- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03718702
The Effectiveness of an Electronic Pain Management Programme (ePain) for Working Population With Chronic Pain
The Effectiveness of an Electronic Pain Management Programme (ePain) for Working Population With Chronic Pain: A Randomized Controlled Trial
Pain in commonly found in working population. The working population who aged from 15 to 64 is the largest portion of population in Hong Kong. Also, the prevalence of chronic pain in this population group is high. The issue requires special attention. Researches demonstrated pain affects a person in a multidimensional way. Pain induces negative effects to both the physical and psychological aspects. The levels of depression, anxiety, stress are increased and quality of life is decreased in people with chronic pain. They are interrelated to pain. As pain induced discomforts, people adopted self-initiated treatments as treatment. Pharmacological and non-pharmacological pain management interventions are commonly used. Although people used different ways to relieve the pain, they tend to bear the pain to work or take sick leave. This contributes to the work loss to the whole society.
Pain service in Hong Kong is scarce in the public and private sectors. It takes months for a pain sufferer to be arranged for a pain clinic follow-up. It is possible for the pain get worsen while waiting for the pain service. The pain can be difficult to treat afterwards. As self-initiated treatments are welcomed by the pain sufferers, pain education can be focused on empowering the pain sufferers on their pain knowledge and self-management techniques. The pain self-efficacy can be enhanced. The pain sufferers can be benefited from lowering the pain intensity and negative emotions. It can be a solution to develop an online pain management programme to ease the service demand.
Limited studies are found for online pain management programmes to improve the pain self-efficacy and self-management techniques. In order to fill the knowledge gap and service gap, the present study aims to evaluate an online pain management programme (ePain) in improving the self-efficacy, reduction of pain intensity, decreased levels of depression, anxiety and stress, and improving quality of life in pain management in adults with chronic pain. Participants are randomised to the intervention group or the control group.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kowloon
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Hung Hom, Kowloon, Hong Kong
- School of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults aged 15 to 65;
- Performed a formal job during the seven days before the intervention or worked for pay or profit during the seven days before the intervention;
- Able to read and understand traditional Chinese;
- With non-cancer chronic pain for at least three months;
- With pain scored one or above in the numeric rating scale from zero to ten in the Chinese version of Brief Pain Inventory (BPI-C)
Exclusion Criteria:
- Adults aged 15 below or above 65;
- Not performed any formal jobs for pay or profit during the seven days before the intervention;
- With cancer pain or non-cancer acute pain for less than 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
ePain will be accessible by the intervention group.
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Electronic pain management programme (ePain)
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No Intervention: Control group
No intervention will be applied to control group and they can download an educational pamphlet only.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain self-efficacy
Time Frame: Baseline, Week 3, Week 6 and Week 12
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Changes from baseline to Week 3, Week 6 and Week 12 in pain self-efficacy using the Pain Self-Efficacy Questionnaire
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Baseline, Week 3, Week 6 and Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain situations
Time Frame: Baseline, Week 3, Week 6 and Week 12
|
Changes from baseline to Week 3, Week 6 and Week 12 in pain situations using the Chinese version of Brief Pain Inventory (BPI-C)
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Baseline, Week 3, Week 6 and Week 12
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Negative emotions
Time Frame: Baseline, Week 6 and Week 12
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Changes from baseline to Week 6 and Week 12 in depression, anxiety and stress levels using the Depression Anxiety Stress Scale (DASS-21)
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Baseline, Week 6 and Week 12
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Changes in level of quality of life
Time Frame: Baseline, Week 6 and Week 12
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Changes from baseline to Week 6 and Week 12 in quality of life using the World Health Organization Quality of Life Instruments (WHOQOL-BREF)
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Baseline, Week 6 and Week 12
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Feedback
Time Frame: Week 6
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Open ended questions developed by the research team to collect comments of using ePain, including the user experience, webpage design, usefulness of ePain and items for improvement
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Week 6
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Collaborators and Investigators
Investigators
- Principal Investigator: Mimi Tse, PhD, The Hong Kong Polytechnic University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ePain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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