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临床试验/NCT04089618
NCT04089618已完成不适用

Meditation Based Lifestyle Modification in Chronic Pain

Diakonie Kliniken Zschadraß2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年9月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Pain VAS

研究概览

简要总结

MBLM is a holistic therapy for people with mental disorders whose feasibility positive effects on patients with depression have already been demonstrated in clinical application and a piloted study. In the present trial, the feasibility and effect of MBLM on patients with chronic pain will be investigated.

详细描述

MBLM expands existing concepts of mind-body medicine with ethical and spiritual concepts from the traditional Patanjali Yoga system, which can act as a coping factor on the one hand, and higher motivation and deepening of self-administered practice (mindfulness based exercises, body-oriented yoga exercises and mantra meditation). MBLM aims to establish an exercise routine in the daily lives of the participants, which leads to salutogenesis. The promotion of mental health through meditation and yoga has been well documented, also in clinical populations. The effects of meditation and yoga on addiction and pain are promising, but there is still a need for research. Furthermore, the preventive potential of the MBLM program will be examined for healthy volunteers, analogous to the already well-researched and widely used MBSR (Mindfulness Based Stress Reduction) program, which was originally also developed for patients with pain disorders.

The study will be conducted as an experimental single case analysis with multiple baseline design. Randomization takes place over time instead of control groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Outpatients
  • Current diagnosis of a chronic pain disorder.
  • Over 18 years old.
  • Physically able to perform simple yoga postures and sit for 20 minutes.
  • Have given your written consent to participate in the study.

排除标准

  • Psychotic symptoms
  • Acute suicidality
  • obsessive-compulsive disorder
  • Cerebro-organic diseases with clinically relevant symptoms
  • Severe multimorbidity
  • Current participation in another meditation or yoga study
  • Regular meditation or yoga practice (> once a week in the last 6 months)

结局指标

主要结局

Pain VAS

时间窗: through study completion, daily for around 3 months

Visual Analog Scale for Pain

Pain medication

时间窗: through study completion, daily for around 3 months

Use of pain medication

Well-Being

时间窗: through study completion, daily for around 3 months

The WHO-5 Well-Being Scale (WHO-5; World Health Organisation, 1998)

次要结局

  • Pain Self Efficacy(through study completion, weekly for around 3 months)
  • Emotion Regulation(through study completion, weekly for around 3 months)
  • Depression, Anxiety & Stress(through study completion, weekly for around 3 months)
  • Body awareness(through study completion, twice weekly for around 3 months)
  • Mind-Wandering(through study completion, weekly for around 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Holger C. Bringmann

Principal investigator

Charite University, Berlin, Germany

研究点 (2)

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