Does Psychoeducation Improve the Pain Relief Derived From a Brief Mindfulness-Based Intervention Delivered in a Clinic Waiting Room
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Pain Unpleasantness Numeric Rating Scale
研究概览
简要总结
This project is a single-site, five-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room psychoeducation about mindfulness impacts the degree of pain relief they experience during a mindfulness-based intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Receiving pain treatment at Tallahassee Orthopedic Center
- •Understanding English instructions fluently
- •Being 18 years of age or older
排除标准
- •Unable to consent because of physical or mental incapacity.
研究组 & 干预措施
Pain Psychoeducation
In the pain psychoeducation intervention, participants will be randomized to listen to a three-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.
干预措施: Pain Psychoeducation (Behavioral)
Mindfulness without Psychoeducation
In the mindfulness without psychoeducation intervention, participants will be randomized to listen to a three-minute mindfulness practice consisting of 1 minute of mindful breathing, 1 minute of mindful mapping, and 1 minute of mindfulness of personal meaning.
干预措施: Mindfulness without Psychoeducation (Behavioral)
1 Minute Psychoeducation with 2 Minutes of Mindfulness (Pain Focus)
In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Pain Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindful mapping.
干预措施: 1 Minute Psychoeducation with 2 Minutes of Mindfulness (Pain Focus) (Behavioral)
1 Minute Psychoeducation with 2 Minutes of Mindfulness (Meaning Focus)
In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Meaning Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindfulness of personal meaning.
干预措施: 1 Minute Psychoeducation with 2 Minutes of Mindfulness (Meaning Focus) (Behavioral)
2 Minutes of Psychoeducation with 1 Minute of Mindfulness
In the 2 Minutes of Psychoeducation with 1 Minute of Mindfulness intervention, participants will be randomized to listen to a 2 minute of psychoeducation about mindfulness and 1 minute of mindful breathing.
干预措施: 2 Minutes of Psychoeducation with 1 Minute of Mindfulness (Behavioral)
结局指标
主要结局
Change in Pain Unpleasantness Numeric Rating Scale
时间窗: Immediately before to after 3-minute audio recording
Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.
次要结局
- Change in Pain Intensity Numeric Rating Scale(Immediately before to after 3-minute audio recording)
- Change in Anxiety Numeric Rating Scale(Immediately before to after 3-minute audio recording)
研究者
Adam Hanley
Principal Investigator
Florida State University