Meditation Based Lifestyle Modification in Chronic Pain

NCT04089618 | Completed

• 1 other identifier: MBLM-P
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic

Keywords

Yoga; Meditation; Yoga Philosophy; Mantra; Mind-Body

Outcome Measures

Primary Outcomes (3)

• Pain VAS

  Visual Analog Scale for Pain

  through study completion, daily for around 3 months

• Pain medication

  Use of pain medication

  through study completion, daily for around 3 months

• Well-Being

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

  through study completion, daily for around 3 months

Secondary Outcomes (5)

• Emotion Regulation

  through study completion, weekly for around 3 months

• Body awareness

  through study completion, twice weekly for around 3 months

• Mind-Wandering

  through study completion, weekly for around 3 months

• Depression, Anxiety & Stress

  through study completion, weekly for around 3 months

• Pain Self Efficacy

  through study completion, weekly for around 3 months

Other Outcomes (6)

• Quality of Life

  at week 0 and week 11

• Chronic Pain Self-Efficacy

  at week 0 and week 11

• Distress Tolerance

  at week 0 and week 11

Study Arms (3)

Baseline 10 Days

EXPERIMENTAL

10 days baseline before intervention starts.

Behavioral: MBLM

Baseline 17 Days

EXPERIMENTAL

17 days baseline before intervention starts.

Behavioral: MBLM

Baseline 24 Days

EXPERIMENTAL

24 days baseline before intervention starts.

Behavioral: MBLM

Interventions

MBLM BEHAVIORAL

Complex 8 week Mind-Body program.

Baseline 10 Days; Baseline 17 Days; Baseline 24 Days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Diakonie Kliniken Zschadraß: lead
• Chemnitz University of Technology: collaborator
• Technische Universität Dresden: collaborator

Study Sites (1)

Diakoniekliniken Zschadraß

Colditz, Saxony, 04680, Germany

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 7, 2019
• First Posted: September 13, 2019
• Study Start: September 2, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

DE (1)