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Completed

NCT Number: NCT04039074

Effects of Yoga and Relaxation on Stress and Quality of Life

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

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, 14109, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrative Yoga

Behavioral

A 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice.

Iyengar Yoga

Behavioral

A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga).

Mindfulness

Behavioral

A 12-week mindfulness intervention designed for the healthy handling of stress.

Primary outcomes

  1. 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

  1. Medical Outcomes Study Short Form Quality of Life (MOS SF-36)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Assessing full scale, range 0-100, higher score meaning a better outcome

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Assessing full scale, range 0-42, lower score meaning a better outcome

  3. Zerssen symptom list (B-LR and B-LR')

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Assessing full scale, range 20-80, higher score meaning a better outcome

  4. International Physical Activity Questionnaire (IPAQ)

    Time frame: 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.

  5. Maslach Burnout Inventory (MBI)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Assessing full scale, range 0-96, higher score meaning a better outcome

  6. Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Assessing full scale, range 0-56, higher score meaning a better outcome

  7. Aspects of Spirituality (ASP)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Assessing full scale, range 0-112, higher score meaning a better outcome

  8. Self-Regulation

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Assessing full scale, range 16-96, higher score meaning a better outcome

  9. Multidimensional Assessment of Interoceptive Awareness (MAIA)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Assessing full scale, range 0-160, higher score meaning a better outcome

  10. Trauma symptoms (Posttraumatic Checklist, PCL-5)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Assessing full scale, range 0-80, higher score meaning a better outcome

  11. Mysticism Scale Short Form

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Assessing full scale, range 0-32, higher score meaning a better outcome

  12. Numerical Analog Scales

    Time frame: 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.

  13. Expectation questions

    Time frame: 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)

  14. Evaluation questions

    Time frame: 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)

  15. Bio-electrical Impedance Analysis (BIA)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg)

  16. Dietary Behaviour assessed by Food Frequency Questionaire (Gesundheit Erwachsener in Deutschland, DEGS)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Quantitative description of nutritional habits

  17. Medication intake

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Name of medication and dosage

  18. Heart Rate Variability (HRV)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    24h measuring by Faros 180 (chest)

  19. Sociodemographic Measurements

    Time frame: 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

  20. Behavioral questions: alcohol consumption

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Number of alcoholic beverages on average per week in the last month

  21. Behavioral questions: relaxation

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Relaxation behavior on average per week in the last month in minutes

  22. Behavioral questions: cigarettes

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    Number of cigarettes on average per week in the last month in minutes

  23. Electrodermal Activity (Galvanic Skin Response)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    24h measuring by Biovotion Everion device

  24. Blood Volume Pulse

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    24h measuring by Biovotion Everion device

  25. Respiration Rate

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    24h measuring by Biovotion Everion device

  26. Interbeat Interval (IBI)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    24h measuring by Biovotion Everion device

  27. Heart Rate (HR)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    24h measuring by Faros 180 (chest), Biovotion Everion

  28. Skin Temperature

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    24h measuring by Biovotion Everion device

  29. Blood Oxygenization

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    24h measuring by Biovotion Everion device

  30. Body weight (kg)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    24h measuring by Biovotion Everion device

  31. Body Mass Index (kg/m2)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

  32. Waist circumference (cm)

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

Other outcomes

  1. Qualitative interviews in focus groups interviews

    Time frame: 12 weeks after inclusion

    Qualitative assessment will be carried out in 45-minute focus group interviews in 12 (randomized selected) patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 31, 2019
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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