NCT03952910

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2020

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

May 4, 2019

Last Update Submit

August 24, 2019

Conditions

Chronic Pain

Keywords

Chronic painWorking adultsPain educationInternet-delivered

Outcome Measures

Primary Outcomes (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

    Baseline, Week 4, one-month after intervention

Secondary Outcomes (3)

  • Depression, Anxiety and Stress

    Baseline, Week 4, one-month after intervention

  • Pain self-efficacy

    Baseline, Week 4, one-month after intervention

  • Participant's Satisfaction and acceptability to the program

    Week 4

Study Arms (2)

Experimental group

EXPERIMENTAL

Online pain education program will be accessible by the intervention group

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.

Interventions

Online pain education programOTHER

Online pain education program

Experimental group

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing

Hung Hom, Kowloon, Hong Kong

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31934865DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mimi Tse, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mimi Tse, PhD

CONTACT

852-27666541mimi.tse@polyu.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 4, 2019

First Posted

May 16, 2019

Study Start

July 5, 2019

Primary Completion

July 5, 2020

Study Completion

July 5, 2020

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)