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Clinical Trials/NCT05292703
NCT05292703
Completed
Not Applicable

Olfaction, Virtual Reality and Art in Health

Centre Hospitalier Universitaire de Nice1 site in 1 country51 target enrollmentOctober 6, 2022
ConditionsElderly People

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Elderly People
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
51
Locations
1
Primary Endpoint
change in Warwick-Edinburgh Mental Well-Being Scale (WEMBS)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 6, 2022
End Date
March 21, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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