Music, Virtual Reality for Inpatients in IUGM

Aging Clinical Trial

Official title:

Music, Virtual Reality and the Mental Health of Inpatients in the IUGM's Intensive Functional Rehabilitation Unit: Pilot Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06296199
• Other study ID #: 2024-2064
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
• Contact: Olivier Beauchet, MD
• Phone: 5143403540
• Email: olivier.beauchet[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (2) that this intervention can improve their mental health - i.e. their positive emotions, well-being and quality of life - and reduce their anxiety.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• be hospitalized at the URFI of the IUGM,
• 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.

Related Conditions & MeSH terms

• Aging
• Nervous System Diseases

Intervention

Other:
• VR
The participant will be seated comfortably in an armchair in the room where he or she is hospitalized at URFI. The intervention will last 15 minutes. It will take place over two days, once a day. The intervention will take place in the morning or afternoon, but will always be at the same time for the same participant over the two days. This group's intervention will be to watch and listen with VR headphones to a concert by a group of musicians playing music.
• Music only
The participant will be seated comfortably in an armchair in the room where he or she is hospitalized at URFI. The intervention will last 15 minutes. It will take place over two days, once a day. The intervention will take place in the morning or afternoon, but will always be at the same time for the same participant over the two days. This group's intervention will be to listen with conventional headphones to a concert by a group of musicians playing music.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasability	To determine if investigator is able to recruit 40 patients in 6 months, with a consent rate of 80% or more and less than 20% of withdrawal	6 months
Secondary	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.	2 days
Secondary	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.	2 days
Secondary	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).	2 days
Secondary	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).	2 days
Secondary	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.	2 days