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 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Other: Online pain education program||Not Applicable|
Participants' eligibility will be accessed based on the following details:
1. Inclusion criteria:
- . Age between 16 to 60;
- . Have a full-time job;
- . Resident of China;
- . Can read and understand Chinese;
- . History with non-cancer pain in past 6 months(Nicholas et al., 2013);
- . Pain score should be at least 2 when using Numeric Rating Scale, a 11-point numeric scale (Pieh et al., 2012);
- . Own a mobile phone and can access to mobile phone, computer and the internet.
2. Exclusion criteria
- . Hospitalized patients;
- . Experiencing a drug addiction problem;
- . 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.
- 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.
- 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.
- 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.
- 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?"
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
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.
- 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
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952910
|Contact: Mimi Tse, PhDfirstname.lastname@example.org|
|School of Nursing||Recruiting|
|Hung Hom, Kowloon, Hong Kong|
|Contact: Mimi Tse, PhD 852-27666541 email@example.com|
|Sub-Investigator: YA JIE LI, MSc in Nurs|
|Principal Investigator:||Mimi Tse, PhD||The Hong Kong Polytechnic University|