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An Online Pain Education Program for Working Adults

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ClinicalTrials.gov Identifier: NCT03952910
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
TSE Mun Yee Mimi, The Hong Kong Polytechnic University

Brief Summary:
Pain is popular among working population and it is a strong predictor of poor quality of life. In this study, an internet-delivered pain education program will be provided to working adults aims at helping patients equip with pain-related knowledge and useful skills and evaluate the effectiveness of the internet-delivered program. Participants will be recruited follow snowball sampling and will be randomly allocated to experimental group and control group by 1:1 ratio. The internet-delivered pain education will last for 4 weeks with one-month follow-up. Basic knowledge of pain, pharmacological and non-pharmacological treatment and related resources will be introduced in the program. Pain intensity, pain-related disability, anxiety, depression and self-efficacy will be measured in baseline post-treatment and at one-month follow-up. Acceptability and satisfaction to the program will also collected.

Condition or disease Intervention/treatment Phase
Chronic Pain Other: Online pain education program Not Applicable

Detailed Description:

Participants' eligibility will be accessed based on the following details:

1. Inclusion criteria:

  1. . Age between 16 to 60;
  2. . Have a full-time job;
  3. . Resident of China;
  4. . Can read and understand Chinese;
  5. . History with non-cancer pain in past 6 months(Nicholas et al., 2013);
  6. . Pain score should be at least 2 when using Numeric Rating Scale, a 11-point numeric scale (Pieh et al., 2012);
  7. . Own a mobile phone and can access to mobile phone, computer and the internet.

2. Exclusion criteria

  1. . Hospitalized patients;
  2. . Experiencing a drug addiction problem;
  3. . Further medical and surgical treatments or interventions is planned.

The outcome measures will be considered in four aspects, physical, psychological, psycho-social using a battery of questionnaires which were used in the previous similar studies and evaluation to the program will be measured by asking several questions. As the study will be conducted in China, all the questionnaires will use Chinese version.

  1. Physical Brief Pain Inventory (BPI): The BPI is a brief, self-administered questionnaire us. Pain severity is assessed by four items and pain interference by seven items. The items are rated on a scale ranging from 0 to 10. Previous study showed that BPI can used to measure not only cancer pain but also chronic pain and proved that BPI has good internal consistency and acceptable test-retest reliability.
  2. Psychological Depression Anxiety Stress Scales (DASS): The DASS is a self-report instrument to measure three negative emotional states including depression, anxiety and stress. The previous study demonstrated that DASS has excellent internal consistency and validity was also proved.
  3. Psycho-social The Pain Self-efficacy Questionnaire (PSEQ): A 10 item questionnaire assess the patient's beliefs about his or her ability to accomplish daily activities with pain. Higher score indicate greater pain-related self-efficacy.
  4. Satisfaction and acceptability Several questions will be asked at the end of the program to assess participants' satisfaction and acceptability of the program: (1) "Do you think this online pain management program useful?" "Does it worth your time following the program?" "Would you feel confident to recommend this program?" The questions were used in the previous studies to assess the acceptability of the internet-delivered program. Open-ended questions will also be used including "How do you think about this program?" "What are the strengths of the program?" "What are the disadvantages of the program?"

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: An Online Pain Education Program for Working Adults: a Pilot Randomized Controlled Trial With One-month Follow-up
Actual Study Start Date : July 5, 2019
Estimated Primary Completion Date : July 5, 2020
Estimated Study Completion Date : July 5, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Experimental group
Online pain education program will be accessible by the intervention group
Other: Online pain education program
Online pain education program

No Intervention: Control group
No intervention for the control group, only one-page simple material related to pain will be provided.



Primary Outcome Measures :
  1. Pain intensity and pain interference [ Time Frame: Baseline, Week 4, one-month after intervention ]
    Changes from baseline to Week 4 and one-month after the intervention in pain intensity and pain interference using Brief Pain Inventory


Secondary Outcome Measures :
  1. Depression, Anxiety and Stress [ Time Frame: Baseline, Week 4, one-month after intervention ]
    Changes from baseline to Week 4 and one-month after the intervention in depression, anxiety and stress using Depression Anxiety Stress Scale - 21 Scale (DASS-21). The DASS-21 is a set of three self-reported scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items and divided into subscales. The score of each item ranges feom 0 to 3 (o = do not apply to me at all, 3 = applied to me very much or most of the time). Total score is multiplied by 2 of the sum of each subscales. Higher score indicates the greater degree of the symptom.

  2. Pain self-efficacy [ Time Frame: Baseline, Week 4, one-month after intervention ]
    Changes from baseline to Week 4 and one-month after the intervention in pain self-efficacy using Pain Self-Efficacy Questionnaire (PSEQ). PSEQ is a 10-item questionnaire assessing the confidence people with ongoing pain have in performing activities while in pain. Score of each item ranges from 0 to 6 (0 = not at all confident, 6 = completely confident). A total score is calculated by adding the scores for each item which ranging from 0 to 60. Higher scores reflect stronger self-efficacy beliefs.

  3. Participant's Satisfaction and acceptability to the program [ Time Frame: Week 4 ]
    Participants satisfaction and acceptability to the online pain education program will be assessed at post-treatment by several questions, including "do you think this online pain education program useful?" "does it worth your time following the program?" "would you feel confident to recommend this program to others?" Participants are required to answer the questions by "Yes" or "No". Open-ended question "what are the advantages and disadvantages of the program?" will also be asked. These questions have in the previous studies to assess the acceptability and satisfaction to the internet-delivered program.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age between 16 to 60;
  2. Have a full-time job;
  3. Resident of China;
  4. Can read and understand Chinese;
  5. History with non-cancer pain in past 6 months;
  6. Pain score should be at least 2 when using Numeric Rating Scale, a 11-point numeric scale;
  7. Own a mobile phone and can access to mobile phone, computer and the internet.

Exclusion Criteria:

  1. Hospitalized patients;
  2. Experiencing a drug addiction problem;
  3. Further medical and surgical treatments or interventions is planned.

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): NCT03952910


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: YA JIE LI, MSc in Nurs         
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, Associate professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03952910     History of Changes
Other Study ID Numbers: OPEP
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 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 adults
Pain education
Internet-delivered
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms