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Meditation Based Lifestyle Modification in Chronic Pain

Meditation Based Lifestyle Modification in Chronic Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04089618
Acronym
MBLM-P
Enrollment
22
Registered
2019-09-13
Start date
2019-09-02
Completion date
2020-01-31
Last updated
2020-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Chronic

Keywords

Yoga, Meditation, Yoga Philosophy, Mantra, Mind-Body

Brief summary

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

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.

Interventions

BEHAVIORALMBLM

Complex 8 week Mind-Body program.

Sponsors

Chemnitz University of Technology
CollaboratorOTHER
Technische Universität Dresden
CollaboratorOTHER
Diakonie Kliniken Zschadraß
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Outpatients 2. Current diagnosis of a chronic pain disorder. 3. Over 18 years old. 4. Physically able to perform simple yoga postures and sit for 20 minutes. 5. Have given your written consent to participate in the study.

Exclusion criteria

1. Psychotic symptoms 2. Acute suicidality 3. obsessive-compulsive disorder 4. Cerebro-organic diseases with clinically relevant symptoms 5. Severe multimorbidity 6. Current participation in another meditation or yoga study 7. Regular meditation or yoga practice (\> once a week in the last 6 months)

Design outcomes

Primary

MeasureTime frameDescription
Pain VASthrough study completion, daily for around 3 monthsVisual Analog Scale for Pain
Well-Beingthrough study completion, daily for around 3 monthsThe WHO-5 Well-Being Scale (WHO-5; World Health Organisation, 1998)
Pain medicationthrough study completion, daily for around 3 monthsUse of pain medication

Secondary

MeasureTime frameDescription
Mind-Wanderingthrough study completion, weekly for around 3 monthsa) Mind-Wandering Questionnaire (MWQ; Mrazek, Phillips, Franklin, Broadway, & Schooler, 2013)
Body awarenessthrough study completion, twice weekly for around 3 monthsadapted 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)
Emotion Regulationthrough study completion, weekly for around 3 monthsDifficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2003)
Depression, Anxiety & Stressthrough study completion, weekly for around 3 monthsDASS (Nilges & Essau, 2015)
Pain Self Efficacythrough study completion, weekly for around 3 monthsPAIN SELF EFFICACY QUESTIONNAIRE (PSEQ) M.K.Nicholas (1989)

Other

MeasureTime frameDescription
Spiritual and Religious Attitudes in Dealing with Illnessat week 0 and week 11SpREUK (Büssing A., 2010)
Distress Toleranceat week 0 and week 11Distress tolerance (Simons & Gaher, 2005)
Trigunas - Emotion, Cognition and Health Behaviourat week 0 and week 11TGS Subscales (Puta & Sedlmeier, 2014)
Illness Cognitionat week 0 and week 11Illness Cognition Questionnaire for Chronic Diseases (Evers et al., 2001)
Chronic Pain Self-Efficacyat week 0 and week 11CPSS (Anderson et al, 1995)
Quality of Lifeat week 0 and week 11WHOQol-BREF

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026