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NCT Number: NCT06436378

Music Intervention in Chronic Pain Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pavillon Louis-Jacques-Casault

Québec, Quebec, G1V 0A6, Canada

Location status: Recruiting

Location contact

Josiane Bissonnette, Ph.D

CONTACT

[email protected]

418-656-2131

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music intervention in person

Behavioral

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.

Primary outcomes

  1. Changes in Composite pain, anxiety, and well-being (reversed) score

    Time frame: The posttest was administered 25 minutes after the pretest

    Change in composite outcome score for pre-test to post-test for the experimental sessions compared with change in the control sessions. The composite score will be obtained by summing the pain (0-10), anxiety (0-10) and well-being (reversed) scores (0-10) from the Edmonton Symptom Assessment Scale Revised. (ESAS-r)

Secondary outcomes

  1. Changes in Pain levels

    Time frame: The posttest was administered 25 minutes after the pretest.

    Change in pain level, as assessed by the Edmonton Symptom Assesment Scale Revised (ESAS-r) on a scale of 0 to 10.

  2. Changes in Anxiety levels

    Time frame: The posttest was administered 25 minutes after the pretest.

    Change in anxiety level, as assessed by the Edmonton Symptom Assesment Scale Revised (ESAS-r) on a scale of 0 to 10.

  3. Changes in well-being (reversed)

    Time frame: The posttest was administered 25 minutes after the pretest.

    Change in well-being (reversed) level, as assessed by the Edmonton Symptom Assesment Scale Revised (ESAS-r) on a scale of 0 to 10.

Other outcomes

  1. Subjective experience

    Time frame: 5 week

    Five open questions will be asked by the facilitator to inquire about the participant's experience. - Tell me about your experience with the intervention program. - What is your overall opinion of the intervention? - What did listening to the recordings bring you? - What did you like least about the intervention? - What would you change about the intervention? - Have you had any prior experience with this type of intervention?

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Marie Pinard, Md, MA

CONTACT

[email protected]

418 656-2131 ext. 404519

Josiane Bissonnette, Ph.D.

CONTACT

[email protected]

418-656-2131

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Université de Montréal

Registry information

Official study title

Feasibility and Efficacy of Music Intervention on Pain, Anxiety, and Well-being in Chronic Pain Patients

Acronym: MusicCPP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 31, 2024
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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