Needle InjuryNCT06733779
Investigation and Analysis of the NIS Protection Level and Influencing Factors of Clinical Nurses
An observational study of Needle Injury, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
To investigate and analyze differences in the incidence of needle stick injuries and the influencing factors among clinical nurses in different economic regions. The online questionnaire survey was conducted by stratified and network sampling methods. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Needle Injury
- What is being tested?
- observation
- How many people
- 17,164 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2022to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- Adult
Study population: in-service and on-the-job clinical nurses working in tertiary hospitals
Who may be able to join
- cetificated nurse; voluntarily cooperated with the investigators;
Who cannot join
- nursing students,; nursing managers; individuals taking maternity leave due to pregnancy or childbirth; refusal to participate in the survey, questionnaire completion time not meeting the minimum requirement; reverse entry selections; incomplete responses.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
About this study
Official title: Investigation and Analysis of the NIS Protection Level and Influencing Factors of Clinical Nurses: a Large Population Sample Survey Based on China Economic Belt
To investigate and analyze differences in the incidence of needle stick injuries and the influencing factors among clinical nurses in different economic regions.
The online questionnaire survey was conducted by stratified and network sampling methods. A total of 17,164 questionnaires were collected, which included demographic characteristics of nurses; knowledge, beliefs, and behaviors related to needle injury protection of nurses; hospital management, training, and assessment of "needle injury" protocols. Additionally, the knowledge, beliefs, and behaviors of nurses in needle stick injuries were compared according to the economic region, and the correlation between influencing factors was analyzed.
Read the detailed description
Background: Needle stick injuries are a leading cause of occupational exposure in clinical nurse practice, with previous studies establishing that their incidence is typically lower in developed countries and affected by the local economic level. In China, significant differences in economic development levels exist between different regions. Based on the division of the economic region, this study investigated and analyzed differences in the incidence of needle stick injuries and the influencing factors among clinical nurses in different economic regions.
Methods:
The survey considered the level of economic development and regional characteristics. It included at least 5 tertiary hospitals from each provincial administrative unit, encompassing general hospitals, specialized hospitals, maternal and child health care hospitals, etc. Inclusion criteria for nurses: in-service and on-the-job clinical nurses working in tertiary hospitals holding valid nurse qualification certificates who voluntarily cooperated with the investigators. Exclusion criteria: nursing students, nursing managers, individuals taking maternity leave due to pregnancy or childbirth, refusal to participate in the survey, questionnaire completion time not meeting the minimum requirement, reverse entry selections, and incomplete responses. All study subjects were informed of the survey details in advance and signed the informed consent form before accessing the survey page.
Questionnaire This survey included a custom-made questionnaire entitled "Survey on the status of needle prick injuries in clinical nurses". It was designed by the researcher in collaboration with the experts of the clinical IV therapy team of the First Affiliated Hospital of Chongqing Medical University based on the "NSI protection expert consensus in 2018" [23] and was completed through four rounds of discussion and revisions. The expert group consisted of 13 members (including one statistical expert) distributed across five cities, seven general hospitals, and one medical college (statistical expert), among which 10 held senior titles and three held deputy senior titles. The questionnaire was reviewed by via four rounds of expert consultations from seven hospitals. Considering the influence of regional cultural differences in written expression, 268 pilot questionnaires were initially conducted in Chongqing (Western region), Guangdong (Southern region), and Hebei (Northern region) to further refine language and content. Finally, the questionnaire comprised three sections: 1. demographic characteristics of nurses, including region, hospital name, department name, age, years of experience, nursing role, nurse title, educational level, etc.; 2. Knowledge, belief, and behavior of nurses regarding NSI protection; 3. Hospital management, training, and assessment of the implementation of "NSI protection". The Kronbuck coefficient of the knowledge, belief, and behavior questionnaire was 0.789.
Based on the population data of each provincial administrative unit in 2021 [24], a stratified sampling method was employed based on a ratio of 1/100,000 population for each unit. The online questionnaire survey was distributed through an online survey software (Questionnaire Star) combined with an online sampling method. China Nursing Association is the only national nursing association organization for Nurses in China, with the Hospital Infection Management Committee of the Chinese Nursing Society being a subdivision of the organization. Its members are distributed in 28 provincial administrative units across the country, with over 800 members and 130 nursing department directors. This survey was officially published by the Hospital Infection Management Committee of the Chinese Nursing Society. Following approval of the survey notification information and questionnaire by the committee, the committee informed the liaison officers of the national hospital infection management committee to inform the head nurses of the hospital through the official WeChat working group, who in turn shared the questionnaire in the WeChat working groups of the department nurses. The notice asked the head nurse to emphasize the principle of voluntariness to the investigation object when sharing the questionnaire.
After the completion of the round of the survey, the researchers compiled completed statistics for each province and contacted liaison officers of local hospitals for the provinces that failed to meet the standards to launch a new round of data collection in the hospital. The survey was conducted from 8:00 on November 9, 2022, to 20:00 on February 16, 2023. Each round of surveys lasted 1 week.
Quality control When transcribing the questionnaire into an electronic format, two persons were accountable for logical consistency. To exclude invalid responses, a screening page was set, option quotas were established, the time for responses was controlled, and the answer input areas were restricted. Additionally, restrictions were imposed to allow login exclusively via WeChat, with each IP address and physical address limited to a single submission.
Data collection In order to ensure the integrity and reliability of the questionnaire, an informed consent page and explanation page were set up to detail the purpose and significance of the survey, as well as participant requirements, instructions, etc. The respondent could proceed with the questionnaire by selecting "agree to conduct the survey". The features of the questionnaire were as follows: 1. Set the questionnaire topic as the required topic; 2. requiring complete responses, with incomplete submissions being automatically rejected; 3. Setting the minimum time of completion to 5'20" according to the pre-survey, with submissions below this threshold automatically classified as invalid. A total of 17,164 questionnaires were collected, including 15,274 valid questionnaires, yielding an effective response rate of 89.89%.
Statistical method Categorical data were described as frequencies and rates, and group comparisons were performed using the chi-square test, with p-values adjusted using the S method for post-hoc pairwise comparisons. Measurement data following a normal distribution were presented mean ± standard deviation and compared using the two independent samples t-test or ANOVA, and post-hoc pairwise comparisons were conducted using the SNK-q test. Variables with P <0.05 in the univariate analysis were incorporated in a multivariate linear regression model to identify factors influencing the total score of the respondents and were screened using the stepwise selection method.
Variables with P <0.05 in the univariate analysis were incorporated in a multivariate linear regression model to identify factors influencing the total score of the respondents and were screened using the stepwise selection method with inclusion criteria for P <0.05 and exclusion for P ≥0.05.
The multiple mediation effect model was utilized to elucidate the association between economic regions and needle stick injury and to quantify the indirect and direct associations between economic regions through needle stick injury-related management, assessment, and training as mediating variables. In the present study, considering that multiple mediating variables were dichotomous variables, the indirect effects were challenging to directly measure. Therefore, the indirect effect size was quantified by the percentage of mediation (percentage mediated, PM), formula 1 minus the ratio of the direct effect (Direct effect, DE) to the total effect (Total effect, TE) multiplied by 100%: PM= (1-DE/TE) x 100%. This calculation was implemented using a partial macro program.
All statistical analyses were performed using SAS 9.4. P <0.05 was considered statistically significant.
- Conditions
- Needle Injury
- Being tested
- observation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
cross-sectional study
| Study group | Role | What they receive |
|---|---|---|
| Eastern region Western region | Located in eastern region of China Receives: Other: observation | |
| Centrel region | Located in the central region of China Receives: Other: observation | |
| Western region | Located in western region of China Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in the incidence of needle stick injuries and the influencing factors among clinical nurses in different economic regions.
to analyze the incidence rate in different regions and ralated influencing factors.
Measured: up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start9 Nov 2022
- Primary completion16 Feb 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Needle InjuryStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 17,164 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Ying, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Ying Shen, M.D, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733779
- Sponsor's protocol ID
- K2023-192
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shen Y, Liu G, Liu L, Yin Y, Tie H, Shao Y, Liu L, Pu K, Yao H, Jiang X, Wu L, Luo X, Tang W, He R. Regional differences and influencing factors of needlestick injury protection among clinical nurses in China: a national cross-sectional survey based on economic region. BMJ Open. 2026 Jul 29;16(7):e107635. doi: 10.1136/bmjopen-2025-107635.
PubMed 42526919Koy V, Preechawong S, Ear D, Phal S, Sok S, Coffey M, Murray JC. Identifying sterilization practice gaps at five early implementation hospitals in Cambodia: An observational study. Am J Infect Control. 2026 Mar;54(3):325-334. doi: 10.1016/j.ajic.2025.10.015. Epub 2025 Oct 28.
PubMed 41167476
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation and Analysis of the NIS Protection Level and Influencing Factors of Clinical Nurses: a Large Population Sample Survey Based on China Economic Belt
- ClinicalTrials.gov ID
- NCT06733779
- Acronym / sponsor ID
- K2023-192
- Conditions
- Needle Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,164 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 13 Dec 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.
To investigate and analyze differences in the incidence of needle stick injuries and the influencing factors among clinical nurses in different economic regions.
The online questionnaire survey was conducted by stratified and network sampling methods. A total of 17,164 questionnaires were collected, which included demographic characteristics of nurses; knowledge, beliefs, and behaviors related to needle injury protection of nurses; hospital management, training, and assessment of "needle injury" protocols. Additionally, the knowledge, beliefs, and behaviors of nurses in needle stick injuries were compared according to the economic region, and the correlation between influencing factors was analyzed.
Detailed description
Background: Needle stick injuries are a leading cause of occupational exposure in clinical nurse practice, with previous studies establishing that their incidence is typically lower in developed countries and affected by the local economic level. In China, significant differences in economic development levels exist between different regions. Based on the division of the economic region, this study investigated and analyzed differences in the incidence of needle stick injuries and the influencing factors among clinical nurses in different economic regions.
Methods:
The survey considered the level of economic development and regional characteristics. It included at least 5 tertiary hospitals from each provincial administrative unit, encompassing general hospitals, specialized hospitals, maternal and child health care hospitals, etc. Inclusion criteria for nurses: in-service and on-the-job clinical nurses working in tertiary hospitals holding valid nurse qualification certificates who voluntarily cooperated with the investigators. Exclusion criteria: nursing students, nursing managers, individuals taking maternity leave due to pregnancy or childbirth, refusal to participate in the survey, questionnaire completion time not meeting the minimum requirement, reverse entry selections, and incomplete responses. All study subjects were informed of the survey details in advance and signed the informed consent form before accessing the survey page.
Questionnaire This survey included a custom-made questionnaire entitled "Survey on the status of needle prick injuries in clinical nurses". It was designed by the researcher in collaboration with the experts of the clinical IV therapy team of the First Affiliated Hospital of Chongqing Medical University based on the "NSI protection expert consensus in 2018" [23] and was completed through four rounds of discussion and revisions. The expert group consisted of 13 members (including one statistical expert) distributed across five cities, seven general hospitals, and one medical college (statistical expert), among which 10 held senior titles and three held deputy senior titles. The questionnaire was reviewed by via four rounds of expert consultations from seven hospitals. Considering the influence of regional cultural differences in written expression, 268 pilot questionnaires were initially conducted in Chongqing (Western region), Guangdong (Southern region), and Hebei (Northern region) to further refine language and content. Finally, the questionnaire comprised three sections: 1. demographic characteristics of nurses, including region, hospital name, department name, age, years of experience, nursing role, nurse title, educational level, etc.; 2. Knowledge, belief, and behavior of nurses regarding NSI protection; 3. Hospital management, training, and assessment of the implementation of "NSI protection". The Kronbuck coefficient of the knowledge, belief, and behavior questionnaire was 0.789.
Based on the population data of each provincial administrative unit in 2021 [24], a stratified sampling method was employed based on a ratio of 1/100,000 population for each unit. The online questionnaire survey was distributed through an online survey software (Questionnaire Star) combined with an online sampling method. China Nursing Association is the only national nursing association organization for Nurses in China, with the Hospital Infection Management Committee of the Chinese Nursing Society being a subdivision of the organization. Its members are distributed in 28 provincial administrative units across the country, with over 800 members and 130 nursing department directors. This survey was officially published by the Hospital Infection Management Committee of the Chinese Nursing Society. Following approval of the survey notification information and questionnaire by the committee, the committee informed the liaison officers of the national hospital infection management committee to inform the head nurses of the hospital through the official WeChat working group, who in turn shared the questionnaire in the WeChat working groups of the department nurses. The notice asked the head nurse to emphasize the principle of voluntariness to the investigation object when sharing the questionnaire.
After the completion of the round of the survey, the researchers compiled completed statistics for each province and contacted liaison officers of local hospitals for the provinces that failed to meet the standards to launch a new round of data collection in the hospital. The survey was conducted from 8:00 on November 9, 2022, to 20:00 on February 16, 2023. Each round of surveys lasted 1 week.
Quality control When transcribing the questionnaire into an electronic format, two persons were accountable for logical consistency. To exclude invalid responses, a screening page was set, option quotas were established, the time for responses was controlled, and the answer input areas were restricted. Additionally, restrictions were imposed to allow login exclusively via WeChat, with each IP address and physical address limited to a single submission.
Data collection In order to ensure the integrity and reliability of the questionnaire, an informed consent page and explanation page were set up to detail the purpose and significance of the survey, as well as participant requirements, instructions, etc. The respondent could proceed with the questionnaire by selecting "agree to conduct the survey". The features of the questionnaire were as follows: 1. Set the questionnaire topic as the required topic; 2. requiring complete responses, with incomplete submissions being automatically rejected; 3. Setting the minimum time of completion to 5'20" according to the pre-survey, with submissions below this threshold automatically classified as invalid. A total of 17,164 questionnaires were collected, including 15,274 valid questionnaires, yielding an effective response rate of 89.89%.
Statistical method Categorical data were described as frequencies and rates, and group comparisons were performed using the chi-square test, with p-values adjusted using the S method for post-hoc pairwise comparisons. Measurement data following a normal distribution were presented mean ± standard deviation and compared using the two independent samples t-test or ANOVA, and post-hoc pairwise comparisons were conducted using the SNK-q test. Variables with P <0.05 in the univariate analysis were incorporated in a multivariate linear regression model to identify factors influencing the total score of the respondents and were screened using the stepwise selection method.
Variables with P <0.05 in the univariate analysis were incorporated in a multivariate linear regression model to identify factors influencing the total score of the respondents and were screened using the stepwise selection method with inclusion criteria for P <0.05 and exclusion for P ≥0.05.
The multiple mediation effect model was utilized to elucidate the association between economic regions and needle stick injury and to quantify the indirect and direct associations between economic regions through needle stick injury-related management, assessment, and training as mediating variables. In the present study, considering that multiple mediating variables were dichotomous variables, the indirect effects were challenging to directly measure. Therefore, the indirect effect size was quantified by the percentage of mediation (percentage mediated, PM), formula 1 minus the ratio of the direct effect (Direct effect, DE) to the total effect (Total effect, TE) multiplied by 100%: PM= (1-DE/TE) x 100%. This calculation was implemented using a partial macro program.
All statistical analyses were performed using SAS 9.4. P <0.05 was considered statistically significant.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eastern region Western region | – | Other: observationLocated in eastern region of China |
| Centrel region | – | Other: observationLocated in the central region of China |
| Western region | – | Other: observationLocated in western region of China |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- in-service and on-the-job clinical nurses working in tertiary hospitals
Key inclusion criteria (1 listed)
- cetificated nurse; voluntarily cooperated with the investigators;
Key exclusion criteria (1 listed)
- nursing students,; nursing managers; individuals taking maternity leave due to pregnancy or childbirth; refusal to participate in the survey, questionnaire completion time not meeting the minimum requirement; reverse entry selections; incomplete responses.
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 |
|---|---|---|
| observationcross-sectional study | Other | Centrel region, Eastern region Western region, Western region |
Primary outcome
differences in the incidence of needle stick injuries and the influencing factors among clinical nurses in different economic regions.
Time frame: up to 12 weeks.
to analyze the incidence rate in different regions and ralated influencing factors.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Derived from this study: PubMed 42526919Shen Y, Liu G, Liu L, Yin Y, Tie H, Shao Y, Liu L, Pu K, Yao H, Jiang X, Wu L, Luo X, Tang W, He R. Regional differences and influencing factors of needlestick injury protection among clinical nurses in China: a national cross-sectional survey based on economic region. BMJ Open. 2026 Jul 29;16(7):e107635. doi: 10.1136/bmjopen-2025-107635.
- Derived from this study: PubMed 41167476Koy V, Preechawong S, Ear D, Phal S, Sok S, Coffey M, Murray JC. Identifying sterilization practice gaps at five early implementation hospitals in Cambodia: An observational study. Am J Infect Control. 2026 Mar;54(3):325-334. doi: 10.1016/j.ajic.2025.10.015. Epub 2025 Oct 28.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ying Shen, M.D principal investigator
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Needle Injury, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
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: finished, as of the sponsor's last update on 13 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differences in the incidence of needle stick injuries and the influencing factors among clinical nurses in different economic regions. (time frame: up to 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06733779, which also lists 2 linked publications.
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 13 Dec 2024.