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An Online Pain Education Program for Working Adults

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Online pain education program
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring Chronic pain, Working adults, Pain education, Internet-delivered

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • School of NursingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Online pain education program will be accessible by the intervention group

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 4, 2019
Last Updated
August 24, 2019
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT03952910
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
July 5, 2020 (Anticipated)
Study Completion Date
July 5, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: . 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?"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pain, Working adults, Pain education, Internet-delivered

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Online pain education program will be accessible by the intervention group
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention for the control group, only one-page simple material related to pain will be provided.
Intervention Type
Other
Intervention Name(s)
Online pain education program
Intervention Description
Online pain education program
Primary Outcome Measure Information:
Title
Pain intensity and pain interference
Description
Changes from baseline to Week 4 and one-month after the intervention in pain intensity and pain interference using Brief Pain Inventory
Time Frame
Baseline, Week 4, one-month after intervention
Secondary Outcome Measure Information:
Title
Depression, Anxiety and Stress
Description
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.
Time Frame
Baseline, Week 4, one-month after intervention
Title
Pain self-efficacy
Description
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.
Time Frame
Baseline, Week 4, one-month after intervention
Title
Participant's Satisfaction and acceptability to the program
Description
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.
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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; 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. Exclusion Criteria: Hospitalized patients; Experiencing a drug addiction problem; Further medical and surgical treatments or interventions is planned.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mimi Tse, PhD
Phone
852-27666541
Email
mimi.tse@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mimi Tse, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing
City
Hung Hom
State/Province
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mimi Tse, PhD
Phone
852-27666541
Email
mimi.tse@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
YA JIE LI, MSc in Nurs

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31934865
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.
Results Reference
derived

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An Online Pain Education Program for Working Adults

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