Feasibility and Efficacy of Music Intervention on Pain, Anxiety, and Well-being in Chronic Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Changes in Composite pain, anxiety, and well-being (reversed) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Changes in Composite pain, anxiety, and well-being (reversed) score
时间窗: 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)
次要结局
- Changes in Anxiety levels(The posttest was administered 25 minutes after the pretest.)
- Changes in well-being (reversed)(The posttest was administered 25 minutes after the pretest.)
- Changes in Pain levels(The posttest was administered 25 minutes after the pretest.)
研究者
Josiane Bissonnette
Professor
Laval University