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
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RECRUITING
NA
36 participants
INTERVENTIONAL
2024-05-28
2025-12-31
Brief Summary
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The main objective is to evaluate if the intervention program will significantly reduce participants composite score of pain, anxiety, and well-being (reversed) as evaluated by the Edmonton symptom assessment scale (ESAS-r) immediately after the intervention, and whether this improvement will be significantly greater than that of control sessions.
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Detailed Description
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The second group (control group) will evaluate their pain, anxiety, and well-being scores 20 minutes apart once per week for the first 2 weeks.Participants will continue their daily activities between the two measurement times. During the next 2 weeks, the participants will listen to online musical sessions once per week and will again evaluate their levels of pain, anxiety, and well-being before and after each intervention session.
The main objective of this randomized controlled trial is to evaluate the immediate effect of a personalized music intervention for the experimental group/in-person intervention on a composite score of pain, anxiety, and well-being (reversed), compared to the control group/no intervention sessions, as measured by the ESAS-r. The secondary objective is to assess the evolution of each of these three ESAS-r variables (pain, anxiety, well-being) from pre-test to post-test compared with changes in these variables in the control group/no intervention sessions.
The differences between in-person musical interventions and online musical sessions, as well as the feasibility and adherence of participants to an online music intervention program, will also be assessed. Furthermore, the effect of a music session preceded by a period of relaxation compared to the effect of a musical session alone, and the experiential dimensions experienced, will be evaluated.
At the end of the experiment, both groups will be interviewed to analyze their comments regarding the interventions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Musical intervention
This arm will receive a personalized music intervention.
Music intervention in person
The music intervention consists of listening to two or three pieces of music chosen by each participant that bring them a sense of well-being. One of the two music intervention sessions will be preceded by a moment of relaxation, during which participants will be asked to focus their attention on their breathing, on relaxation, and on the process of self-absorption. This intervention, preceded by a brief moment of relaxation, will take place during the first session for half of the participants and during the second session for the other half.
No musical intervention
This arm will carry out its daily activities and will be assessed using the same measures at the beginning of each session and after a delay comparable to the duration of the intervention administered in the experimental group.
No interventions assigned to this group
Interventions
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Music intervention in person
The music intervention consists of listening to two or three pieces of music chosen by each participant that bring them a sense of well-being. One of the two music intervention sessions will be preceded by a moment of relaxation, during which participants will be asked to focus their attention on their breathing, on relaxation, and on the process of self-absorption. This intervention, preceded by a brief moment of relaxation, will take place during the first session for half of the participants and during the second session for the other half.
Eligibility Criteria
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Inclusion Criteria
* Suffering from chronic pain and actively attending the pain clinic at the CHU de Québec-Université Laval;
* Have an email and be able to respond to online questionnaires using a computer, tablet, or phone;
* Have satisfactory or corrected hearing;
* Understand French;
* Be able to travel to Université Laval.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Université de Montréal
OTHER
Laval University
OTHER
Responsible Party
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Josiane Bissonnette
Professor
Principal Investigators
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Anne Marie Pinard, Md, MA
Role: PRINCIPAL_INVESTIGATOR
CIRRIS
Locations
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Pavillon Louis-Jacques-Casault
Québec, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-6620
Identifier Type: -
Identifier Source: org_study_id
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