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Golden Age: Virtual Reality and Mindfulness

Golden Age: Virtual Reality and Mindfulness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05966844
Enrollment
40
Registered
2023-08-01
Start date
2023-07-01
Completion date
2023-10-30
Last updated
2024-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Lifestyle, Psychological Wellbeing

Keywords

healthy lifestyle, psychological wellbeing

Brief summary

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

Detailed description

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.

Interventions

BEHAVIORALMindfluness and Virtual Reality

They will undergo six mindfulness sessions in virtual reality for about six weeks. One session per week of approximately 5-10 minutes.

Sponsors

Idego srl
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

The project will investigate the effects of a Mindfulness pathway in RV on factors that hinder the adoption of healthy eating behaviour in the elderly population. Six meetings of about 5-10 minutes each, one per week, are planned. A randomised controlled trial (RCT) is proposed with two groups: * An experimental group of 20 elderly people who will do the trial in the RV. * Another control group, again of the same size, which will simply fill out simply twice the same battery of tests: one at the beginning of the project and the other at the end.

Eligibility

Sex/Gender
ALL
Age
64 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in levels of GAD-7 test scoresTwo monthsThe 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 scoresTwo monthsThe 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 scoresTwo monthsThe 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 scoresTwo monthsThe 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.

Secondary

MeasureTime frameDescription
Level of acceptance and usability of devicesTwo monthsThrough a specifically designed questionnaire, the extent to which the devices used are perceived as useful, easy to use and accepted will be assessed. Questions on a 5-point likert scale will be used.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026