Impact of Psychology on Life Quality in Chronic and Cancer Pain Patients

Study Overview
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Brief Summary
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This study is to compare the effect of pain management program. We compare life quality, pain scores, sleep, anxiety and depression scores, and self report measures before and after mindfulness based pain management workshops.

Detailed Description
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Chronic pain is a growing problem in modern society. One in every five person in developed countries have this condition. Chronic pain is pain that persists longer than six months. It lead to psychological disorders such as anxiety, depression, anger and chronic fatigue. It decreases life quality, lower self-esteem and decrease work force. Because of these factors and the high cost of treatment, it impacts social economics highly. Chronic pain is caused by wind-up effect of the nervous system which the inhibitory signals are impaired. The nervous systems is therefore tuned up. Mindfulness based pain management helps lower this wind-up effect by noticing self, to observe and release stress. It has been proven to alter brain activity, enhance self control, improve attention and decrease secretion of stress hormones. It decreases pain and allow patients to regain control of life.

Official Title
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Impact of Psychology on Life Quality in Chronic and Cancer Pain Patients

Conditions
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Chronic Pain Syndrome, Psychology, Social

Intervention / Treatment
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* Behavioral: Pain management program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pain condition for over six months, with diagnosis by pain physician to be of chronic pain or cancer pain. Exclusion Criteria: Patients unable to communicate in Mandarin.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain management program<br>All enrolled patients participate in a 20 hour pain management program over a period of 8 weeks. The program is based on Mindfulness Based Stress Reduction with modifications to fulfill needs of the Taiwanese chronic pain population. | Behavioral: Pain management program<br>* Mindfulness based stress reduction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Brief Pain inventory | Assesses the severity of pain and its impact on functioning | Baseline | 
| Four week Brief Pain inventory | Assesses the severity of pain and its impact on functioning | Participants answer questionnaire at 4 weeks into pain management program | 
| Eight weeks Brief Pain inventory | Assesses the severity of pain and its impact on functioning | Participants answer questionnaire at 8 weeks into pain management program | 
| One year Brief Pain inventory | Assesses the severity of pain and its impact on functioning | Participants answer questionnaire at one year after completion of pain management program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Visual analog scale | Pain scale at numbers 0 to 10 | Baseline | 
| Four week Visual analog scale | Pain scale at numbers 0 to 10 | Participants answer questionnaire at 4 weeks into pain management program | 
| Eight week Visual analog scale | Pain scale at numbers 0 to 10 | Participants answer questionnaire at 8 weeks into pain management program | 
| One year Visual analog scale | Pain scale at numbers 0 to 10 | Participants answer questionnaire at one year after completion of pain management program | 
| Baseline Pain self-efficacy questionnaire | Assess the confidence people with ongoing pain have in performing activities while in pain. | Baseline | 
| Four week Pain self-efficacy questionnaire | Assess the confidence people with ongoing pain have in performing activities while in pain. | Participants answer questionnaire at 4 weeks into pain management program | 
| Eight week Pain self-efficacy questionnaire | Assess the confidence people with ongoing pain have in performing activities while in pain. | Participants answer questionnaire at 8 weeks into pain management program | 
| One year Pain self-efficacy questionnaire | Assess the confidence people with ongoing pain have in performing activities while in pain. | Participants answer questionnaire at one year after completion of pain management program | 
| Baseline Pain catastrophizing scale | self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations | Baseline | 
| Four week Pain catastrophizing scale | self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations | Participants answer questionnaire at 4 weeks into pain management program | 
| Eight week Pain catastrophizing scale | self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations | Participants answer questionnaire at eight weeks into pain management program | 
| One year Pain catastrophizing scale | self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations | Participants answer questionnaire at one year after completion of pain management program | 
| Baseline Depression, anxiety, and positive outlook scale | Assess mood in pain patients | Baseline | 
| Four week Depression, anxiety, and positive outlook scale | Assess mood in pain patients | Participants answer questionnaire at 4 weeks into pain management program | 
| Eight week Depression, anxiety, and positive outlook scale | Assess mood in pain patients | Participants answer questionnaire at 8 weeks into pain management program | 
| One year Depression, anxiety, and positive outlook scale | Assess mood in pain patients | Participants answer questionnaire at one year after completion of pain management program | 
| Baseline Chronic Pain Acceptance Questionnaire | Assessment of acceptance of pain. | Baseline | 
| Four week Chronic Pain Acceptance Questionnaire | Assessment of acceptance of pain. | Participants answer questionnaire at 4 weeks into pain management program | 
| Eight week Chronic Pain Acceptance Questionnaire | Assessment of acceptance of pain. | Participants answer questionnaire at 8 weeks into pain management program | 
| One year Chronic Pain Acceptance Questionnaire | Assessment of acceptance of pain. | Participants answer questionnaire at one year after completion of pain management program | 
| Baseline Five Facet Mindfulness Questionnaire | Assessment on the five aspects of mindfulness | Baseline | 
| Four week Five Facet Mindfulness Questionnaire | Assessment on the five aspects of mindfulness | Participants answer questionnaire at 4 weeks into pain management program | 
| Eight week Five Facet Mindfulness Questionnaire | Assessment on the five aspects of mindfulness | Participants answer questionnaire at 8 weeks into pain management program | 
| One year Five Facet Mindfulness Questionnaire | Assessment on the five aspects of mindfulness | Participants answer questionnaire at one year after completion of pain management program | 
| Baseline Pittsburgh Sleep Quality Index | Assesses sleep quality | Baseline | 
| Four week Pittsburgh Sleep Quality Index | Assesses sleep quality | Participants answer questionnaire at four weeks into pain management program | 
| Eight week Pittsburgh Sleep Quality Index | Assesses sleep quality | Participants answer questionnaire at 8 weeks into pain management program | 
| One year Pittsburgh Sleep Quality Index | Assesses sleep quality | Participants answer questionnaire at one year after completion of pain management program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, Mindfulness based stress reduction, psychology, pain management program