Clinical trial NCT06436378: Music Intervention in Chronic Pain Patients
Official title: Feasibility and Efficacy of Music Intervention on Pain, Anxiety, and Well-being in Chronic Pain Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Anxiety
Well-Being, Psychological
Keywords: chronic pain
music
anxiety
well-being
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Université de Montréal
First posted: 2024-05-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years and older;
* 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:

* None

Primary outcomes:
measure: Changes in Composite pain, anxiety, and well-being (reversed) score
timeFrame: The posttest was administered 25 minutes after the pretest
Secondary outcomes:
measure: Changes in Pain levels
timeFrame: The posttest was administered 25 minutes after the pretest.
measure: Changes in Anxiety levels
timeFrame: The posttest was administered 25 minutes after the pretest.
measure: Changes in well-being (reversed)
timeFrame: The posttest was administered 25 minutes after the pretest.
Other outcomes:
measure: Subjective experience
timeFrame: 5 week
Locations:
city: Québec
country: Canada
facility: Pavillon Louis-Jacques-Casault
state: Quebec
Study officials:
affiliation: CIRRIS
name: Anne Marie Pinard, Md, MA
role: PRINCIPAL_INVESTIGATOR
References: