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临床试验/NCT06431087
NCT06431087招募中不适用

Effect of a Mindfulnes Program "Healthy Under Stress" on Stress and Stress-associated Parameters: A Prospective Intervention Study

University Hospital Tuebingen1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年7月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Perceived Stress Scale

研究概览

简要总结

Stress describes a state of worry and mental tension that results from an imbalance between demands and coping strategies, as well as the disruption of physiological homeostasis. It represents an important ability to adapt to environmental factors, and chronically has negative psychological and physical consequences. The mind-body medical program "Healthy in Stress" according to Esch aims to strengthen the individual's ability to deal with stress through comprehensive training. The main target parameter is stress reduction, measured using the Perceived Stress Scale (PSS).

详细描述

After baseline (t0), all participant will receive the following intervention:

The intervention lasts eight weeks, with a two-hour session held once a week. The selected topics include nutrition, mindfulness, exercise, relaxation techniques, dealing with stressors, effective communication and the promotion of a supportive social network.

t1 (at the end of the program).

t2 (3 months after t0).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Employees, patients and family members of the Robert-Bosch-Krankenhaus (RBK) and Bosch Health Campus of all specialties.
  • Informed consent.

排除标准

  • Physical or mental condition which, in the opinion of the investigator does not allow the patient to participate in the study.
  • Participation in other clinical studies with behavioral, psychological or complementary medical interventions.
  • Insufficient knowledge of the German language.

研究组 & 干预措施

Mindfulnes "Healthy Under Stress" Stress Management Program

Experimental

Participants will have two-hour sessions for 8 weeks.

干预措施: Mindfulness course (Other)

结局指标

主要结局

Perceived Stress Scale

时间窗: After 8 Weeks (end of intervention)

The Perceived Stress Scale (PSS-10) is a scale records patients' subjective stress in the last month in four subscales: worries, anxiety, happiness and needs). Ten items are rating on a five-point scale (1 = never, 5 = very often).

次要结局

  • Hospital Anxiety and Depression Scale(Follow-up 3 Moths after the intervention)
  • Perceived Stress Scale(Follow-up 3 Moths after the intervention)
  • International Physical Activity Questionnaire(Follow-up 3 Moths after the intervention)
  • Mindful Attention and Awareness Scale(Follow-up 3 Moths after the intervention)
  • Quality of life Questionnaire(Follow-up 3 Moths after the intervention)
  • Mediterranean Diet Adhrence Screener(Follow-up 3 Moths after the intervention)
  • Safety evaluation(After 8 Weeks (end of intervention))
  • Hospital Anxiety and Depression Scale(After 8 Weeks (end of intervention))
  • Quality of life Questionnaire(After 8 Weeks (end of intervention))
  • International Physical Activity Questionnaire(After 8 Weeks (end of intervention))
  • Mediterranean Diet Adhrence Screener(After 8 Weeks (end of intervention))
  • Mindful Attention and Awareness Scale(After 8 Weeks (end of intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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