Feasibility and Efficacy of Remotely Monitored Home-based Listening to Preferred Music for Pain in Older Adults With Low Back Pain: A Pilot Study of Feasibility and Acceptability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adherence rate
研究概览
简要总结
The purpose of this study is to examine the feasibility and acceptability of listening to 20 minutes of preferred style of music twice-daily for 4 consecutive days on pain among 20 community-dwelling older adults with lower back pain (LBP)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •self-report of Lower back pain (LBP)
- •LBP in the past 3 months with an average rating of at least 30 on a 0 - 100 NRS for pain
- •intact cognition
- •no plans to change their pain medication regimens during the study time
- •can read and understand English
- •can travel to the study center
- •agree to sign an informed consent
排除标准
- •deaf or have severe hearing loss
- •pregnant or lactating
- •have an implantable pain-reducing device
- •history of hospitalization within the preceding year for psychiatric illness
- •diagnosis of Raynaud's disease
- •have a functional limitation that requires the use of an ambulatory aid such as a cane, walker, or wheelchair
- •history of brain surgery, brain tumor, or stroke
- •severe depression (PROMIS Depression T-score ≥ 70) (Kroenke et al., 2020)
- •severe anxiety (PROMIS Anxiety ≥ 70) (American Psychiatric Association, 2013)
- •Mini-Mental State Examination score less than 24 (Creavin, Wisniewski, Noel-Storr, et al., 2016)
研究组 & 干预措施
Treatment
干预措施: Music Listening (Other)
结局指标
主要结局
Adherence rate
时间窗: 6 months from start of study
Assessed as number completing all measures divided by number enrolled
Enrollment rate: Assessed as number enrolled or number who met inclusion criteria
时间窗: 6 months from start of study
Attrition rate
时间窗: 6 months from start of study
Assessed as number not completing the study divided by number enrolled at baseline
Treatment acceptability: Measured by the treatment acceptability and preference scale(TAP
时间窗: Baseline
Assess perceived acceptability of treatment using TAP in four categories of appropriateness, effectiveness, suitability, and willingness to adhere on a scale ranging from 0 (not at all) to 4 (very much).
Treatment acceptability: Measured by the treatment acceptability and preference scale(TAP)
时间窗: 5 days after baseline(1 day after completion of intervention)
Assess perceived acceptability of treatment using TAP in four categories of appropriateness, effectiveness, suitability, and willingness to adhere on a scale ranging from 0 (not at all) to 4 (very much).
次要结局
- Anxiety as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form(Baseline)
- Depression as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form(Baseline)
- Pain as measured by the numerical rating scale (NRS)(post intervention (day 5))
- Change in brain activation in the motor and somatosensory cortex as measured by functional near-infrared spectroscopy (fNIRS)(Baseline and post-intervention (Day 5))
- Change in conditioned pain modulation (CPM)(Baseline and post-intervention (Day 5))
- Change in heart rate variability (HRV)(Baseline and post-intervention (Day 5))
- Pain as measured by the numerical rating scale (NRS)(Baseline)
- Pain as measured by the numerical rating scale (NRS)(day 1)
- Pain as measured by the numerical rating scale (NRS)(day 2)
- Pain as measured by the numerical rating scale (NRS)(day 3)
- Pain as measured by the numerical rating scale (NRS)(day 4)
研究者
Setor K. Sorkpor
Student
The University of Texas Health Science Center, Houston