Brief Summary

Promoting good care, well-being and quality of life for geriatric patients is a long-standing initiative in Quebec, and one in which the Institut Universitaire de Gériatrie de Montréal (IUGM) has always been a leader. For example, the IUGM played a major role in drafting the reference framework for the AAPA (approach adapted to the needs of the elderly), which was introduced by the Ministère de la Santé et des Services Sociaux in 2011. The investigator propose to continue this work by focusing in this project on the development of a new intervention aimed at the well-being and quality of life of geriatric patients and based on music and VR. Thee investigator hypothesize (1) that a VR headset-based intervention based on listening to and observing a concert of musicians playing classical music is feasible for patients hospitalized at the IUGM's URFI and in patients attending the geriatric outpatient clinic, and (2) that this intervention can improve their mental health - i.e. their positive emotions, well-being and quality of life - and reduce their anxiety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2024

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 22, 2024

Last Update Submit

February 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasability

    To determine if investigator is able to recruit 80 patients in 6 months, with a consent rate of 80% or more and less than 20% of withdrawal

    6 months

Secondary Outcomes (5)

  • Emotions variation

    1 day

  • Affect variation

    1 day

  • Well-Being Variation

    1 day

  • Quality of life variation

    1 day

  • Anxiety variation

    1 day

Study Arms (2)

Intervention

EXPERIMENTAL

participants will listen to and watch a concert of musicians playing classical music through a VR headset

Other: VR

Control

ACTIVE COMPARATOR

participants will simply listen to the concert through headphones

Other: Music only

Interventions

VROTHER

The participant will be seated comfortably in an armchair. The intervention will last 15 minutes. It will take place once. This group's intervention will be to watch and listen with VR headphones to a concert by a group of musicians playing music.

Intervention

The participant will be seated comfortably in an armchair. The intervention will last 15 minutes. It will take place once. This group's intervention will be to listen with conventional headphones to a concert by a group of musicians playing music.

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be hospitalized at the URFI of the IUGM, or being a patients attending the geriatric outpatient clinic
  • be 60 years of age or older,
  • not have an acute intercurrent pathology in the week preceding the procedure and during the two days of the procedure,
  • have no psycho-behavioural disorders,
  • no major neurocognitive disorder at a severe stage,
  • no severe visual or hearing impairment,
  • no vestibular balance disorders,
  • give written consent to participate in the study.

You may not qualify if:

  • Participate in another concurrent experimental clinical study, to avoid interference with our study.
  • Do not understand written or spoken French or English. The participants are French and/or English speakers, and the questionnaires are only available in these 2 languages.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRIUGM

Montreal, Quebec, H3W 1W5, Canada

Location

MeSH Terms

Conditions

Nervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, director of AgeTeQ Lab at CRIUGM

Study Record Dates

First Submitted

February 22, 2024

First Posted

March 6, 2024

Study Start

May 1, 2024

Primary Completion

October 23, 2024

Study Completion

October 23, 2024

Last Updated

February 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations