- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07502131
Effect of the "EMS Back-Up" Ergonomic Program on Paramedics' Manual Handling Safety.
March 24, 2026 updated by: Taipei Medical University WanFang Hospital
Investigation on the Benefit of a Structured Manual Handling Training Program Regarding Paramedics' Technical Proficiency, Knowledge, and Behavioral Intentions on Clinical Practice Safety.
Effect of the "EMS Back-Up" Ergonomic Program on Paramedics' Manual Handling Safety.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Liang-Fu Chen
- Phone Number: +886963055751
- Email: chris2372660@gmail.com
Study Locations
-
-
-
Taipei, Taiwan, 116
- Recruiting
- Taipei Municipal Wanfang Hospital
-
Contact:
- Liang-Fu Liang-Fu Chen
- Phone Number: +8860963055751
- Email: chris2372660@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Frontline Emergency Medical Technicians (EMTs) or paramedics.
- Active duty personnel involved in patient handling and transport.
Exclusion Criteria:
- Non-frontline personnel (administrative only).
- Students or trainees not yet in clinical practice.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EMS Back-Up Training Group
|
A multi-modal training session including:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Score on the Standardized Manual Handling Checklist
Time Frame: Baseline (Pre-test) and Immediate Post-intervention (within 8 hours).
|
Technical proficiency is measured using the 9-item Standardized Manual Handling Checklist v3.0.
Each item is scored on a 3-point scale (0 = not achieved, 1 = partially achieved, 2 = fully achieved).
The total score is calculated by summing the scores of all 9 items, resulting in a range from 0 to 18.
A higher total score indicates a higher level of technical proficiency and safer manual patient handling performance.
|
Baseline (Pre-test) and Immediate Post-intervention (within 8 hours).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rated Perceived Exertion (RPE)
Time Frame: Baseline and Immediate Post-intervention.
|
Borg CR10 Scale (0-10), assessing the subjective physical effort during task execution.
|
Baseline and Immediate Post-intervention.
|
|
Score on the EMS Ergonomics and Safety Knowledge Test
Time Frame: Baseline and Immediate Post-intervention.
|
Theoretical knowledge is assessed via a 12-item multiple-choice and true/false questionnaire focusing on biomechanics, injury prevention, and the SAFE handling process.
Each correct answer is awarded 1 point.
The total score ranges from 0 to 12.
A higher score represents a greater understanding of occupational safety and ergonomic principles related to patient handling.
|
Baseline and Immediate Post-intervention.
|
|
Mean Score of Transtheoretical Model (TTM) Stages of Change
Time Frame: Baseline and Immediate Post-intervention.
|
Readiness for behavioral change is assessed using a 5-point scale corresponding to the TTM stages: 1 = Pre-contemplation, 2 = Contemplation, 3 = Preparation, 4 = Action, and 5 = Maintenance.
The result is reported as the mean stage score across 5 specific behavioral items (C1-C5).
The score ranges from 1 to 5, where a higher numerical value indicates a more advanced stage of readiness for adopting safe manual handling behaviors.
|
Baseline and Immediate Post-intervention.
|
|
Mean Score of Health Belief Model (HBM) Self-Efficacy Construct
Time Frame: Baseline and Immediate Post-intervention.
|
Perceived self-efficacy is measured using a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree) based on two specific items (D10, D11) regarding the ability to perform and lead safe handling techniques.
The outcome is the mean of these items, ranging from 1 to 5. A higher score reflects a higher level of confidence in performing safe manual handling tasks.
|
Baseline and Immediate Post-intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
March 17, 2026
First Submitted That Met QC Criteria
March 24, 2026
First Posted (Actual)
March 30, 2026
Study Record Updates
Last Update Posted (Actual)
March 30, 2026
Last Update Submitted That Met QC Criteria
March 24, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N202505088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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