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

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
ePain
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring Chronic pain, Working population, Online learning

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

ePain will be accessible by the intervention group.

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

Outcomes

Primary Outcome Measures

Pain self-efficacy
Changes from baseline to Week 3, Week 6 and Week 12 in pain self-efficacy using the Pain Self-Efficacy Questionnaire

Secondary Outcome Measures

Pain situations
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
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
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
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

Full Information

First Posted
October 23, 2018
Last Updated
April 8, 2020
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT03718702
Brief Title
The Effectiveness of an Electronic Pain Management Programme (ePain) for Working Population With Chronic Pain
Official Title
The Effectiveness of an Electronic Pain Management Programme (ePain) for Working Population With Chronic Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pain, Working population, Online learning

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
ePain will be accessible by the intervention group.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention will be applied to control group and they can download an educational pamphlet only.
Intervention Type
Other
Intervention Name(s)
ePain
Intervention Description
Electronic pain management programme (ePain)
Primary Outcome Measure Information:
Title
Pain self-efficacy
Description
Changes from baseline to Week 3, Week 6 and Week 12 in pain self-efficacy using the Pain Self-Efficacy Questionnaire
Time Frame
Baseline, Week 3, Week 6 and Week 12
Secondary Outcome Measure Information:
Title
Pain situations
Description
Changes from baseline to Week 3, Week 6 and Week 12 in pain situations using the Chinese version of Brief Pain Inventory (BPI-C)
Time Frame
Baseline, Week 3, Week 6 and Week 12
Title
Negative emotions
Description
Changes from baseline to Week 6 and Week 12 in depression, anxiety and stress levels using the Depression Anxiety Stress Scale (DASS-21)
Time Frame
Baseline, Week 6 and Week 12
Title
Changes in level of quality of life
Description
Changes from baseline to Week 6 and Week 12 in quality of life using the World Health Organization Quality of Life Instruments (WHOQOL-BREF)
Time Frame
Baseline, Week 6 and Week 12
Title
Feedback
Description
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
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mimi Tse, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing
City
Hung Hom
State/Province
Kowloon
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32448387
Citation
Tang SK, Tse MMY, Leung SF, Fotis T. The effectiveness of an electronic pain management programme for the working population with chronic pain: study protocol for a randomized controlled trial. Trials. 2020 May 24;21(1):421. doi: 10.1186/s13063-020-04348-5.
Results Reference
derived

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

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