Nurse Based Care ManagementNCT06665009
How Nurses Use and Evaluate the Ampoule Peel Device: Comparing Manually Opened Vs. Device-Opened Ampoules
A study testing Manually Opened and Device-Opened Ampoules in people with Nurse Based Care Management, run by Chih-Cheng Wu at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurse Based Care Management
- What is being tested?
- Manually Opened and Device-Opened Ampoules
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Nov 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung
Chih Cheng Wu, Master, 886-4-23592525 ext. 4101, chihcheng.wu@gmail.com
Ruei-Ling Chen, 886-4-23592525 ext. 4135, gina811121@gmail.com
About this study
Official title: Utilization and Evaluation of Ampoule Peel Device
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.
Read the 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:
- 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.
- Conditions
- Nurse Based Care Management
- Being tested
- Manually Opened and Device-Opened Ampoules
- Keywords
- ampoule, ampoule peeling device, Device-Opened Ampoules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manually Opened and Device-Opened AmpoulesDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Manually Opened and Device-Opened | Experimental | Not described Receives: Device: Manually Opened and Device-Opened Ampoules |
What is being measured
The primary outcome is the main question the study is designed to answer.
events of injury
events times and sites of injury from different volumes of ampoules
Measured: through study completion, an average of 1 year
time efficiency
time spent needed to open ampules manually or by ampoule openers by seconds
Measured: 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".
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
ease of use
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"
Measured: through study completion, an average of 1 year
difficulty of operation
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"
Measured: through study completion, an average of 1 year
user satisfaction
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start29 Nov 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse Based Care ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chih-Cheng Wu
- Sponsor type
- University, hospital or other
- Collaborators
- Taichung Veterans General Hospital
- Responsible party
- Sponsor-investigator, Chih-Cheng Wu, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665009
- Sponsor's protocol ID
- CG24481A
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization and Evaluation of Ampoule Peel Device
- ClinicalTrials.gov ID
- NCT06665009
- Acronym / sponsor ID
- CG24481A
- Conditions
- Nurse Based Care Management
- Keywords
- ampoule, ampoule peeling device, Device-Opened Ampoules
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Chih-Cheng WuUniversity, hospital or other
- Collaborators
- Taichung Veterans General Hospital
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Manually Opened and Device-Opened | Experimental | Device: Manually Opened and Device-Opened Ampoules |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manually Opened and Device-Opened Ampoulesthis 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 | Device | Manually Opened and Device-Opened |
Primary outcome
events of injury
Time frame: through study completion, an average of 1 year
events times and sites of injury from different volumes of ampoules
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
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".
3 secondary outcomes
ease of use
Time frame: through study completion, an average of 1 year
difficulty of operation
Time frame: through study completion, an average of 1 year
user satisfaction
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
Related trials for Nurse Based Care Management
Recruiting
Nurse-Led Caregiver Support for Older Adults With Advanced Lung Cancer
Non-Small Cell Lung Cancer, Advanced Lung Cancer
Not yet recruitingObservational study
Implementing an Evidence-based, Standardized Care Bundle Targeting Register Nurses and Anaesthesiologists, to Enhance Patient Safety and Quality of Intravascular Access Devices Care Management - The Safe-IVADs Project. A Longitudinell Implementation Intervention With an Embedded Process Evaluation.
Phlebitis, Thrombophlebitis
Not yet recruiting
Effect of Nasogastric Tube Care Training by Simulation-Based and Video-Based Methods on Nurses' Confidence, Satisfaction, and Practices
Nurse Based Care Management, Nurse Led Interventions
Not yet recruiting
Medication Training Via Ignite Based on Roy Model in Heart Failure: Medication Adherence and Symptom Management
Hearth Failure With Reduced Ejection Fraction (HFrEF)
Recruiting
Immersive Virtual Reality for the Management of Anxiety Among Nurses
Anxiety, Nurse Based Care Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manually Opened and Device-Opened Ampoules in people with Nurse Based Care Management, run by Chih-Cheng Wu at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chih-Cheng Wu, Master (886-4-23592525 ext. 4116, chihcheng.wu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
events of injury (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.