NCT04317391

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

March 27, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

March 17, 2020

Last Update Submit

November 3, 2020

Conditions

Chronic Pain SyndromePsychology, Social

Keywords

chronic painMindfulness based stress reductionpsychologypain management program

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (28)

  • Baseline Visual analog scale

    Baseline

  • Four week Visual analog scale

    Participants answer questionnaire at 4 weeks into pain management program

  • Eight week Visual analog scale

    Participants answer questionnaire at 8 weeks into pain management program

  • One year Visual analog scale

    Participants answer questionnaire at one year after completion of pain management program

  • Baseline Pain self-efficacy questionnaire

    Baseline

  • +23 more secondary outcomes

Study Arms (1)

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.

Behavioral: Pain management program

Interventions

Pain management programBEHAVIORAL

Mindfulness based stress reduction

Pain management program

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pain condition for over six months, with diagnosis by pain physician to be of chronic pain or cancer pain.

You may not qualify if:

  • Patients unable to communicate in Mandarin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Wei-Nung Teng, MD, PhD

CONTACT

886938593179wnteng@vghtpe.gov.tw

Chun-Sung Sung, MD, PhD

CONTACT

886938593136cssung@vghtpe.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 23, 2020

Study Start

March 27, 2020

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

TW(1)