Chronic Pain SyndromeNCT04317391
Impact of Psychology on Life Quality in Chronic and Cancer Pain Patients
A study testing Pain management program in people with Chronic Pain Syndrome and Psychology, Social, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Pain Syndrome, Psychology, Social
- What is being tested?
- Pain management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Mar 2020to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain condition for over six months, with diagnosis by pain physician to be of chronic pain or cancer pain.
Who cannot join
- Patients unable to communicate in Mandarin.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Wei-Nung Teng, MD, PhD, 886938593179, wnteng@vghtpe.gov.tw
Wei-Nung Teng, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Chronic Pain Syndrome, Psychology, Social
- Being tested
- Pain management program
- Keywords
- chronic pain, Mindfulness based stress reduction, psychology, pain management program
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain management programBehavioural
Mindfulness based stress reduction
| Study group | Role | What they receive |
|---|---|---|
| Pain management program | Experimental | 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. Receives: Behavioral: Pain management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Brief Pain inventory
Assesses the severity of pain and its impact on functioning
Measured: Baseline
Four week Brief Pain inventory
Assesses the severity of pain and its impact on functioning
Measured: 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
Measured: 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
Measured: Participants answer questionnaire at one year after completion of pain management program
Secondary outcomes (28)
Baseline Visual analog scale
Pain scale at numbers 0 to 10
Measured: Baseline
Four week Visual analog scale
Pain scale at numbers 0 to 10
Measured: Participants answer questionnaire at 4 weeks into pain management program
Eight week Visual analog scale
Pain scale at numbers 0 to 10
Measured: Participants answer questionnaire at 8 weeks into pain management program
One year Visual analog scale
Pain scale at numbers 0 to 10
Measured: 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.
Measured: Baseline
Four week Pain self-efficacy questionnaire
Assess the confidence people with ongoing pain have in performing activities while in pain.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline
Four week Pain catastrophizing scale
self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations
Measured: 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
Measured: 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
Measured: Participants answer questionnaire at one year after completion of pain management program
Baseline Depression, anxiety, and positive outlook scale
Assess mood in pain patients
Measured: Baseline
Four week Depression, anxiety, and positive outlook scale
Assess mood in pain patients
Measured: Participants answer questionnaire at 4 weeks into pain management program
Eight week Depression, anxiety, and positive outlook scale
Assess mood in pain patients
Measured: Participants answer questionnaire at 8 weeks into pain management program
One year Depression, anxiety, and positive outlook scale
Assess mood in pain patients
Measured: Participants answer questionnaire at one year after completion of pain management program
Baseline Chronic Pain Acceptance Questionnaire
Assessment of acceptance of pain.
Measured: Baseline
Four week Chronic Pain Acceptance Questionnaire
Assessment of acceptance of pain.
Measured: Participants answer questionnaire at 4 weeks into pain management program
Eight week Chronic Pain Acceptance Questionnaire
Assessment of acceptance of pain.
Measured: Participants answer questionnaire at 8 weeks into pain management program
One year Chronic Pain Acceptance Questionnaire
Assessment of acceptance of pain.
Measured: Participants answer questionnaire at one year after completion of pain management program
Baseline Five Facet Mindfulness Questionnaire
Assessment on the five aspects of mindfulness
Measured: Baseline
Four week Five Facet Mindfulness Questionnaire
Assessment on the five aspects of mindfulness
Measured: Participants answer questionnaire at 4 weeks into pain management program
Eight week Five Facet Mindfulness Questionnaire
Assessment on the five aspects of mindfulness
Measured: Participants answer questionnaire at 8 weeks into pain management program
One year Five Facet Mindfulness Questionnaire
Assessment on the five aspects of mindfulness
Measured: Participants answer questionnaire at one year after completion of pain management program
Baseline Pittsburgh Sleep Quality Index
Assesses sleep quality
Measured: Baseline
Four week Pittsburgh Sleep Quality Index
Assesses sleep quality
Measured: Participants answer questionnaire at four weeks into pain management program
Eight week Pittsburgh Sleep Quality Index
Assesses sleep quality
Measured: Participants answer questionnaire at 8 weeks into pain management program
One year Pittsburgh Sleep Quality Index
Assesses sleep quality
Measured: Participants answer questionnaire at one year after completion of pain management program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start27 Mar 2020
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317391
- Sponsor's protocol ID
- 2019-08-008A
- Status last verified
- Nov 2020
- First submitted
- 17 Mar 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Psychology on Life Quality in Chronic and Cancer Pain Patients
- ClinicalTrials.gov ID
- NCT04317391
- Acronym / sponsor ID
- 2019-08-008A
- Conditions
- Chronic Pain Syndrome, Psychology, Social
- Keywords
- chronic pain, Mindfulness based stress reduction, psychology, pain management program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain management program | Experimental | Behavioral: Pain management programAll 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pain condition for over six months, with diagnosis by pain physician to be of chronic pain or cancer pain.
Key exclusion criteria (1 listed)
- Patients unable to communicate in Mandarin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain management programMindfulness based stress reduction | Behavioural | Pain management program |
Primary outcome
Baseline Brief Pain inventory
Time frame: Baseline
Assesses the severity of pain and its impact on functioning
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
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
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
28 secondary outcomes
Baseline Visual analog scale
Time frame: Baseline
Four week Visual analog scale
Time frame: 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
One year Visual analog scale
Time frame: Participants answer questionnaire at one year after completion of pain management program
Baseline Pain self-efficacy questionnaire
Time frame: Baseline
Four week Pain self-efficacy questionnaire
Time frame: 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
One year Pain self-efficacy questionnaire
Time frame: Participants answer questionnaire at one year after completion of pain management program
Baseline Pain catastrophizing scale
Time frame: Baseline
Four week Pain catastrophizing scale
Time frame: 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
One year Pain catastrophizing scale
Time frame: Participants answer questionnaire at one year after completion of pain management program
Baseline Depression, anxiety, and positive outlook scale
Time frame: Baseline
Four week Depression, anxiety, and positive outlook scale
Time frame: 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
One year Depression, anxiety, and positive outlook scale
Time frame: Participants answer questionnaire at one year after completion of pain management program
Baseline Chronic Pain Acceptance Questionnaire
Time frame: Baseline
Four week Chronic Pain Acceptance Questionnaire
Time frame: 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
One year Chronic Pain Acceptance Questionnaire
Time frame: Participants answer questionnaire at one year after completion of pain management program
Baseline Five Facet Mindfulness Questionnaire
Time frame: Baseline
Four week Five Facet Mindfulness Questionnaire
Time frame: 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
One year Five Facet Mindfulness Questionnaire
Time frame: Participants answer questionnaire at one year after completion of pain management program
Baseline Pittsburgh Sleep Quality Index
Time frame: Baseline
Four week Pittsburgh Sleep Quality Index
Time frame: 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
One year Pittsburgh Sleep Quality Index
Time frame: Participants answer questionnaire at one year after completion of pain management program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain management program in people with Chronic Pain Syndrome and Psychology, Social, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Nung Teng, MD, PhD (886938593179, wnteng@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Brief Pain inventory (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.