Effects of Yoga and Relaxation on Stress and Quality of Life
- Conditions
- Stress, Psychological
- Interventions
- Behavioral: MindfulnessBehavioral: Integrative YogaBehavioral: Iyengar Yoga
- Registration Number
- NCT04039074
- Lead Sponsor
- Charite University, Berlin, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindfulness Mindfulness A 12-week mindfulness intervention designed for the healthy handling of stress. Integrative Yoga Integrative Yoga A 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice. Iyengar yoga Iyengar Yoga A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga).
- Primary Outcome Measures
Name Time Method Stress questionnaire (Cohen Perceived Stress Scale, CPSS) 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 Outcome Measures
Name Time Method Waist circumference (cm) 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 Multidimensional Assessment of Interoceptive Awareness (MAIA) Date of inclusion (baseline), after 12 weeks, after 24 weeks Assessing full scale, range 0-160, higher score meaning a better outcome
Zerssen symptom list (B-LR and B-LR') Date of inclusion (baseline), after 12 weeks, after 24 weeks Assessing full scale, range 20-80, higher score meaning a better outcome
Aspects of Spirituality (ASP) Date of inclusion (baseline), after 12 weeks, after 24 weeks Assessing full scale, range 0-112, higher score meaning a better outcome
Hospital Anxiety and Depression Scale (HADS) Date of inclusion (baseline), after 12 weeks, after 24 weeks Assessing full scale, range 0-42, lower score meaning a better outcome
Self-Regulation Date of inclusion (baseline), after 12 weeks, after 24 weeks Assessing full scale, range 16-96, higher score meaning a better outcome
Evaluation questions After 12 weeks, after 24 weeks For intervention 1, intervention 2 and intervention 3 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all)
Numerical Analog Scales Date of inclusion (baseline), after 12 weeks, after 24 weeks Assessing stress, back pain, headache, shoulder/neck tension, sleep quality, exhaustion, nervousness, digestive complaints, mood on 0-11 points each.
Mysticism Scale Short Form Date of inclusion (baseline), after 12 weeks, after 24 weeks Assessing full scale, range 0-32, higher score meaning a better outcome
Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA) Date of inclusion (baseline), after 12 weeks, after 24 weeks Assessing full scale, range 0-56, higher score meaning a better outcome
Expectation questions Date of inclusion (baseline) For intervention 1, intervention 2 and intervention 3 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all)
Bio-electrical Impedance Analysis (BIA) Date of inclusion (baseline), after 12 weeks, after 24 weeks Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg)
Dietary Behaviour assessed by Food Frequency Questionaire (Gesundheit Erwachsener in Deutschland, DEGS) Date of inclusion (baseline), after 12 weeks, after 24 weeks Quantitative description of nutritional habits
Heart Rate Variability (HRV) Date of inclusion (baseline), after 12 weeks, after 24 weeks 24h measuring by Faros 180 (chest)
Medication intake Date of inclusion (baseline), after 12 weeks, after 24 weeks Name of medication and dosage
Sociodemographic Measurements Date of inclusion (baseline) Age, gender, education level, household income, employment status, marital status, language spoken, complete family history, current and previous illness and co-morbidities, and current medications
Behavioral questions: cigarettes Date of inclusion (baseline), after 12 weeks, after 24 weeks Number of cigarettes on average per week in the last month in minutes
Electrodermal Activity (Galvanic Skin Response) Date of inclusion (baseline), after 12 weeks, after 24 weeks 24h measuring by Biovotion Everion device
Skin Temperature Date of inclusion (baseline), after 12 weeks, after 24 weeks 24h measuring by Biovotion Everion device
Medical Outcomes Study Short Form Quality of Life (MOS SF-36) Date of inclusion (baseline), after 12 weeks, after 24 weeks Assessing full scale, range 0-100, higher score meaning a better outcome
International Physical Activity Questionnaire (IPAQ) Date of inclusion (baseline), after 12 weeks, after 24 weeks MET minutes represent the amount of energy expended carrying out physical activity. To get a continuous variable score from the IPAQ (MET minutes a week) we will consider walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS.
Maslach Burnout Inventory (MBI) Date of inclusion (baseline), after 12 weeks, after 24 weeks Assessing full scale, range 0-96, higher score meaning a better outcome
Trauma symptoms (Posttraumatic Checklist, PCL-5) Date of inclusion (baseline), after 12 weeks, after 24 weeks Assessing full scale, range 0-80, higher score meaning a better outcome
Blood Volume Pulse Date of inclusion (baseline), after 12 weeks, after 24 weeks 24h measuring by Biovotion Everion device
Respiration Rate Date of inclusion (baseline), after 12 weeks, after 24 weeks 24h measuring by Biovotion Everion device
Heart Rate (HR) Date of inclusion (baseline), after 12 weeks, after 24 weeks 24h measuring by Faros 180 (chest), Biovotion Everion
Behavioral questions: relaxation Date of inclusion (baseline), after 12 weeks, after 24 weeks Relaxation behavior on average per week in the last month in minutes
Blood Oxygenization Date of inclusion (baseline), after 12 weeks, after 24 weeks 24h measuring by Biovotion Everion device
Behavioral questions: alcohol consumption Date of inclusion (baseline), after 12 weeks, after 24 weeks Number of alcoholic beverages on average per week in the last month
Interbeat Interval (IBI) Date of inclusion (baseline), after 12 weeks, after 24 weeks 24h measuring by Biovotion Everion device
Body weight (kg) Date of inclusion (baseline), after 12 weeks, after 24 weeks 24h measuring by Biovotion Everion device
Trial Locations
- Locations (1)
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
🇩🇪Berlin, Germany