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

Chronic Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04317391
• Other study ID #: 2019-08-008A
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: November 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Wei-Nung Teng, MD, PhD
• Phone: 886938593179
• Email: wnteng[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Pain
• Chronic Pain
• Chronic Pain Syndrome
• Psychology, Social

Intervention

Behavioral:
• Pain management program
Mindfulness based stress reduction

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

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