Clinical trial NCT04039074: Effects of Yoga and Relaxation on Stress and Quality of Life
Official title: Effects of Yoga and Relaxation on Stress and Quality of Life - a Three-armed Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: Yoga
Meditation
Progressive muscle relaxation
Stress
Education
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Secondary outcomes:
measure: Medical Outcomes Study Short Form Quality of Life (MOS SF-36)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Zerssen symptom list (B-LR and B-LR')
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Maslach Burnout Inventory (MBI)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Aspects of Spirituality (ASP)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Self-Regulation
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Trauma symptoms (Posttraumatic Checklist, PCL-5)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Mysticism Scale Short Form
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Numerical Analog Scales
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Expectation questions
timeFrame: Date of inclusion (baseline)
measure: Evaluation questions
timeFrame: After 12 weeks, after 24 weeks
measure: Bio-electrical Impedance Analysis (BIA)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Dietary Behaviour assessed by Food Frequency Questionaire (Gesundheit Erwachsener in Deutschland, DEGS)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Medication intake
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Heart Rate Variability (HRV)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Sociodemographic Measurements
timeFrame: Date of inclusion (baseline)
measure: Behavioral questions: alcohol consumption
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Behavioral questions: relaxation
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Behavioral questions: cigarettes
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Electrodermal Activity (Galvanic Skin Response)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Blood Volume Pulse
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Respiration Rate
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Interbeat Interval (IBI)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Heart Rate (HR)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Skin Temperature
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Blood Oxygenization
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Body weight (kg)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Body Mass Index (kg/m2)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Waist circumference (cm)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Other outcomes:
measure: Qualitative interviews in focus groups interviews
timeFrame: 12 weeks after inclusion
Locations:
city: Berlin
country: Germany
facility: Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Study officials:
affiliation: Charite - Universitätsmedizin Berlin
name: Andreas Michalsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: