Randomisierte Kontrollierte Studie Zur Wirkung Von Yoga Bei Chronischen Kopfschmerzen im Jugendalter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Pain frequency adolescent
研究概览
简要总结
A randomized controlled trial to investigate the efficacy of yoga on tension type headache and / or migraine in adolescents between 12 and 16 years, consisting of a four group design which includes an 12 week yoga course and a three-month follow-up period. Both adolescent and one parent will be randomized either to yoga or no treatment. Primary outcome will be pain frequency in adolescents considering pain catastrophizing of parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent:
- •tension type headache and/or migraine minimum at 4 days per month
- •willingness to participate at least 10 out of 12 yoga sessions
- •physical and cognitive ability to participate in light physical, breathing and relaxation exercises
- •good german language
- •willingness to participate at least 10 out of 12 yoga sessions
- •physical and cognitive ability to participate in light physical, breathing and relaxation exercises
- •good german language
排除标准
- •pregnancy or lactation
- •attending a yoga class within the last 3 months prior to the study
研究组 & 干预措施
adolescent waitlist / parent control
The adolescent will receive the intervention after the follow-up period, while one parent will only answer the questionnaires.
adolescent yoga / parent control
The adolescent will receive an 12 week yoga course, while one parent will only answer the questionnaires.
干预措施: Yoga for adolescents (Behavioral)
adolescent waitlist / parent yoga
One parent will participate in an 12 week yoga course, while the adolescent will receive the intervention after the follow-up period.
干预措施: Yoga for parents (Behavioral)
adolescent yoga / parent yoga
Both adolescent and parent will participate in an 12 week yoga course at the same time.
干预措施: Yoga for adolescents (Behavioral)
adolescent yoga / parent yoga
Both adolescent and parent will participate in an 12 week yoga course at the same time.
干预措施: Yoga for parents (Behavioral)
结局指标
主要结局
Pain frequency adolescent
时间窗: Week 12
Measurement of pain frequency after yoga intervention via headache diary
次要结局
- Pain disability adolescent self-assessment(Week 24)
- Pain disability adolescent external assessment(Week 24)
- Pain coping adolescent(Week 24)
- Pain frequency adolescent(Week 24)
- Pain duration adolescent(Week 24)
- Pain intensity adolescent(Week 24)
- Quality of life adolescent self-assessment(Week 24)
- Quality of life adolescent external assessment(Week 24)
- Depression adolescent(Week 24)
- Stress adolescent(Week 24)
- Pain catastrophizing parents(Week 24)
- Quality of life parents(Week 24)
- Depression parents(Week 24)
- Stress parents(Week 24)
- Adverse events adolescent(Week 12)
- Adverse events parents(Week 12)
- Pain duration adolescent(Week 12)
- Pain intensity adolescent(Week 12)
- Quality of life adolescent self-assessment(Week 12)
- Quality of life adolescent external assessment(Week 12)
- Pain disability adolescent self-assessment(Week 12)
- Pain disability adolescent external assessment(Week 12)
- Pain coping adolescent(Week 12)
- Depression adolescent(Week 12)
- Stress adolescent(Week 12)
- Pain catastrophizing parents(Week 12)
- Quality of life parents(Week 12)
- Depression parents(Week 12)
- Stress parents(Week 12)
研究者
Holger Cramer
Research Director
Universität Duisburg-Essen