Effect of Music and Other Audio Recordings for Chronic Pain in Aging Adults: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Pain Intensity Scale
研究概览
简要总结
The long-range goal is to reduce suffering and establish alternative options for older adults experiencing pain. This is a randomized controlled study examining the effect of music on pain management in older adults.
详细描述
Study Objectives:
- Evaluate the efficacy of the music with suggestion intervention for chronic lower back pain in aging adults, with the indication that music with suggestion will significantly decrease subjective measures of pain compared to controls of music without suggestion or an informational recording about chronic pain.
- Evaluate the efficacy of the music with suggestion intervention for sleep in aging adults, with the indication that music with suggestion will significantly improve subjective measures of sleep compared to controls of music without suggestion or an informational recording about chronic pain.
- Evaluate the efficacy of the music with suggestion intervention for mood in aging adults, with the indication that music with suggestion will significantly improve subjective measures of mood compared to controls of music without suggestion or an informational recording about chronic pain.
Recruitment Plan
There will be 66 participants who wish to utilize mind-body interventions as treatment for chronic lower back pain.
The individual's eligibility will be determined using an Inclusion/Exclusion Criteria Screening Checklist containing the criteria listed above. If an individual appears to be eligible, he/she will be educated about the study purpose, procedures, and requirements. If the individual is interested in participating, they will sign a consent form, which may be signed through mail, through electronic platforms such as DocuSign, or in-person. The participant will be scheduled for their first formal education session and informed consent will take place during this session. This education session will take place through a video conference platform. All three groups will meet with a research staff member approximately five times (once during the education session and approximately once per week each following week) throughout the duration of the study. These sessions will take place through a video conference platform.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be at least 50 years of age
- •Participant must regularly experience moderate to severe chronic, lower back pain as determined by a self-reported pain rating of ≥ 5 on 11-point numerical rating scale
- •Duration of pain must be ≥ 6 months
- •Participant must be proficient and able to speak, read, and write in English
- •Participant must have access to a computer or mobile device, Internet, and be willing to participate in virtual sessions and use electronic platforms to complete materials
排除标准
- •Presence of any psychiatric condition or symptom that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking
- •History of mental illness (i.e., psychosis, schizophrenia)
- •Non-English speaker
- •Pain classified as neuropathic as detected by the Pain Detect Questionnaire
结局指标
主要结局
Pain Intensity Scale
时间窗: Daily
Subjective measures of pain intensity, which will be determined using a Pain Intensity Scale. This measure will be completed daily where participants will be asked to rate the intensity of their pain on a scale from 0 (No Pain) to 10 (Very Intense Pain). Higher scores will indicate greater pain intensity.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form(Weekly up to 4 weeks)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety- Short Form(Weekly up to 4 weeks)
- Self-report of medication use(Daily up to 4 weeks)
- Relaxation Visual Analog Scale(Weekly up to 4 weeks)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression-Short Form(Weekly up to 4 weeks)
- Pain Suffering Visual Analogue Scale (VAS)(Weekly up to 4 weeks)
研究者
Gary R. Elkins
Director of Mind-Body Medicine Research Lab
Baylor University