Effects of Yoga and Relaxation on Stress and Quality of Life

Study Overview
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Brief Summary
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The aim of this study is to measure the effects of three stress reduction methods on patients with stress and stress associated complaints.

Official Title
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Effects of Yoga and Relaxation on Stress and Quality of Life - a Three-armed Randomized Controlled Study

Conditions
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Stress, Psychological

Intervention / Treatment
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* Behavioral: Integrative Yoga
* Behavioral: Iyengar Yoga
* Behavioral: Mindfulness


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrative Yoga<br>A 12-week Integrative Yoga intervention which has meditative and psycho-educational components corresponding to traditional yoga practice. | Behavioral: Integrative Yoga<br>* A 12-week Integrative Yoga intervention which has meditative and psycho-educational components corresponding to traditional yoga practice.<br>|
| Active Comparator: Iyengar yoga<br>A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga). | Behavioral: Iyengar Yoga<br>* A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga).<br>|
| Active Comparator: Mindfulness<br>A 12-week mindfulness intervention designed for the healthy handling of stress. | Behavioral: Mindfulness<br>* A 12-week mindfulness intervention designed for the healthy handling of stress.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress questionnaire (Cohen Perceived Stress Scale, CPSS) | 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. | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Outcomes Study Short Form Quality of Life (MOS SF-36) | Assessing full scale, range 0-100, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Hospital Anxiety and Depression Scale (HADS) | Assessing full scale, range 0-42, lower score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Zerssen symptom list (B-LR and B-LR') | Assessing full scale, range 20-80, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| International Physical Activity Questionnaire (IPAQ) | 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. | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Maslach Burnout Inventory (MBI) | Assessing full scale, range 0-96, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA) | Assessing full scale, range 0-56, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Aspects of Spirituality (ASP) | Assessing full scale, range 0-112, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Self-Regulation | Assessing full scale, range 16-96, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Multidimensional Assessment of Interoceptive Awareness (MAIA) | Assessing full scale, range 0-160, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Trauma symptoms (Posttraumatic Checklist, PCL-5) | Assessing full scale, range 0-80, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Mysticism Scale Short Form | Assessing full scale, range 0-32, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Numerical Analog Scales | Assessing stress, back pain, headache, shoulder/neck tension, sleep quality, exhaustion, nervousness, digestive complaints, mood on 0-11 points each. | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Expectation questions | For intervention 1, intervention 2 and intervention 3 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all) | Date of inclusion (baseline) | 
| Evaluation questions | For intervention 1, intervention 2 and intervention 3 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all) | After 12 weeks, after 24 weeks | 
| Bio-electrical Impedance Analysis (BIA) | Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Dietary Behaviour assessed by Food Frequency Questionaire (Gesundheit Erwachsener in Deutschland, DEGS) | Quantitative description of nutritional habits | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Medication intake | Name of medication and dosage | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Heart Rate Variability (HRV) | 24h measuring by Faros 180 (chest) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Sociodemographic Measurements | 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 | Date of inclusion (baseline) | 
| Behavioral questions: alcohol consumption | Number of alcoholic beverages on average per week in the last month | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Behavioral questions: relaxation | Relaxation behavior on average per week in the last month in minutes | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Behavioral questions: cigarettes | Number of cigarettes on average per week in the last month in minutes | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Electrodermal Activity (Galvanic Skin Response) | 24h measuring by Biovotion Everion device | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Blood Volume Pulse | 24h measuring by Biovotion Everion device | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Respiration Rate | 24h measuring by Biovotion Everion device | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Interbeat Interval (IBI) | 24h measuring by Biovotion Everion device | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Heart Rate (HR) | 24h measuring by Faros 180 (chest), Biovotion Everion | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Skin Temperature | 24h measuring by Biovotion Everion device | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Blood Oxygenization | 24h measuring by Biovotion Everion device | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Body weight (kg) | 24h measuring by Biovotion Everion device | 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 | 
| Waist circumference (cm) |  | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yoga, Meditation, Progressive muscle relaxation, Stress, Education