- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06791213
Effectiveness of the Digital Multimedia Health Education in Improving Cancer Pain, Analgesic Adherence, and Pain Control Satisfaction With Cancer Patient (EDICAP)
According to the International Association for the Study of Pain (IASP), pain is an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage . Despite advances in precision medicine, pain remains a common complaint among cancer patients, with 44.5% reporting pain and a 30.6% prevalence of moderate to severe pain. In Taiwan, over half of cancer patients experience pain in the week leading up to their outpatient visit, with 54% of oncology outpatients reporting pain issues. Of these, only 58% receive analgesics, with more medications given to those with worsening conditions. Pain significantly affects sleep, and over 50% of patients feel pain despite analgesic control. Research indicates that Asian patients often view cancer negatively, avoiding discussions about their condition, which normalizes their pain and potentially worsens it.
Enhancing patient self-efficacy can increase satisfaction with pain management, and it is recommended that healthcare professionals develop interventions to improve pain management satisfaction. Self-management interventions have shown effectiveness in improving pain-related knowledge and quality of life. These interventions can encompass patient attitudes and knowledge, with guidance and consultation from nurses reinforcing information about pain management and medication adherence.
In clinical settings, nurses may be too busy to provide comprehensive and consistent health education, leading to insufficient patient understanding of medications. Digital multimedia health education tools, which use visual aids, can better capture patients' attention and facilitate unrestricted learning regardless of time or place, leading to improved learning outcomes.
This study aims to investigate the effectiveness of "digital multimedia" in reducing pain, enhancing medication adherence, and improving pain control satisfaction among patients. The goal is to overcome the limitations of busy healthcare providers, allowing patients to learn independently, understand pain and analgesic use, dispel myths about pain medications, and enhance pain control, ultimately improving self-care capabilities, pain control satisfaction, and quality of life.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MINCHIA WENG
- Phone Number: 886-963-320-637
- Email: mjsmile0523@gmail.com
Study Locations
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-
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New Taipei City, Taiwan, 235
- 13F., No. 119, Ln. 136, Sec. 3, Zhongshan Rd., Zhonghe Dist., New Taipei City 235 , Taiwan (R.O.C.)
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Contact:
- MINCHIA WENG
- Phone Number: 0963320637
- Email: mjsmile0523@gmail.com
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Contact:
- MIN CHIA WENG
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged over 18 years.
- Diagnosed with a solid tumor and reporting a pain score of 4 or higher.
- Patients using prescribed strong opioid medications for pain management.
- Conscious, capable of communicating in Mandarin, understanding Mandarin, or -Able to write in text.
- Able to operate electronic devices (e.g., smartphones, tablets, or computers) independently, or with assistance from family members or caregivers.
Exclusion Criteria:
- Patients with visual or auditory impairments.
- Patients with cognitive impairments.
- Diagnosed by a physician as having substance addiction (addictive substances include central nervous system depressants: opioids, heroin, ketamine; central nervous system stimulants: amphetamines, ecstasy, cocaine; and central nervous system hallucinogens: cannabis).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
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Experimental: Treatment group
Digital Multimedia Health Education
|
This study aims to investigate the effectiveness of "digital multimedia" in reducing pain, enhancing medication adherence, and improving pain control satisfaction among patients.
The goal is to overcome the limitations of busy healthcare providers, allowing patients to learn independently, understand pain and analgesic use, dispel myths about pain medications, and enhance pain control, ultimately improving self-care capabilities, pain control satisfaction, and quality of life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cancer pain
Time Frame: From enrollment to the end of treatment at 12 weeks
|
This study defines its operational terms using the Taiwanese version of the Brief Pain Inventory (BPI-T).
Pain is assessed through the Numerical Rating Scale (NRS), which evaluates pain severity on a scale ranging from 0 to 10. Higher scores indic.
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From enrollment to the end of treatment at 12 weeks
|
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Analgesic Adherence
Time Frame: From enrollment to the end of treatment at 12 weeks
|
|
From enrollment to the end of treatment at 12 weeks
|
|
Pain Control Satisfaction
Time Frame: From enrollment to the end of treatment at 12 weeks
|
The Pain Treatment Satisfaction Scale (PTSS) was adopted for psychometric assessment and validation in patients with acute and chronic pain.
The scale evaluates various aspects, including pain severity, information about pain and its treatment, medication therapy, the effects of current pain medications, the route of administration, medication side effects, and satisfaction with current pain medications and overall care.
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From enrollment to the end of treatment at 12 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202407158RINE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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