NCT05642039已完成不适用
Effectiveness of Mindfulness Training on the Quality of Life of Hidradenitis Suppurativa Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- HS Quality of Life Measure (HiSQOL) Scores
研究概览
简要总结
The purpose of this research is to investigate the effectiveness of mindfulness training on the quality of life of Hidradenitis Suppurativa (HS) patients. HS can have a profound impact on quality of life.
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
- •Hidradenitis Suppurativa patients registered in the University of Miami Hospital dermatology system. Patients can have lesions present at the time of study participation
排除标准
- •Individuals with any of the following: active drug addictions, untreated Post Traumatic Stress Disorder (PTSD), psychosis or suicidal ideations
- •Adults unable to consent
- •Pregnant women
- •Prisoners
- •Individuals below the age of 18 years old
- •Individuals who do not speak English
研究组 & 干预措施
Mindfulness Course Group
Experimental
Participants will participate in the mindfulness course that would last 6 weeks.
干预措施: Mindfulness Course (Behavioral)
HS Educational Course Group
Experimental
Participants will participate in the mindfulness course that would last 6 weeks.
干预措施: HS Educational Course (Behavioral)
结局指标
主要结局
HS Quality of Life Measure (HiSQOL) Scores
时间窗: Up to 10 weeks
HS quality of life (HiSQOL) has a total score ranging from 0 to 68, with higher scores indicating more severe impact on participant's quality of life
次要结局
- Sleep Quality Scale (SQS) Scores(Up to 10 weeks)
- Dermatology Life Quality Index (DLQI) Scores(Up to 10 weeks)
- Number of participants at each Refined Hurley Classification(Up to 10 weeks)
- Five-Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) Scores(Up to 10 weeks)
- Number of Pain medication Usage(Up to 10 weeks)
- Hidradenitis Suppurativa Physician's Global Assessment Scale (HS-PGA) Scores(Up to 10 weeks)
- Number of work/school days missed(Up to 10 weeks)
- Number of visits to the emergency room(Up to 10 weeks)
- Pain Visual Analog Scale (VAS) Scores(Up to 10 weeks)
研究者
Hadar Lev-Tov
Associate Professor of Clinical
University of Miami
研究点 (1)
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