NCT04867967已完成不适用
Yoga and Mindfulnes-based-stress-reduction for Patients With Tension-type Headache
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Headache Frequency
研究概览
简要总结
Primary study objectives
- evaluate the short-term effect of yoga intervention in addition to routine care on headache frequency in patients with frequent or chronic tension-type headache compared to routine care alone (waiting group).
- to evaluate the short-term effect of yoga intervention in addition to routine care on headache frequency in patients with frequent episodic or chronic tension-type headache compared with stress management through mindfulness-based stress reduction (MBSR) in addition to routine care.
Secondary study objectives
Evaluation of the medium-term effect of the intervention on headache frequency as well as the short- and medium-term effect on the secondary target parameters in comparison to the waiting group and MBSR. Further evaluation of the safety and acceptability of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •episodic or chronic tension-type headache according to ICHD-3 definition
排除标准
- •medication induced headache according to ICHD-3 definition
- •Cluster-headache according to ICHD-3 definition
- •serious chronic systemic or acute physical or mental illness
- •Pregnancy
- •actual in a yoga or MBSR class
结局指标
主要结局
Headache Frequency
时间窗: post-intervention (8 weeks)
Headache Frequency self-reported by a headache diary
次要结局
- Stress(follow-up (20 weeks))
- Pain catastrophizing(follow-up (20 weeks))
- Safety(follow-up (20 weeks))
- Pain medication use(follow-up (20 weeks))
- Pain Intensity(follow-up (20 weeks))
- Duration of headache episodes(follow-up (20 weeks))
- Pain acceptance(follow-up (20 weeks))
- Mindfulness(follow-up (20 weeks))
- Headache Frequency(follow-up (20 weeks))
- Body Awareness(follow-up (20 weeks))
- Headache related disability(follow-up (20 weeks))
- Health-related quality of life(follow-up (20 weeks))
- Anxiety(follow-up (20 weeks))
研究者
Holger Cramer
PD Dr. rer. medic
Universität Duisburg-Essen
研究点 (2)
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