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Meditation Based Lifestyle Modification in Chronic Pain

Not Applicable
Completed
Conditions
Pain, Chronic
Interventions
Behavioral: MBLM
Registration Number
NCT04089618
Lead Sponsor
Diakonie Kliniken Zschadraß
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
22
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Baseline 24 DaysMBLM24 days baseline before intervention starts.
Baseline 17 DaysMBLM17 days baseline before intervention starts.
Baseline 10 DaysMBLM10 days baseline before intervention starts.
Primary Outcome Measures
NameTimeMethod
Pain VASthrough study completion, daily for around 3 months

Visual Analog Scale for Pain

Pain medicationthrough study completion, daily for around 3 months

Use of pain medication

Well-Beingthrough study completion, daily for around 3 months

The WHO-5 Well-Being Scale (WHO-5; World Health Organisation, 1998)

Secondary Outcome Measures
NameTimeMethod
Pain Self Efficacythrough study completion, weekly for around 3 months

PAIN SELF EFFICACY QUESTIONNAIRE (PSEQ) M.K.Nicholas (1989)

Emotion Regulationthrough study completion, weekly for around 3 months

Difficulties in Emotion Regulation Scale (DERS; Gratz \& Roemer, 2003)

Depression, Anxiety & Stressthrough study completion, weekly for around 3 months

DASS (Nilges \& Essau, 2015)

Body awarenessthrough study completion, twice weekly for around 3 months

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)

Mind-Wanderingthrough study completion, weekly for around 3 months

a) Mind-Wandering Questionnaire (MWQ; Mrazek, Phillips, Franklin, Broadway, \& Schooler, 2013)

Trial Locations

Locations (1)

Diakoniekliniken Zschadraß

🇩🇪

Colditz, Sachsen, Germany

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