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

NCT ID: NCT06665009

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-29

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Nurse Based Care Management

Keywords

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ampoule ampoule peeling device Device-Opened Ampoules

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Manually Opened and Device-Opened

Group Type EXPERIMENTAL

Manually Opened and Device-Opened Ampoules

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role collaborator

Chih-Cheng Wu

OTHER

Sponsor Role lead

Responsible Party

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Chih-Cheng Wu

head, Department of Pain Management, Taichung Veterans General hospital

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chih-Cheng Wu, Master

Role: CONTACT

Phone: 886-4-23592525

Email: [email protected]

Ruei-Ling Chen

Role: CONTACT

Phone: 886-4-23592525

Email: [email protected]

Facility Contacts

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Chih Cheng Wu, Master

Role: primary

Ruei-Ling Chen

Role: backup

Chih Cheng Wu, Master

Role: backup

Other Identifiers

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CG24481A

Identifier Type: -

Identifier Source: org_study_id