Meditation Based Lifestyle Modification in Chronic Pain

Study Overview
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Brief Summary
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MBLM is a holistic therapy for people with mental disorders whose feasibility positive effects on patients with depression have already been demonstrated in clinical application and a piloted study. In the present trial, the feasibility and effect of MBLM on patients with chronic pain will be investigated.

Detailed Description
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MBLM expands existing concepts of mind-body medicine with ethical and spiritual concepts from the traditional Patanjali Yoga system, which can act as a coping factor on the one hand, and higher motivation and deepening of self-administered practice (mindfulness based exercises, body-oriented yoga exercises and mantra meditation). MBLM aims to establish an exercise routine in the daily lives of the participants, which leads to salutogenesis. The promotion of mental health through meditation and yoga has been well documented, also in clinical populations. The effects of meditation and yoga on addiction and pain are promising, but there is still a need for research. Furthermore, the preventive potential of the MBLM program will be examined for healthy volunteers, analogous to the already well-researched and widely used MBSR (Mindfulness Based Stress Reduction) program, which was originally also developed for patients with pain disorders. The study will be conducted as an experimental single case analysis with multiple baseline design. Randomization takes place over time instead of control groups.

Official Title
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Meditation Based Lifestyle Modification in Chronic Pain

Conditions
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Pain, Chronic

Intervention / Treatment
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* Behavioral: MBLM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients Current diagnosis of a chronic pain disorder. Over 18 years old. Physically able to perform simple yoga postures and sit for 20 minutes. Have given your written consent to participate in the study. Exclusion Criteria: Psychotic symptoms Acute suicidality obsessive-compulsive disorder Cerebro-organic diseases with clinically relevant symptoms Severe multimorbidity Current participation in another meditation or yoga study Regular meditation or yoga practice (> once a week in the last 6 months)

Ages Eligible for Study
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Minimum Age: 18 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: Single Group Assignment
Interventional Model Description: Single Case Research (SCR), also known as single case experimenal design (SCED). This is a reserach methodology using a single unit of analysis and characterized by repeated measures over time.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baseline 10 Days<br>10 days baseline before intervention starts. | Behavioral: MBLM<br>* Complex 8 week Mind-Body program.<br>|
| Experimental: Baseline 17 Days<br>17 days baseline before intervention starts. | Behavioral: MBLM<br>* Complex 8 week Mind-Body program.<br>|
| Experimental: Baseline 24 Days<br>24 days baseline before intervention starts. | Behavioral: MBLM<br>* Complex 8 week Mind-Body program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain VAS | Visual Analog Scale for Pain | through study completion, daily for around 3 months | 
| Pain medication | Use of pain medication | through study completion, daily for around 3 months | 
| Well-Being | The WHO-5 Well-Being Scale (WHO-5; World Health Organisation, 1998) | through study completion, daily for around 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion Regulation | Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2003) | through study completion, weekly for around 3 months | 
| Body awareness | adapted from Private-Body-Consciousness-Scale (PBCS; Miller, Murphy, & Buss, 1981), Body-Awareness-Questionnaire (BAQ; Shields, Mallory & Simon, 1989) and Multidimensional Assessment of Interoceptive Awareness (MAIA; Mehling et al., 2012) | through study completion, twice weekly for around 3 months | 
| Mind-Wandering | a) Mind-Wandering Questionnaire (MWQ; Mrazek, Phillips, Franklin, Broadway, & Schooler, 2013) | through study completion, weekly for around 3 months | 
| Depression, Anxiety & Stress | DASS (Nilges & Essau, 2015) | through study completion, weekly for around 3 months | 
| Pain Self Efficacy | PAIN SELF EFFICACY QUESTIONNAIRE (PSEQ) M.K.Nicholas (1989) | through study completion, weekly for around 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yoga, Meditation, Yoga Philosophy, Mantra, Mind-Body