Music Intervention in Chronic Pain Patients
- Conditions
- AnxietyWell-Being, PsychologicalChronic Pain
- Interventions
- Behavioral: Music intervention in person
- Registration Number
- NCT06436378
- Lead Sponsor
- Laval University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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.
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Musical intervention Music intervention in person This arm will receive a personalized music intervention.
- Primary Outcome Measures
Name Time Method Changes in Composite pain, anxiety, and well-being (reversed) score 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 Outcome Measures
Name Time Method Changes in well-being (reversed) 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.
Changes in Anxiety levels 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.
Changes in Pain levels 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.
Trial Locations
- Locations (1)
Pavillon Louis-Jacques-Casault
🇨🇦Québec, Quebec, Canada