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.
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
- Recruiting
School of Nursing
Hung Hom, Kowloon
Mimi Tse, PhD, 852-27666541, mimi.tse@polyu.edu.hk
YA JIE LI, MSc in Nurs
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:
- 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.
- 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?"
- 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 group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Online pain education program will be accessible by the intervention group Receives: Other: Online pain education program |
| Control group | No intervention | No 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.
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)
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
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
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.
- First posted16 May 2019
- Study start5 Jul 2019
- Primary completion5 Jul 2020 (estimated)
- Study completion5 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSE Mun Yee Mimi, The Hong Kong Polytechnic University
- Investigators
- Mimi Tse, PhD, Principal investigator, The Hong Kong Polytechnic University
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Pain Education Program for Working Adults: a Pilot Randomized Controlled Trial With One-month Follow-up
- ClinicalTrials.gov ID
- NCT03952910
- Acronym / sponsor ID
- OPEP
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Working adults, Pain education, Internet-delivered
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 5 Jul 2020 (estimated)
- Study completion
- 5 Jul 2020 (estimated)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants' eligibility will be accessed based on the following details:
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Online pain education programOnline pain education program will be accessible by the intervention group |
| Control group | No intervention | –No intervention for the control group, only one-page simple material related to pain will be provided. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- Hospitalized patients;
- Experiencing a drug addiction problem;
- Further medical and surgical treatments or interventions is planned.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online pain education programOnline pain education program | Other | Experimental group |
Primary outcome
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
3 secondary outcomes
Depression, Anxiety and Stress
Time frame: Baseline, Week 4, one-month after intervention
Pain self-efficacy
Time frame: Baseline, Week 4, one-month after intervention
Participant's Satisfaction and acceptability to the program
Time frame: Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Derived from this study: PubMed 31934865Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mimi Tse, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
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.