Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436378
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-24
Brief Title:
Music Intervention in Chronic Pain Patients
Sponsor:
Laval University
Organization:
Laval University
Study Overview
Official Title:
Feasibility and Efficacy of Music Intervention on Pain Anxiety and Well-being in Chronic Pain Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MusicCPP
Brief Summary:
The goal of this randomized controlled trial is to evaluate the efficacy of a personalized music intervention program to improve the condition of individuals suffering from chronic pain
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
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
Detailed Description:
The participants n 36 will be randomized into two groups The intervention will last for 4 weeks Once per week for the first 2 weeks the first group will have a personalized musical intervention in person on the university campus and will evaluate their pain anxiety and well-being scores before and after each session For the following 2 weeks the participants will have online access to their music sessions and will also assess their levels of pain anxiety and well-being before and after each intervention session
The second group control group will evaluate their pain anxiety and well-being scores 20 minutes apart once per week for the first 2 weeksParticipants 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 groupin-person intervention on a composite score of pain anxiety and well-being reversed compared to the control groupno 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 groupno 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
The second group control group will evaluate their pain anxiety and well-being scores 20 minutes apart once per week for the first 2 weeksParticipants 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 groupin-person intervention on a composite score of pain anxiety and well-being reversed compared to the control groupno 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 groupno 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None