5-minute Mindful Pain Management Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intervention Adherence
研究概览
简要总结
This project is a single-site, two-arm, pilot study assessing the feasibility and preliminary efficacy of a 5-minute Mindful Mapping intervention for adults with chronic musculoskeletal pain (n=60) relative to a time- and attention-matched control condition.
详细描述
This was a two-arm (Mindful Mapping vs. Serial Sevens), remotely delivered, parallel-group, pilot RCT. All procedures were approval by the local IRB and preregistered (NCT06394765). Written informed consent was obtained from all participants prior to their inclusion in the study. Participants were randomly assigned (1:1) to either the Mindful Mapping intervention (n=30) or a control condition, Serial Sevens (n=30). Randomization was performed using a computer-generated sequence.
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
- Single (Participant)
盲法说明
Participants will be randomized (1:1) using a computer-generated randomization sequence created by the PI prior to the study start date.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •having a chronic pain diagnosis
- •being able not to commit to another (new) treatment during the course of the study
- •understanding English instructions fluently
- •Being 18 and above
排除标准
- •having learned to practice mindfulness meditation any time in the past
- •being unable to perform most basic tasks due to pain or pain treatment
研究组 & 干预措施
Mindful Mapping
干预措施: Mindful Mapping (Behavioral)
Serial Sevens
干预措施: Serial Sevens (Behavioral)
结局指标
主要结局
Intervention Adherence
时间窗: 5 minutes
Examine the percentage of participants completing their 5-minute intervention session
Randomization Feasibility
时间窗: 3 months
Examine randomization rates during the 3 months planned for recruitment.
Therapeutic Skill Use Adherence
时间窗: 2 weeks
Examine the frequency of therapeutic skill use during the 2-week, post-intervention, self-management period.
Recruitment Feasibility
时间窗: 3 months
Examine recruitment rates during the 3 months planned for recruitment.
次要结局
- Treatment Acceptability(Completed at 2- and 6-week follow-ups)
- Global Impression of Change(Completed at 2- and 6-week follow-ups)
研究者
Adam Hanley
Associate Professor
Florida State University