Ignite Creation Date:
2024-05-05 @ 11:45 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01407549
Status:
COMPLETED
Last Update Posted:
2015-06-30
First Post:
2011-07-26
Brief Title:
The Influence of Mindfulness Based Intervention on Pain Perception in Chronic Pain Patients
Sponsor:
Meir Medical Center
Organization:
Meir Medical Center
Study Overview
Official Title:
The Influence of Mindfulness Based Intervention on Pain Perception in Chronic Pain Patients Evaluating Personal Characteristics and Possible Mechanism
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Chronic pain is a common condition in the general population causing great suffering in both physical and mental aspects Previous research shows that mindfulness based interventions help chronic pain patients to cope better with their pain and improve their quality of life Although evidence support the efficacy of mindfulness based interventions for chronic pain it is still unclear whether this efficacy involves a direct influence on sensory aspects of pain perception Further more the mechanisms of change responsible for the improved life quality and the possible moderating factors that may influence treatment efficacy are still unknown
Aim The purpose of this study is to evaluate the efficacy of mindfulness based intervention on pain perception and quality of life in individuals suffering from chronic pain The investigators will also evaluate potential mechanisms responsible for the change following mindfulness practice Finally the investigators will examine the role of personal characteristics as potential moderating factors of mindfulness effect
Hypothesis The investigators hypothesize that 1 compared to a waitlist control group chronic pain patients participating in a full mindfulness based program will report greater improvements in a pain severity b quality of life and psychological symptoms and c will demonstrate changes in physiological characteristics of pain 2 Changes following the mindfulness based program will be mediated by change in pain catastrophizing self regulation capacity and pain acceptance 3 The investigators hypothesize that gender baseline mindfulness and anxiety sensitivity will moderate the efficacy of the mindfulness based program
Method A randomized controlled design will be used to evaluate the efficacy of mindfulness based intervention on pain perception and quality of life in individuals suffering from chronic recurrent low back pain and osteoarthritis Participants will be randomized to a mindfulness based treatment group or to a waitlist control group and will be assessed for psychological variables and psychophysical pain assessment before treatment Participants allocated to treatment group will then attend six group meetings in which they will learn and practice different mindfulness meditation techniques and will be asked to practice these techniques on a daily basis Post treatment assessments will take place at the end of the intervention for both treatment and control groups
Aim The purpose of this study is to evaluate the efficacy of mindfulness based intervention on pain perception and quality of life in individuals suffering from chronic pain The investigators will also evaluate potential mechanisms responsible for the change following mindfulness practice Finally the investigators will examine the role of personal characteristics as potential moderating factors of mindfulness effect
Hypothesis The investigators hypothesize that 1 compared to a waitlist control group chronic pain patients participating in a full mindfulness based program will report greater improvements in a pain severity b quality of life and psychological symptoms and c will demonstrate changes in physiological characteristics of pain 2 Changes following the mindfulness based program will be mediated by change in pain catastrophizing self regulation capacity and pain acceptance 3 The investigators hypothesize that gender baseline mindfulness and anxiety sensitivity will moderate the efficacy of the mindfulness based program
Method A randomized controlled design will be used to evaluate the efficacy of mindfulness based intervention on pain perception and quality of life in individuals suffering from chronic recurrent low back pain and osteoarthritis Participants will be randomized to a mindfulness based treatment group or to a waitlist control group and will be assessed for psychological variables and psychophysical pain assessment before treatment Participants allocated to treatment group will then attend six group meetings in which they will learn and practice different mindfulness meditation techniques and will be asked to practice these techniques on a daily basis Post treatment assessments will take place at the end of the intervention for both treatment and control groups
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None