NCT04780646招募中不适用
Effects of Urban Nature on Stress and Quality of Life of Subjects With Elevated Stress Levels - a Three-armed Randomized Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
研究概览
简要总结
The aim of this study is to investigate the effects of regular nature therapy in urban nature with guidance of a licensed nature therapist on stress, quality of life and physical symptoms of subjects with elevated stress levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stress with at least 4 of 10 points on the Numeric Analogue Scale (NAS) at least 1 month
- •at least 3 of the following 8 stress-associated symptoms: sleep disturbances, inappetence or increased appetite, shoulder neck tension/back pain, tension headache, concentration disturbances, exhaustion, nervousness/irritability, stress-associated digestive complaints.
排除标准
- •serious acute or chronic diseases
- •pregnancy or lactation
- •known serious mental illness
- •immobility or restriction for gymnastics exercises due to orthopaedic, neurological or other medical cause
- •participation in another study
结局指标
主要结局
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
时间窗: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Change from Baseline in the CPSS, range from 0 to 4 in each item. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the positively stated items and then summing across all scale items while higher values meaning a higher grade of perceived stress.
次要结局
- Zerssen symptom list (B-LR and B-LR')(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- International Physical Activity Questionnaire (IPAQ)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- Sociodemographic Measurements(Date of Inclusion (Baseline))
- General Self-Efficacy Short Scale-3 (GSE-3)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- Perceived Benefits of Nature Questionnaire (PBNQ)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- Profile of Mood States (POMS)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- Behavioural questions: doctor visits and health(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- Expectation questions(Date of Inclusion (Baseline))
- Behavioural questions: cigarette consumption(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- Heart Rate (HR)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
- Maslach Burnout Inventory (MBI)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- Flourishing Scale (FS)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- Behavioural questions: alcohol consumption(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- Subjective Vitality Scale (SVS-G state)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- Hospital Anxiety and Depression Scale (HADS)(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- Behavioural questions: time in nature(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- Behavioural questions: nature as priority(Date of Inclusion (Baseline), after 8 weeks and after 16 weeks)
- Heart Rate Variability (HRV)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
研究者
Andreas Michalsen
Prof. Dr.
Charite University, Berlin, Germany
研究点 (2)
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