Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04743492
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2021-02-03
Brief Title:
Pain Resilience and Holistic Health Care of Migraine
Sponsor:
Changhua Christian Hospital
Organization:
Changhua Christian Hospital
Study Overview
Official Title:
How Pain Resilience Determines the Efficacy of Holistic Health Care of Patients With Migraine
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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:
The purpose of this study is to investigate how pain resilience as a personality characteristic or a strength moderate the efficacy of treatment for patients with migraine
The primary objective of the current study is to explore the moderation effect of pain resilience between initial pain and the treatment outcome of the holistic healthcare programs The investigators hypothesize that participants with higher level of pain resilience will show more improvements in the quality of life less disability assessed with the Migraine Disability Assessment Test MIDAS less frequency and lower severity of pain and higher heart-rate variability after training A secondary finding that can be obtained through the study is the comparison between the enhancement of heart rate variability in participants receiving different kinds of non-pharmacological therapies
The primary objective of the current study is to explore the moderation effect of pain resilience between initial pain and the treatment outcome of the holistic healthcare programs The investigators hypothesize that participants with higher level of pain resilience will show more improvements in the quality of life less disability assessed with the Migraine Disability Assessment Test MIDAS less frequency and lower severity of pain and higher heart-rate variability after training A secondary finding that can be obtained through the study is the comparison between the enhancement of heart rate variability in participants receiving different kinds of non-pharmacological therapies
Detailed Description:
IntroductionA multi-national research that included data from Taiwan found that chronic headache is one of the top two disorders alongside with chronic low back pain with the most patients having longest years of living with disabilities through year 1999 to 2017 It does not only impact a sufferers ability to work but also limit ones participation in a variety of daily housework leisure activities etc Quality of life is also impacted According to a systematic review on behavioral interventions for migraine cognitive behavioral therapy CBT is one of the most common non-pharmacological practices implemented and studied CBT has been found to be effective in reducing the intensity and frequency of headache compared to waitlist controls Another commonly discussed non-pharmacological treatment for migraine is exercise therapy
In regard to the controversial findings from therapeutic clinical trials the unsolved puzzle is why do some show improvements while the others remained unchanged or worse It is found that psychological resilience for pain can be a determining factor in task persistence despite the interruption of pain Pain resilience specifically refers to the cognitive and behavioral aspects of an individual when one is trying to deal with pain In a study investigating negative pain beliefs ie fear avoidance and pain catastrophizing and pain outcomes functional and movement aspects pain resilience was found to moderate the relationship between pain beliefs and pain outcomes The authors found that only in individuals with low level of pain resilience was the negative pain beliefs related to greater movement-relate pain Since pain resilience is such an important capacity dynamic process in coping with chronic pain the current study aims at investigating how pain resilience can be a moderating factor determining the outcome of pain management in patients with migraine
ObjectivesThe primary objective of the current study is to explore the moderation effect of pain resilience between initial pain and the treatment outcome of the holistic healthcare programs The investigators hypothesize that participants with higher level of pain resilience will show more improvements in the quality of life less disability assessed with MIDAS less frequency and lower severity of pain and higher heart-rate variability after training A secondary finding that can be obtained through the study is the comparison between the enhancement of heart rate variability in participants receiving different kinds of non-pharmacological therapies
In regard to the controversial findings from therapeutic clinical trials the unsolved puzzle is why do some show improvements while the others remained unchanged or worse It is found that psychological resilience for pain can be a determining factor in task persistence despite the interruption of pain Pain resilience specifically refers to the cognitive and behavioral aspects of an individual when one is trying to deal with pain In a study investigating negative pain beliefs ie fear avoidance and pain catastrophizing and pain outcomes functional and movement aspects pain resilience was found to moderate the relationship between pain beliefs and pain outcomes The authors found that only in individuals with low level of pain resilience was the negative pain beliefs related to greater movement-relate pain Since pain resilience is such an important capacity dynamic process in coping with chronic pain the current study aims at investigating how pain resilience can be a moderating factor determining the outcome of pain management in patients with migraine
ObjectivesThe primary objective of the current study is to explore the moderation effect of pain resilience between initial pain and the treatment outcome of the holistic healthcare programs The investigators hypothesize that participants with higher level of pain resilience will show more improvements in the quality of life less disability assessed with MIDAS less frequency and lower severity of pain and higher heart-rate variability after training A secondary finding that can be obtained through the study is the comparison between the enhancement of heart rate variability in participants receiving different kinds of non-pharmacological therapies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None