ensure its dissemination on a larger scale, and to strengthen the involvement of seniors with public users in participatory artistic programs in person or remotely, in order to ensure them a quality ageing. The data will be compared a posteriori with international data in order to compare the effects of artistic workshops in person or remotely. An acceptability questionnaire will assess the adherence of seniors to a distance and virtual artistic program before and after use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • aged 65 or more
  • Get internet access and an electronic tool such as a smartphone or tablet,
  • Be fluent in French language.
  • Be available during participatory artistic workshop sessions.
  • Be affiliated with Social Security

排除标准

  • Not fluent in french language,
  • Present sensory and/or cognitive deterioration identified by the investigator during inclusion,
  • Being under guardianship or curatorship or safeguard of justice,
  • Being unable to give or sign consent

结局指标

主要结局

change in Warwick-Edinburgh Mental Well-Being Scale (WEMBS)

时间窗: At the beginning, after the session and 3 months after the end of the session

The 14-item scale WEMWBS has 5 response categories, summed to provide a single score. The items are all worded positively and cover both feeling and functioning aspects of mental wellbeing, thereby making the concept more accessible.

次要结局

  • Quality of life scale (EQ5D)(At the beginning, after the session and 3 months after the end of the session)
  • Olfactory identification test (Bellecôte)(At the beginning, after the session et 3 months after the end of the session)
  • Health scale (CESAM)(At the beginning, after the session and 3 months after the end of the session)
  • Apathy scale (b-DAS)(At the beginning, after the session and 3 months after the end of the session)
  • User experience evaluation questionnaire (Usability Evaluation)(After the session and 3 months after the end of the session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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