Meditation Based Lifestyle Modification in Chronic Pain

NCT ID: NCT04089618

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-02

Study Completion Date

2020-01-31

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.

Conditions

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Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Baseline 10 Days

10 days baseline before intervention starts.

Group Type EXPERIMENTAL

MBLM

Intervention Type BEHAVIORAL

Complex 8 week Mind-Body program.

Baseline 17 Days

17 days baseline before intervention starts.

Group Type EXPERIMENTAL

MBLM

Intervention Type BEHAVIORAL

Complex 8 week Mind-Body program.

Baseline 24 Days

24 days baseline before intervention starts.

Group Type EXPERIMENTAL

MBLM

Intervention Type BEHAVIORAL

Complex 8 week Mind-Body program.

Interventions

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MBLM

Complex 8 week Mind-Body program.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chemnitz University of Technology

OTHER

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role collaborator

Diakonie Kliniken Zschadraß

OTHER

Sponsor Role lead

Responsible Party

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Holger C. Bringmann

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Diakoniekliniken Zschadraß

Colditz, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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MBLM-P

Identifier Type: -

Identifier Source: org_study_id

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