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

Primary Purpose

Chronic Pain Syndrome, Psychology, Social

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Pain management program
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain Syndrome focused on measuring chronic pain, Mindfulness based stress reduction, psychology, pain management program

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pain management program

Arm Description

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.

Outcomes

Primary Outcome Measures

Baseline Brief Pain inventory
Assesses the severity of pain and its impact on functioning
Four week Brief Pain inventory
Assesses the severity of pain and its impact on functioning
Eight weeks Brief Pain inventory
Assesses the severity of pain and its impact on functioning
One year Brief Pain inventory
Assesses the severity of pain and its impact on functioning

Secondary Outcome Measures

Baseline Visual analog scale
Pain scale at numbers 0 to 10
Four week Visual analog scale
Pain scale at numbers 0 to 10
Eight week Visual analog scale
Pain scale at numbers 0 to 10
One year Visual analog scale
Pain scale at numbers 0 to 10
Baseline Pain self-efficacy questionnaire
Assess the confidence people with ongoing pain have in performing activities while in pain.
Four week Pain self-efficacy questionnaire
Assess the confidence people with ongoing pain have in performing activities while in pain.
Eight week Pain self-efficacy questionnaire
Assess the confidence people with ongoing pain have in performing activities while in pain.
One year Pain self-efficacy questionnaire
Assess the confidence people with ongoing pain have in performing activities while in pain.
Baseline Pain catastrophizing scale
self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations
Four week Pain catastrophizing scale
self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations
Eight week Pain catastrophizing scale
self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations
One year Pain catastrophizing scale
self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations
Baseline Depression, anxiety, and positive outlook scale
Assess mood in pain patients
Four week Depression, anxiety, and positive outlook scale
Assess mood in pain patients
Eight week Depression, anxiety, and positive outlook scale
Assess mood in pain patients
One year Depression, anxiety, and positive outlook scale
Assess mood in pain patients
Baseline Chronic Pain Acceptance Questionnaire
Assessment of acceptance of pain.
Four week Chronic Pain Acceptance Questionnaire
Assessment of acceptance of pain.
Eight week Chronic Pain Acceptance Questionnaire
Assessment of acceptance of pain.
One year Chronic Pain Acceptance Questionnaire
Assessment of acceptance of pain.
Baseline Five Facet Mindfulness Questionnaire
Assessment on the five aspects of mindfulness
Four week Five Facet Mindfulness Questionnaire
Assessment on the five aspects of mindfulness
Eight week Five Facet Mindfulness Questionnaire
Assessment on the five aspects of mindfulness
One year Five Facet Mindfulness Questionnaire
Assessment on the five aspects of mindfulness
Baseline Pittsburgh Sleep Quality Index
Assesses sleep quality
Four week Pittsburgh Sleep Quality Index
Assesses sleep quality
Eight week Pittsburgh Sleep Quality Index
Assesses sleep quality
One year Pittsburgh Sleep Quality Index
Assesses sleep quality

Full Information

First Posted
March 17, 2020
Last Updated
November 3, 2020
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04317391
Brief Title
Impact of Psychology on Life Quality in Chronic and Cancer Pain Patients
Official Title
Impact of Psychology on Life Quality in Chronic and Cancer Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 27, 2020 (Actual)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain Syndrome, Psychology, Social
Keywords
chronic pain, Mindfulness based stress reduction, psychology, pain management program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain management program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pain management program
Intervention Description
Mindfulness based stress reduction
Primary Outcome Measure Information:
Title
Baseline Brief Pain inventory
Description
Assesses the severity of pain and its impact on functioning
Time Frame
Baseline
Title
Four week Brief Pain inventory
Description
Assesses the severity of pain and its impact on functioning
Time Frame
Participants answer questionnaire at 4 weeks into pain management program
Title
Eight weeks Brief Pain inventory
Description
Assesses the severity of pain and its impact on functioning
Time Frame
Participants answer questionnaire at 8 weeks into pain management program
Title
One year Brief Pain inventory
Description
Assesses the severity of pain and its impact on functioning
Time Frame
Participants answer questionnaire at one year after completion of pain management program
Secondary Outcome Measure Information:
Title
Baseline Visual analog scale
Description
Pain scale at numbers 0 to 10
Time Frame
Baseline
Title
Four week Visual analog scale
Description
Pain scale at numbers 0 to 10
Time Frame
Participants answer questionnaire at 4 weeks into pain management program
Title
Eight week Visual analog scale
Description
Pain scale at numbers 0 to 10
Time Frame
Participants answer questionnaire at 8 weeks into pain management program
Title
One year Visual analog scale
Description
Pain scale at numbers 0 to 10
Time Frame
Participants answer questionnaire at one year after completion of pain management program
Title
Baseline Pain self-efficacy questionnaire
Description
Assess the confidence people with ongoing pain have in performing activities while in pain.
Time Frame
Baseline
Title
Four week Pain self-efficacy questionnaire
Description
Assess the confidence people with ongoing pain have in performing activities while in pain.
Time Frame
Participants answer questionnaire at 4 weeks into pain management program
Title
Eight week Pain self-efficacy questionnaire
Description
Assess the confidence people with ongoing pain have in performing activities while in pain.
Time Frame
Participants answer questionnaire at 8 weeks into pain management program
Title
One year Pain self-efficacy questionnaire
Description
Assess the confidence people with ongoing pain have in performing activities while in pain.
Time Frame
Participants answer questionnaire at one year after completion of pain management program
Title
Baseline Pain catastrophizing scale
Description
self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations
Time Frame
Baseline
Title
Four week Pain catastrophizing scale
Description
self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations
Time Frame
Participants answer questionnaire at 4 weeks into pain management program
Title
Eight week Pain catastrophizing scale
Description
self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations
Time Frame
Participants answer questionnaire at eight weeks into pain management program
Title
One year Pain catastrophizing scale
Description
self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations
Time Frame
Participants answer questionnaire at one year after completion of pain management program
Title
Baseline Depression, anxiety, and positive outlook scale
Description
Assess mood in pain patients
Time Frame
Baseline
Title
Four week Depression, anxiety, and positive outlook scale
Description
Assess mood in pain patients
Time Frame
Participants answer questionnaire at 4 weeks into pain management program
Title
Eight week Depression, anxiety, and positive outlook scale
Description
Assess mood in pain patients
Time Frame
Participants answer questionnaire at 8 weeks into pain management program
Title
One year Depression, anxiety, and positive outlook scale
Description
Assess mood in pain patients
Time Frame
Participants answer questionnaire at one year after completion of pain management program
Title
Baseline Chronic Pain Acceptance Questionnaire
Description
Assessment of acceptance of pain.
Time Frame
Baseline
Title
Four week Chronic Pain Acceptance Questionnaire
Description
Assessment of acceptance of pain.
Time Frame
Participants answer questionnaire at 4 weeks into pain management program
Title
Eight week Chronic Pain Acceptance Questionnaire
Description
Assessment of acceptance of pain.
Time Frame
Participants answer questionnaire at 8 weeks into pain management program
Title
One year Chronic Pain Acceptance Questionnaire
Description
Assessment of acceptance of pain.
Time Frame
Participants answer questionnaire at one year after completion of pain management program
Title
Baseline Five Facet Mindfulness Questionnaire
Description
Assessment on the five aspects of mindfulness
Time Frame
Baseline
Title
Four week Five Facet Mindfulness Questionnaire
Description
Assessment on the five aspects of mindfulness
Time Frame
Participants answer questionnaire at 4 weeks into pain management program
Title
Eight week Five Facet Mindfulness Questionnaire
Description
Assessment on the five aspects of mindfulness
Time Frame
Participants answer questionnaire at 8 weeks into pain management program
Title
One year Five Facet Mindfulness Questionnaire
Description
Assessment on the five aspects of mindfulness
Time Frame
Participants answer questionnaire at one year after completion of pain management program
Title
Baseline Pittsburgh Sleep Quality Index
Description
Assesses sleep quality
Time Frame
Baseline
Title
Four week Pittsburgh Sleep Quality Index
Description
Assesses sleep quality
Time Frame
Participants answer questionnaire at four weeks into pain management program
Title
Eight week Pittsburgh Sleep Quality Index
Description
Assesses sleep quality
Time Frame
Participants answer questionnaire at 8 weeks into pain management program
Title
One year Pittsburgh Sleep Quality Index
Description
Assesses sleep quality
Time Frame
Participants answer questionnaire at one year after completion of pain management program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Nung Teng, MD, PhD
Phone
886938593179
Email
wnteng@vghtpe.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Sung Sung, MD, PhD
Phone
886938593136
Email
cssung@vghtpe.gov.tw
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Nung Teng, MD, PhD
Phone
886938593179
Email
wnteng@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Wei-Nung Teng, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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