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

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.

Study Overview

• Status: Unknown
• Conditions: Psychology, Social; Chronic Pain Syndrome
• Intervention / Treatment: Behavioral: Pain management program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Wei-Nung Teng, MD, PhD; Phone Number: 886938593179; Email: wnteng@vghtpe.gov.tw
    • Principal Investigator: Wei-Nung Teng, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain management program; 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; Mindfulness based stress reduction

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2020
• Primary Completion (Anticipated): March 30, 2021
• Study Completion (Anticipated): March 30, 2021

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: chronic pain; psychology; Mindfulness based stress reduction; pain management program
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Cancer Pain
• Other Study ID Numbers: 2019-08-008A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No