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The Effectiveness of an Electronic Pain Management Programme (ePain) for Working Population With Chronic Pain

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ClinicalTrials.gov Identifier: NCT03718702
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
TSE Mun Yee Mimi, The Hong Kong Polytechnic University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Other: ePain Not Applicable

Detailed Description:
Participants will register in ePain for an individual account. Then they will finish the the pre-test questionnaire. They will be randomized to either the intervention group or control group. ePain will be accessed by the participants in the intervention group. The control group will remain their regular activities. The participants in both groups will need to complete the pre-test (Week 1), process evaluation (Week 3), post-assessment (Week 6) and follow-up assessment (Week 12). Same questionnaire will be used in the assessments. Demographic data will be collected in Week 1. At Week 1, 3, 6 and 12, pain situation and pain self-efficacy will be collected. Data of negative emotions and quality of life will be collected at Week 1, 6 and 12. The control group will undergo the same assessment as the intervention group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Self-efficacy theory of behavioral change is adopted to guide the conceptual framework and development of the intervention. It was first introduced by Bandura in 1977. In the theory, self-efficacy would increase when a person participates actively in the activities to gain experience. There are two expectations in the model. The efficacy expectations of the person would contribute to the person's behaviour. The person performs the behaviour and would expect the outcomes and this is outcome expectations. The theory has been discussed for how to apply in health promotion. As the theory integrates self-efficacy and self-regulatory elements, people are benefited from the improved health outcomes which is resulted from the health behaviours.
Primary Purpose: Supportive Care
Official Title: The Effectiveness of an Electronic Pain Management Programme (ePain) for Working Population With Chronic Pain: A Randomized Controlled Trial
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
ePain will be accessible by the intervention group.
Other: ePain
Electronic pain management programme (ePain)

No Intervention: Control group
No intervention will be applied to control group and they can download an educational pamphlet only.



Primary Outcome Measures :
  1. Pain self-efficacy [ Time Frame: Baseline, Week 3, Week 6 and Week 12 ]
    Changes from baseline to Week 3, Week 6 and Week 12 in pain self-efficacy using the Pain Self-Efficacy Questionnaire


Secondary Outcome Measures :
  1. 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)

  2. Negative emotions [ Time Frame: Baseline, Week 6 and Week 12 ]
    Changes from baseline to Week 6 and Week 12 in depression, anxiety and stress levels using the Depression Anxiety Stress Scale (DASS-21)

  3. Changes in level of quality of life [ Time Frame: Baseline, Week 6 and Week 12 ]
    Changes from baseline to Week 6 and Week 12 in quality of life using the World Health Organization Quality of Life Instruments (WHOQOL-BREF)

  4. Feedback [ Time Frame: Week 6 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718702


Contacts
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Contact: Mimi Tse, PhD 852-27666541 mimi.tse@polyu.edu.hk

Locations
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Hong Kong
School of Nursing Recruiting
Hung Hom, Kowloon, Hong Kong
Contact: Mimi Tse, PhD    852-27666541    mimi.tse@polyu.edu.hk   
Sub-Investigator: Shuk Kwan Tang, MSc in Nurs         
Sub-Investigator: Sau Fong Leung, PhD         
Sub-Investigator: Theofanis Fotis, PhD         
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Mimi Tse, PhD The Hong Kong Polytechnic University

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Responsible Party: TSE Mun Yee Mimi, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03718702     History of Changes
Other Study ID Numbers: ePain
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by TSE Mun Yee Mimi, The Hong Kong Polytechnic University:
Chronic pain
Working population
Online learning

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms