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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||148 participants|
|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|
Experimental: Intervention group
ePain will be accessible by the intervention group.
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.
- 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
- 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)
- 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)
- 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)
- 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
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
|Contact: Mimi Tse, PhDemail@example.com|
|School of Nursing||Recruiting|
|Hung Hom, Kowloon, Hong Kong|
|Contact: Mimi Tse, PhD 852-27666541 firstname.lastname@example.org|
|Sub-Investigator: Shuk Kwan Tang, MSc in Nurs|
|Sub-Investigator: Sau Fong Leung, PhD|
|Sub-Investigator: Theofanis Fotis, PhD|
|Principal Investigator:||Mimi Tse, PhD||The Hong Kong Polytechnic University|