Meditation Based Lifestyle Modification in Chronic Pain (MBLM-P)
Primary Purpose
Pain, Chronic
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
MBLM
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Chronic focused on measuring Yoga, Meditation, Yoga Philosophy, Mantra, Mind-Body
Eligibility Criteria
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)
Sites / Locations
- Diakoniekliniken Zschadraß
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Baseline 10 Days
Baseline 17 Days
Baseline 24 Days
Arm Description
10 days baseline before intervention starts.
17 days baseline before intervention starts.
24 days baseline before intervention starts.
Outcomes
Primary Outcome Measures
Pain VAS
Visual Analog Scale for Pain
Pain medication
Use of pain medication
Well-Being
The WHO-5 Well-Being Scale (WHO-5; World Health Organisation, 1998)
Secondary Outcome Measures
Emotion Regulation
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2003)
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)
Mind-Wandering
a) Mind-Wandering Questionnaire (MWQ; Mrazek, Phillips, Franklin, Broadway, & Schooler, 2013)
Depression, Anxiety & Stress
DASS (Nilges & Essau, 2015)
Pain Self Efficacy
PAIN SELF EFFICACY QUESTIONNAIRE (PSEQ) M.K.Nicholas (1989)
Full Information
NCT ID
NCT04089618
First Posted
September 7, 2019
Last Updated
July 27, 2020
Sponsor
Diakonie Kliniken Zschadraß
Collaborators
Chemnitz University of Technology, Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT04089618
Brief Title
Meditation Based Lifestyle Modification in Chronic Pain
Acronym
MBLM-P
Official Title
Meditation Based Lifestyle Modification in Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diakonie Kliniken Zschadraß
Collaborators
Chemnitz University of Technology, Technische Universität Dresden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
Keywords
Yoga, Meditation, Yoga Philosophy, Mantra, Mind-Body
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Baseline 10 Days
Arm Type
Experimental
Arm Description
10 days baseline before intervention starts.
Arm Title
Baseline 17 Days
Arm Type
Experimental
Arm Description
17 days baseline before intervention starts.
Arm Title
Baseline 24 Days
Arm Type
Experimental
Arm Description
24 days baseline before intervention starts.
Intervention Type
Behavioral
Intervention Name(s)
MBLM
Intervention Description
Complex 8 week Mind-Body program.
Primary Outcome Measure Information:
Title
Pain VAS
Description
Visual Analog Scale for Pain
Time Frame
through study completion, daily for around 3 months
Title
Pain medication
Description
Use of pain medication
Time Frame
through study completion, daily for around 3 months
Title
Well-Being
Description
The WHO-5 Well-Being Scale (WHO-5; World Health Organisation, 1998)
Time Frame
through study completion, daily for around 3 months
Secondary Outcome Measure Information:
Title
Emotion Regulation
Description
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2003)
Time Frame
through study completion, weekly for around 3 months
Title
Body awareness
Description
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)
Time Frame
through study completion, twice weekly for around 3 months
Title
Mind-Wandering
Description
a) Mind-Wandering Questionnaire (MWQ; Mrazek, Phillips, Franklin, Broadway, & Schooler, 2013)
Time Frame
through study completion, weekly for around 3 months
Title
Depression, Anxiety & Stress
Description
DASS (Nilges & Essau, 2015)
Time Frame
through study completion, weekly for around 3 months
Title
Pain Self Efficacy
Description
PAIN SELF EFFICACY QUESTIONNAIRE (PSEQ) M.K.Nicholas (1989)
Time Frame
through study completion, weekly for around 3 months
Other Pre-specified Outcome Measures:
Title
Quality of Life
Description
WHOQol-BREF
Time Frame
at week 0 and week 11
Title
Chronic Pain Self-Efficacy
Description
CPSS (Anderson et al, 1995)
Time Frame
at week 0 and week 11
Title
Distress Tolerance
Description
Distress tolerance (Simons & Gaher, 2005)
Time Frame
at week 0 and week 11
Title
Spiritual and Religious Attitudes in Dealing with Illness
Description
SpREUK (Büssing A., 2010)
Time Frame
at week 0 and week 11
Title
Trigunas - Emotion, Cognition and Health Behaviour
Description
TGS Subscales (Puta & Sedlmeier, 2014)
Time Frame
at week 0 and week 11
Title
Illness Cognition
Description
Illness Cognition Questionnaire for Chronic Diseases (Evers et al., 2001)
Time Frame
at week 0 and week 11
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Diakoniekliniken Zschadraß
City
Colditz
State/Province
Sachsen
ZIP/Postal Code
04680
Country
Germany
12. IPD Sharing Statement
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Meditation Based Lifestyle Modification in Chronic Pain
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