试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Change in Pain Catastrophizing Scale Score
研究概览
简要总结
The general scope of the study involves meditation and its effects on pain management, narcotic use, and emotional well-being. Half of the participants will receive access to a meditation app, which they will be asked to use for at least 10 minutes every day for 6 weeks, while the other participants will be in the waitlist group and will receive a subscription to the meditation app after the 6 week study period ends. All participants will be asked to complete a set of questionnaires
详细描述
Chronic pain affects an estimated 11.2% of the US population, costs the United States approximately $635 billion per year in medical expenses and lost productivity, and fuels the current epidemic of opioid addiction. Understanding alternate approaches to chronic pain management is an imperative given new guidelines for the treatment of pain, and preliminary studies indicate that meditation programs may reduce the suffering and distress that accompanies chronic pain. However, much of the research on meditation for pain has examined the effects of scheduled group interventions, delivered in-person by instructors over the course of several weeks. Far less research has looked at the delivery method that is most common and arguably most sustainable for busy adults, namely, smart phone delivered Contemplative Applications (Apps) for Well-being (CAWs). The proposed study will examine the use and impact of a meditation apps in the context of pain. Participants will be randomized to either app or a wait-list group, and will be assessed in terms of self-reported pain, distress, narcotic use. To assess efficacy, the researchers will examine the longitudinal changes in all measures in the mindfulness app group, compared to wait-list control groups.
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
- None
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
- •Emory Healthcare patient
排除标准
- •Non-english speaking patients
- •Children, prisoners or other vulnerable populations
研究组 & 干预措施
Headspace app
Participants randomized to use the mindfulness app for 6 weeks.
干预措施: Headspace app (Behavioral)
Waitlist control group
This group will receive treatment as usual for 6 weeks. After the completing the 6-week surveys, the waitlist group will receive a subscription to the Headspace app.
结局指标
主要结局
Change in Pain Catastrophizing Scale Score
时间窗: Baseline, Week 3, Week 6, Week 14
The Pain Catastrophizing Scale is a 13-item inventory that measures 3 elements of the perception of the intensity of pain (rumination, magnification, feeling helpless). Participants indicate the degree to which they agree with statements related their pain by selecting 0 = not at all, 1 = to a slight degree, 2 = to a moderate degree, 3 = to a great degree, 4 = all the time. There are three subscale scores assessing rumination, magnification and helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel. helplessness. All subscales are summed to produce a total score ranging from 0 to 52 with higher scores indicating the participant is having more thoughts about the pain they feel.
Change in Brief Pain Inventory
时间窗: Baseline, Week 3, Week 6, Week 14
The Brief Pain Inventory is a 9-item inventory that measures both pain severity and pain interference in daily functioning with 2 scales. Questions are answered on an 11-point Likert scale from 0 to 10 and scales are scored by obtaining the mean for two separate scales: pain severity and pain interference.
Change in Current Opioid Misuse Measure (COMM) Score
时间窗: Baseline, Week 3, Week 6, Week 14
The COMM is a 17-item questionnaire assessing the aberrant medication-related behaviors of patients with chronic pain. Participants indicate how often they have experienced specific aberrant medication-related behaviors in the past 30 days on a scale from 0 (never) to 4 (very often). Total scores range from 0 to 68 with higher scores indicating more problematic behaviors.
次要结局
- Change in Physical Functioning Subscale (PF-10) Score(Baseline, Week 3, Week 6, Week 14)
- Change in Depression Anxiety and Stress Scale (DASS) Score(Baseline, Week 3, Week 6, Week 14)
- Change in PROMIS Loneliness - Fixed Form Score(Baseline, Week 3, Week 6, Week 14)
- Change in Basel Assessment of Adherence Immunosuppression Scale Score(Baseline, Week 3, Week 6, Week 14)
- Change in Brief Coping with Problems Experienced (COPE) Inventory(Baseline, Week 3, Week 6, Week 14)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Social Functioning - Short Form Score(Baseline, Week 3, Week 6, Week 14)
研究者
Jennifer Mascaro
Assistant Professor
Emory University