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

November 3, 2020 updated by: Taipei Veterans General Hospital, Taiwan
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Wei-Nung Teng, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Baseline Brief Pain inventory
Time Frame: Baseline
Assesses the severity of pain and its impact on functioning
Baseline
Four week Brief Pain inventory
Time Frame: Participants answer questionnaire at 4 weeks into pain management program
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
Time Frame: Participants answer questionnaire at 8 weeks into pain management program
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
Time Frame: Participants answer questionnaire at one year after completion of pain management program
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Baseline Visual analog scale
Time Frame: Baseline
Pain scale at numbers 0 to 10
Baseline
Four week Visual analog scale
Time Frame: Participants answer questionnaire at 4 weeks into pain management program
Pain scale at numbers 0 to 10
Participants answer questionnaire at 4 weeks into pain management program
Eight week Visual analog scale
Time Frame: Participants answer questionnaire at 8 weeks into pain management program
Pain scale at numbers 0 to 10
Participants answer questionnaire at 8 weeks into pain management program
One year Visual analog scale
Time Frame: Participants answer questionnaire at one year after completion of pain management program
Pain scale at numbers 0 to 10
Participants answer questionnaire at one year after completion of pain management program
Baseline Pain self-efficacy questionnaire
Time Frame: Baseline
Assess the confidence people with ongoing pain have in performing activities while in pain.
Baseline
Four week Pain self-efficacy questionnaire
Time Frame: Participants answer questionnaire at 4 weeks into pain management program
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
Time Frame: Participants answer questionnaire at 8 weeks into pain management program
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
Time Frame: Participants answer questionnaire at one year after completion of pain management program
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
Time Frame: Baseline
self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations
Baseline
Four week Pain catastrophizing scale
Time Frame: Participants answer questionnaire at 4 weeks into pain management program
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
Time Frame: Participants answer questionnaire at eight weeks into pain management program
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
Time Frame: Participants answer questionnaire at one year after completion of pain management program
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
Time Frame: Baseline
Assess mood in pain patients
Baseline
Four week Depression, anxiety, and positive outlook scale
Time Frame: Participants answer questionnaire at 4 weeks into pain management program
Assess mood in pain patients
Participants answer questionnaire at 4 weeks into pain management program
Eight week Depression, anxiety, and positive outlook scale
Time Frame: Participants answer questionnaire at 8 weeks into pain management program
Assess mood in pain patients
Participants answer questionnaire at 8 weeks into pain management program
One year Depression, anxiety, and positive outlook scale
Time Frame: Participants answer questionnaire at one year after completion of pain management program
Assess mood in pain patients
Participants answer questionnaire at one year after completion of pain management program
Baseline Chronic Pain Acceptance Questionnaire
Time Frame: Baseline
Assessment of acceptance of pain.
Baseline
Four week Chronic Pain Acceptance Questionnaire
Time Frame: Participants answer questionnaire at 4 weeks into pain management program
Assessment of acceptance of pain.
Participants answer questionnaire at 4 weeks into pain management program
Eight week Chronic Pain Acceptance Questionnaire
Time Frame: Participants answer questionnaire at 8 weeks into pain management program
Assessment of acceptance of pain.
Participants answer questionnaire at 8 weeks into pain management program
One year Chronic Pain Acceptance Questionnaire
Time Frame: Participants answer questionnaire at one year after completion of pain management program
Assessment of acceptance of pain.
Participants answer questionnaire at one year after completion of pain management program
Baseline Five Facet Mindfulness Questionnaire
Time Frame: Baseline
Assessment on the five aspects of mindfulness
Baseline
Four week Five Facet Mindfulness Questionnaire
Time Frame: Participants answer questionnaire at 4 weeks into pain management program
Assessment on the five aspects of mindfulness
Participants answer questionnaire at 4 weeks into pain management program
Eight week Five Facet Mindfulness Questionnaire
Time Frame: Participants answer questionnaire at 8 weeks into pain management program
Assessment on the five aspects of mindfulness
Participants answer questionnaire at 8 weeks into pain management program
One year Five Facet Mindfulness Questionnaire
Time Frame: Participants answer questionnaire at one year after completion of pain management program
Assessment on the five aspects of mindfulness
Participants answer questionnaire at one year after completion of pain management program
Baseline Pittsburgh Sleep Quality Index
Time Frame: Baseline
Assesses sleep quality
Baseline
Four week Pittsburgh Sleep Quality Index
Time Frame: Participants answer questionnaire at four weeks into pain management program
Assesses sleep quality
Participants answer questionnaire at four weeks into pain management program
Eight week Pittsburgh Sleep Quality Index
Time Frame: Participants answer questionnaire at 8 weeks into pain management program
Assesses sleep quality
Participants answer questionnaire at 8 weeks into pain management program
One year Pittsburgh Sleep Quality Index
Time Frame: Participants answer questionnaire at one year after completion of pain management program
Assesses sleep quality
Participants answer questionnaire at one year after completion of pain management program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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