Clinical trial NCT04089618: Meditation Based Lifestyle Modification in Chronic Pain
Official title: Meditation Based Lifestyle Modification in Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Keywords: Yoga
Meditation
Yoga Philosophy
Mantra
Mind-Body
Lead sponsor: Diakonie Kliniken Zschadraß
Sponsor class: OTHER
Collaborators: name: Chemnitz University of Technology
name: Technische Universität Dresden
First posted: 2019-09-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain VAS
timeFrame: through study completion, daily for around 3 months
measure: Pain medication
timeFrame: through study completion, daily for around 3 months
measure: Well-Being
timeFrame: through study completion, daily for around 3 months
Secondary outcomes:
measure: Emotion Regulation
timeFrame: through study completion, weekly for around 3 months
measure: Body awareness
timeFrame: through study completion, twice weekly for around 3 months
measure: Mind-Wandering
timeFrame: through study completion, weekly for around 3 months
measure: Depression, Anxiety & Stress
timeFrame: through study completion, weekly for around 3 months
measure: Pain Self Efficacy
timeFrame: through study completion, weekly for around 3 months
Other outcomes:
measure: Quality of Life
timeFrame: at week 0 and week 11
measure: Chronic Pain Self-Efficacy
timeFrame: at week 0 and week 11
measure: Distress Tolerance
timeFrame: at week 0 and week 11
measure: Spiritual and Religious Attitudes in Dealing with Illness
timeFrame: at week 0 and week 11
measure: Trigunas - Emotion, Cognition and Health Behaviour
timeFrame: at week 0 and week 11
measure: Illness Cognition
timeFrame: at week 0 and week 11
Locations:
city: Colditz
country: Germany
facility: Diakoniekliniken Zschadraß
state: Sachsen
Study officials:
References: