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Music Intervention in Chronic Pain Patients (MusicCPP)

L

Laval University

Status

Enrolling

Conditions

Chronic Pain
Anxiety
Well-Being, Psychological

Treatments

Behavioral: Music intervention in person

Study type

Interventional

Funder types

Other

Identifiers

NCT06436378
2023-6620

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

Musical intervention
Experimental group
Description:
This arm will receive a personalized music intervention.
Treatment:
Behavioral: Music intervention in person
No musical intervention
No Intervention group
Description:
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.

Trial contacts and locations

1

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Central trial contact

Anne Marie Pinard, Md, MA; Josiane Bissonnette, Ph.D.

Data sourced from clinicaltrials.gov

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