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

NCT06665009 | Recruiting

• 1 other identifier: CG24481A
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Nurse Based Care Management

Keywords

ampoule; ampoule peeling device; Device-Opened Ampoules

Outcome Measures

Primary Outcomes (3)

• events of injury

  events times and sites of injury from different volumes of ampoules

  through study completion, an average of 1 year

• time efficiency

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

  through study completion, an average of 1 year

• subjective estimation of safety

  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".

  through study completion, an average of 1 year

Secondary Outcomes (3)

• ease of use

  through study completion, an average of 1 year

• difficulty of operation

  through study completion, an average of 1 year

• user satisfaction

  through study completion, an average of 1 year

Study Arms (1)

Manually Opened and Device-Opened

EXPERIMENTAL

Device: Manually Opened and Device-Opened Ampoules

Interventions

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

Manually Opened and Device-Opened

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chih-Cheng Wu: lead
• Taichung Veterans General Hospital: collaborator

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

RECRUITING

Central Study Contacts

Chih-Cheng Wu, Master

CONTACT

886-4-23592525; chihcheng.wu@gmail.com

Ruei-Ling Chen

CONTACT

886-4-23592525; gina811121@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: head, Department of Pain Management, Taichung Veterans General hospital

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 30, 2024
• Study Start: November 29, 2024
• Primary Completion: August 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-10

Locations

TW (1)