Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
Healthy Volunteers
ID06665009

Utilization and Evaluation of Ampoule Peel Device to Improve Nurse Safety and Satisfaction

Led by Chih-Cheng Wu · Updated on 2024-12-09

16

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

C

Chih-Cheng Wu

Lead Sponsor

T

Taichung Veterans General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Nurses often handle fragile glass ampoule bottles in their daily work, which can lead to hand injuries like cuts when opening them manually. These injuries can reduce work efficiency and increase health risks. This research aims to evaluate a patented ampoule peeling device, which has won the National Innovation Award, to see if it can improve safety and satisfaction for nurses during their tasks. The study is carried out in three phases. First, nurses will open different sizes of ampoule bottles manually and with the peeling device in a controlled setting, measuring time, safety, difficulty, success, and any hand injuries. Next, over ten days, participants will track their manual and device-assisted ampoule openings and related injuries. Finally, nurses can choose their preferred method for six months and complete a survey on usage frequency, safety, and satisfaction. Participants will record details such as injury events, time efficiency, and subjective safety over about one year. They will also evaluate ease of use, difficulty, and overall satisfaction. The study collects data through timed tasks, injury tracking, and questionnaires to assess whether the device offers improvements compared to manual opening methods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Nursing staff members from W72, W75, and the Department of Anesthesiology
  • Passed preliminary tests and willing to continue to subsequent study phases
  • Aged 20 years or older
  • Able to manually open ampoule bottles without difficulty
  • Willing to participate in all stages of the study
Not Eligible

You will not qualify if you...

  • Nursing staff unwilling to participate
  • Unable to manually open ampoules
  • Experiencing difficulty during the preparatory phase
  • Deciding to discontinue or withdraw during the study process

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - 1 day or session

Participants manually and with the ampoule peeling device open different sizes of ampoule bottles in a controlled environment to evaluate safety, ease of use, time efficiency, difficulty, and satisfaction.

1 visit (in-person)

Monitoring

Duration - 10 days

Participants record manual opening of ampoules for 5 consecutive days, then use the device for the next 5 days to compare success rates and hand injuries.

Daily self-recording over 10 days

Long-term Monitoring

Duration - 6 months

Participants choose their preferred method (manual or device-assisted) and use it over a six-month period, then complete a survey on usage, safety, and satisfaction.

1 survey completion visit at the end of 6 months

Trial Site Locations

Total: 1 location

1

Taichung Veterans General Hospital

Taichung, Taiwan

Actively Recruiting

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Research Team

C

Chih-Cheng Wu, Master

R

Ruei-Ling Chen

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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