NCT04039074CompletedNot Applicable
Effects of Yoga and Relaxation on Stress and Quality of Life - a Three-armed Randomized Controlled Study
Charite University, Berlin, Germany2 sites in 1 country102 target enrollmentStarted: July 29, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
Study Overview
Brief Summary
The aim of this study is to measure the effects of three stress reduction methods on patients with stress and stress associated complaints.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •stress with at least 4 of 10 points on the Numeric Analogue Scale (NAS) at least 1 month and at least 3 of the following 8 stress symptoms: sleep disorder, inappetence or increased appetite, shoulder neck tension/back pain, tension headache, concentration disorder, exhaustion, nervousness/irritability, stress-associated digestive problems
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 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.
Secondary Outcomes
- Multidimensional Assessment of Interoceptive Awareness (MAIA)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Zerssen symptom list (B-LR and B-LR')(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Aspects of Spirituality (ASP)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Hospital Anxiety and Depression Scale (HADS)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Self-Regulation(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Evaluation questions(After 12 weeks, after 24 weeks)
- Numerical Analog Scales(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Mysticism Scale Short Form(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Expectation questions(Date of inclusion (baseline))
- Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Bio-electrical Impedance Analysis (BIA)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Dietary Behaviour assessed by Food Frequency Questionaire (Gesundheit Erwachsener in Deutschland, DEGS)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Heart Rate Variability (HRV)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Medication intake(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Sociodemographic Measurements(Date of inclusion (baseline))
- Behavioral questions: cigarettes(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Electrodermal Activity (Galvanic Skin Response)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Skin Temperature(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Medical Outcomes Study Short Form Quality of Life (MOS SF-36)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- International Physical Activity Questionnaire (IPAQ)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Maslach Burnout Inventory (MBI)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Trauma symptoms (Posttraumatic Checklist, PCL-5)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Blood Volume Pulse(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Respiration Rate(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Heart Rate (HR)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Body Mass Index (kg/m2)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Behavioral questions: relaxation(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Blood Oxygenization(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Behavioral questions: alcohol consumption(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Interbeat Interval (IBI)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Body weight (kg)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Waist circumference (cm)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
Investigators
Andreas Michalsen
Prof. Dr. med.
Charite University, Berlin, Germany
Study Sites (2)
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