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Chronic PainNCT03952910

An Online Pain Education Program for Working Adults

A study testing Online pain education program in people with Chronic Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Pain
What is being tested?
Online pain education program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteHong Kong
Study dates
5 Jul 2019to 5 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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;
  • Pain score should be at least 2 when using Numeric Rating Scale, a 11-point numeric scale;
  • Own a mobile phone and can access to mobile phone, computer and the internet.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site, 1 recruiting
  • School of Nursing

    Hung Hom, Kowloon

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

    YA JIE LI, MSc in Nurs

    Recruiting

Other trials in Hong Kong

About this study

Official title: An Online Pain Education Program for Working Adults: a Pilot Randomized Controlled Trial With One-month Follow-up

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.

Read the detailed description

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

  1. Inclusion criteria:
  2. . Age between 16 to 60;
  3. . Have a full-time job;
  4. . Resident of China;
  5. . Can read and understand Chinese;
  6. . History with non-cancer pain in past 6 months(Nicholas et al., 2013);
  7. . Pain score should be at least 2 when using Numeric Rating Scale, a 11-point numeric scale (Pieh et al., 2012);
  8. . Own a mobile phone and can access to mobile phone, computer and the internet.
  9. Exclusion criteria
  10. . Hospitalized patients;
  11. . Experiencing a drug addiction problem;
  12. . 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?"
Conditions
Chronic Pain
Being tested
Online pain education program
Keywords
Chronic pain, Working adults, Pain education, Internet-delivered
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online pain education programOther

    Online pain education program

Study groups in NCT03952910
Study groupRoleWhat they receive
Experimental groupExperimentalOnline pain education program will be accessible by the intervention group
Receives: Other: Online pain education program
Control groupNo interventionNo intervention for the control group, only one-page simple material related to pain will be provided.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain intensity and pain interference

    Changes from baseline to Week 4 and one-month after the intervention in pain intensity and pain interference using Brief Pain Inventory

    Measured: Baseline, Week 4, one-month after intervention

Secondary outcomes (3)
  1. Depression, Anxiety and Stress

    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.

    Measured: Baseline, Week 4, one-month after intervention

  2. Pain self-efficacy

    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.

    Measured: Baseline, Week 4, one-month after intervention

  3. Participant's Satisfaction and acceptability to the program

    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.

    Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2019
  2. Study start5 Jul 2019
  3. Primary completion5 Jul 2020 (estimated)
  4. Study completion5 Jul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03952910
Sponsor's protocol ID
OPEP
Status last verified
Aug 2019
First submitted
4 May 2019
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li Y, Tse MYM. An Online Pain Education Program for Working Adults: Pilot Randomized Controlled Trial. J Med Internet Res. 2020 Jan 14;22(1):e15071. doi: 10.2196/15071.

    PubMed 31934865

Questions about this trial

What is this clinical trial studying?

A study testing Online pain education program in people with Chronic Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mimi Tse, PhD (852-27666541, mimi.tse@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity and pain interference (time frame: Baseline, Week 4, one-month after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03952910, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.

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