How Nurses Use and Evaluate the Ampoule Peel Device: Comparing Manually Opened Vs. Device-Opened Ampoules
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Manually Opened and Device-Opened Ampoules.
- Who it may be relevant to
- Registry conditions: Nurse Based Care Management. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Utilization and Evaluation of Ampoule Peel Device
Overview
Nurses frequently handle ampoule bottles in their daily work, and due to the fragile nature of these glass bottles, manual opening often leads to hand injuries. According to studies, a high proportion of occupational injuries among nurses are caused by handling ampoule bottles, especially hand lacerations. These injuries not only affect work efficiency but also increase medical risks. Therefore, to improve safety and reduce occupational injuries, this study aims to evaluate a patented ampoule peeling device, which has also won the National Innovation Award, to assess whether it can enhance the safety and satisfaction of nurses during their work.
Detailed description
The primary objective of this study is to evaluate the ampoule peeling device in terms of safety, ease of use, time efficiency, difficulty of operation, and user satisfaction among nurses when opening ampoule bottles of different capacities. A key focus is to determine whether the device can reduce the risk of hand injuries and improve work efficiency.
Study Design and Procedures:
The study will be conducted in three phases:
1. Phase 1 (Experimental Study):
In a quiet and controlled environment, nurses will manually and using the ampoule peeling device, open different sizes of ampoule bottles (1ml, 2ml, 5ml, 10ml). Each participant will record the time required, safety, difficulty, success rate, and any incidents of hand injuries during the process. After completing both methods, participants will fill out subjective evaluation forms to assess their satisfaction with each method. 2. Phase 2 (Observational Study):
Nurses participating in Phase 1 will record the number of ampoule bottles they manually open over five consecutive days, noting the success rate and any hand injuries. Then, they will use the ampoule peeling device for the next five days and record similar data for comparison. 3. Phase 3 (Observational Study):
After Phase 2, participants will have the freedom to choose between manual or device-assisted methods for a six-month period. At the end of this period, they will complete a survey summarizing their reasons for choosing a method, usage frequency, and overall safety and satisfaction levels.
Expected Outcomes:
It is anticipated that the ampoule peeling device will significantly improve safety, ease of use, and user satisfaction compared to manual methods. While there may not be a statistically significant difference in time efficiency, the overall success rate and safety should be enhanced.
Interventions
- Device Manually Opened and Device-Opened Ampoules
this study is to evaluate the ampoule peeling device in terms of safety, ease of use, time efficiency, difficulty of operation, and user satisfaction among nurses when opening ampoule bottles of different capacities
Primary outcome measures
- events of injury [Time frame: through study completion, an average of 1 year]
- time efficiency [Time frame: through study completion, an average of 1 year]
- subjective estimation of safety [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (3)
- ease of use [Time frame: through study completion, an average of 1 year]
- difficulty of operation [Time frame: through study completion, an average of 1 year]
- user satisfaction [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 16 nursing staff members from W72, W75, and the Department of Anesthesiology, who passed the preliminary tests and are willing to continue to the subsequent phases
Exclusion criteria
- Nursing staff unwilling to participate, unable to manually break ampoules, experiencing difficulty during the preparatory phase, or deciding to discontinue or withdraw during the process.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Taiwan · 1 center
- Taichung Veterans General Hospital — Taichung
Identifiers
NCT: NCT06665009 · CG24481A