Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2023-07-01
2023-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Explore the Effects of Virtual Reality Natural Environment of Older People
NCT05803460
A Novel VIRTUAL Reality Intervention for CAREgivers of People With Dementia (VirtualCare)
NCT05780476
Home-based Psychoeducation for Older Adults With Frailty: A Randomised Controlled Trial
NCT06415604
Evaluation of the Effectiveness of Virtual Reality Headsets With Hypnotic Scenarios for Hygiene Care in Patients With Alzheimer's Disease or Related Disorders With Behavioral Disturbances
NCT07264439
Trial of a Non-pharmacological Intervention to Prevent Delirium Among Elderly In-patients
NCT03158909
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
* 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.
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mindfulness and Virtual Reality
This group will receive questionnaires at the beginning and end of the trial. In addition, they will undergo six mindfulness sessions in virtual reality for about six weeks. One session per week of approximately 5-10 minutes.
Mindfluness 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.
No intervention
This group will only receive questionnaires at the beginning and end of the experiment
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mindfluness 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Current use of narcotics or substance abuse
64 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Idego srl
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lorenzo Di Natale
Role: PRINCIPAL_INVESTIGATOR
Idego srl
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Idego srl
Rome, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Golden Age 01-2023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.