Clinical trial NCT06665009: How Nurses Use and Evaluate the Ampoule Peel Device: Comparing Manually Opened Vs. Device-Opened Ampoules
Official title: Utilization and Evaluation of Ampoule Peel Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nurse Based Care Management
Keywords: ampoule
ampoule peeling device
Device-Opened Ampoules
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
Collaborators: name: Taichung Veterans General Hospital
First posted: 2024-10-30
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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.

Primary outcomes:
measure: events of injury
timeFrame: through study completion, an average of 1 year
measure: time efficiency
timeFrame: through study completion, an average of 1 year
measure: subjective estimation of safety
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: ease of use
timeFrame: through study completion, an average of 1 year
measure: difficulty of operation
timeFrame: through study completion, an average of 1 year
measure: user satisfaction
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References: