Clinical trial NCT03952910: An Online Pain Education Program for Working Adults
Official title: An Online Pain Education Program for Working Adults: a Pilot Randomized Controlled Trial With One-month Follow-up
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic pain
Working adults
Pain education
Internet-delivered
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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?"

Eligibility 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.

Primary outcomes:
measure: Pain intensity and pain interference
timeFrame: Baseline, Week 4, one-month after intervention
Secondary outcomes:
measure: Depression, Anxiety and Stress
timeFrame: Baseline, Week 4, one-month after intervention
measure: Pain self-efficacy
timeFrame: Baseline, Week 4, one-month after intervention
measure: Participant's Satisfaction and acceptability to the program
timeFrame: Week 4
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: School of Nursing
state: Kowloon
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Mimi Tse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.