Music, Virtual Reality for Patients in IUGM

Music, Virtual Reality and Mental Health of Inpatients in the Intensive Functional Rehabilitation Unit and Patients in the IUGM Geriatric Outpatient Clinic: Pilot Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Aging; Disorder, Neurologic
• Intervention / Treatment: Other: VR; Other: Music only

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3W 1W5
      • CRIUGM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; participants will listen to and watch a concert of musicians playing classical music through a VR headset	Other: VR; 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.
Active Comparator: Control; participants will simply listen to the concert through headphones	Other: Music only; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotions variation	To quantify and compare variations in Visual Analog Mood Scales (VAMS) score between the intervention group (listening to and watching musicians with VR headphones) and the control group (listening to music with headphones). This scale examines 8 emotions represented by ideogrammatic icons. It contains 2 positive emotions (happy and energetic) and 6 negative emotions (scared, confused, sad, angry, tired, tense). Each emotion is linked to a neutral face by a line. Participants will be asked to place a mark on the line at the point that represents the intensity of the emotion they are feeling. The distance in millimetres from the neutral face corresponds to the score (e.g., the further away from the neutral face, the greater the emotion). A higher positive emotion score means the participant feels better, and a higher negative emotion score means the patient feels worse.	1 day
Affect variation	To quantify and compare variations in scores on Positive and negative Affect schedule (PANAS) between the intervention group (listening to and watching musicians with VR headphones) and the control group (listening to music with headphones). This positive and negative affectivity scale is a questionnaire designed to measure the valence and activation (i.e. intensity) of a person's affects. It comprises two scales. The first measures positive affect, the second negative affect. Each scale comprises 10 items, for a total of 20. Scores range from 10 to 50 for the negative affect score and from 10 to 50 for the positive affect score, respectively, with a low score representing the lowest levels of negative affect, and a high score representing high levels of positive affect. A high negative affect score reveals psychological distress involving a variety of unpleasant emotions, while a low score reflects calm and serenity.	1 day
Well-Being Variation	To quantify and compare variations in scores on Warwick Edinburgh mental well-being scale measuring well-being between the intervention group (listening to and watching musicians with VR headphones) and the control group (listening to music with headphones). This scale is made up of 14 positively worded items and produces scores ranging from 14 (i.e. no well-being) to 70 (i.e. complete well-being).	1 day
Quality of life variation	To quantify and compare variations in scores on Eq-5D scale measuring quality of life between the intervention group (listening to and watching musicians with VR headphones) and the control group (listening to music with headphones). This test is a standardized measure of health status developed by the EuroQol group to provide a simple, generic measure of health for clinical and economic evaluation. It provides a simple descriptive profile and a single index value for health status. The EQ-5D consists of two parts: (1) a five-question questionnaire with a score per question ranging from 1 (i.e. no problem) to 5 (i.e. a more serious problem), (2) and a visual analog scale indicating how good or bad the participant's health is. This scale is numbered from 0 (i.e. the worst health the participant can imagine) to 100 (i.e. the best health the participant can imagine).	1 day
Anxiety variation	To quantify and compare variations in scores on General Anxiety Disorder - 7 scale measuring anxiety between the intervention group (listening to and watching musicians with VR headphones) and the control group (listening to music with headphones). This is a 7-item scale (each item is rated on a Likert scale ranging from "not at all" to "almost every day"). The maximum score is 21, and the higher the score, the greater the anxiety.	1 day

Collaborators and Investigators

• Sponsor: Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): October 23, 2024
• Study Completion (Actual): October 23, 2024

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: 2024-2064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No