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NCT Number: NCT06665009

How Nurses Use and Evaluate the Ampoule Peel Device: Comparing Manually Opened Vs. Device-Opened Ampoules

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

  • 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.

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manually Opened and Device-Opened Ampoules

Device

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 outcomes

  1. events of injury

    Time frame: through study completion, an average of 1 year

    events times and sites of injury from different volumes of ampoules

  2. time efficiency

    Time frame: through study completion, an average of 1 year

    time spent needed to open ampules manually or by ampoule openers by seconds

  3. subjective estimation of safety

    Time frame: through study completion, an average of 1 year

    subjective estimation of safety by a scale out of a maximum score of 5, with 1 stands for "strongly disagree" and 5 stands for "strongly agree".

Secondary outcomes

  1. ease of use

    Time frame: through study completion, an average of 1 year

    subjective estimation of time-saving and difficulty by a scale out of a maximum score of 5, with 1 stands for "strongly disagree" and 5 stands for "strongly agree"

  2. difficulty of operation

    Time frame: through study completion, an average of 1 year

    subjective estimation of time-saving and difficulty by a scale out of a maximum score of 5, with 1 stands for "strongly disagree" and 5 stands for "strongly agree"

  3. user satisfaction

    Time frame: through study completion, an average of 1 year

    estimation of overall satisfaction rating (Out of a maximum score of 10, with 0 being very dissatisfied and 10 being very satisfied) for either open ampoules manually or by ampoule openers

Study contacts

Contact information is provided by the study sponsor or research team.

Chih-Cheng Wu, Master

CONTACT

[email protected]

886-4-23592525 ext. 4116

Ruei-Ling Chen

CONTACT

[email protected]

886-4-23592525 ext. 4135

Sponsors and collaborators

Lead sponsor

Chih-Cheng Wu

Other

Collaborators

  • Taichung Veterans General Hospital

Registry information

Official study title

Utilization and Evaluation of Ampoule Peel Device

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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