COVID-19 PandemicCOVID19LATEXNCT05515276
The COVID-19 Pandemic Process Increase Latex Glove Use and Latex Allergy Complaints in Hospital Nurses? Survey Study
An observational study of COVID-19 Pandemic and Nurse's Role, run by Kilis 7 Aralik University at 1 site in Turkey (Türkiye).
Trial summary
Background: Global guidelines recommend the use of personal protective equipment due to the high risk of contagiousness of COVID-19 disease. The increase in COVİD-19 patients in the last two years has increased the rate of use of latex gloves in nurses. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic, Nurse's Role, Allergy
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Aug 2021
- How long will I take part?
- 2 Years
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The population of the study consisted of nurses working in Hatay Training and Research Hospital, and the sample consisted of nurses who met the inclusion criteria and volunteered to participate in the study. As a result of the research, 74.68% of the universe was reached. The sample size of the study was calculated in the G* Power 3.1.9.7 program, and a pyrori calculation was made according to the Mc Nemar test from the Exact test family. Cohen's d medium effect size was used in the calculation (Cohen J 1998). When the calculation is made such that odds ratio = 1.5, α error = 0.05, β error = 0.20, power = 0.80, effect size = 0.5 with the bidirectional hypothesis, the nurse to be sampled number was determined as N=398. The sample of the study (N=448) consisted of nurses.
Who may be able to join
- Over 18 years old
- Working as a nurse in Hatay Training and Research Hospital, Working in Hatay training and research hospital for the last month according to the date of the research
- Nurses who volunteered to participate in the study were included in the study.
Who cannot join
- Nurses who want to leave the study at any stage of the study after being included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Background: Global guidelines recommend the use of personal protective equipment due to the high risk of contagiousness of COVID-19 disease. The increase in COVİD-19 patients in the last two years has increased the rate of use of latex gloves in nurses. It is not known how the increase in the use of latex gloves affects the complaints of latex allergy in nurses.
Aim: The aim of this study is to determine the rates of latex glove use and allergic complaints related to the use of latex gloves during the COVID-19 pandemic in hospital nurses.
Read the detailed description
Background: Global guidelines recommend the use of personal protective equipment due to the high risk of contagiousness of COVID-19 disease. The increase in COVİD-19 patients in the last two years has increased the rate of use of latex gloves in nurses. It is not known how the increase in the use of latex gloves affects the complaints of latex allergy in nurses.
Aim: The aim of this study is to determine the rates of latex glove use and allergic complaints related to the use of latex gloves during the COVID-19 pandemic in hospital nurses.
Materials and Methods: Ethical and legal permissions were obtained before starting the research. Research; It was conducted in a descriptive and cross-sectional manner at Hatay Training and Research Hospital between May 15 and June 15, 2021. The sample of the study consisted of 448 nurses who volunteered to participate in the study. The data of the study were collected with data collection forms created by the researchers as a result of literature reviews. The data of the research were collected by the online questionnaire method. Analysis of the data was analyzed with appropriate statistical methods in SPSS 21.0 program. p<0.05 value was accepted for statistical significance.
- Conditions
- COVID-19 Pandemic, Nurse's Role, Allergy, Latex Allergy
- Keywords
- Latex Allergy, Latex Gloves, Corona virus disease, Nursing
- Medical subject headings
- COVID-19, Hypersensitivity, Latex Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying Information Form:
The identifying information form consists of questions aimed at determining the age, gender, education status, department of work, nursing experience, experience in the last working department, glove selection, family history of atopy, personal history of atopy, crossfood allergies, latex glove usage, duration of glove use in a day, number of invasive procedures, presence of diagnosed latex allergy, measures taken to prevent latex allergy, awareness of nonlatex gloves, and complaints after contact with latex-containing products.
Measured: 2023
Allergic Symptoms Evaluation Form:
The form consists of questions aimed at determining skin reactions and allergic symptoms such as itching, redness, swelling, hives, lesions, rash, contact dermatitis, swelling 7 around the mouth and throat, nasal discharge, itching, sneezing, itching, redness, watering of the eyes, shortness of breath, coughing, wheezing, fainting, feeling of faintness, loss of consciousness, thinking that existing symptoms are related to work, etc.
Measured: 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Jun 2021
- Primary completion1 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Kilis 7 Aralik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İslam Elagöz, Kilis 7 Aralik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515276
- Sponsor's protocol ID
- Kilis 7 Aralık Üniversitesi
- Acronym
- COVID19LATEX
- Status last verified
- Nov 2023
- First submitted
- 22 Aug 2022
- Last updated
- 29 Nov 2023
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COVID-19 Pandemic Process Increase Latex Glove Use and Latex Allergy Complaints in Hospital Nurses? Survey Study
- ClinicalTrials.gov ID
- NCT05515276
- Acronym / sponsor ID
- COVID19LATEX / Kilis 7 Aralık Üniversitesi
- Conditions
- COVID-19 Pandemic, Nurse's Role, Allergy, Latex Allergy
- Keywords
- Latex Allergy, Latex Gloves, Corona virus disease, Nursing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kilis 7 Aralik UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 25 Aug 2022 (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.
Background: Global guidelines recommend the use of personal protective equipment due to the high risk of contagiousness of COVID-19 disease. The increase in COVİD-19 patients in the last two years has increased the rate of use of latex gloves in nurses. It is not known how the increase in the use of latex gloves affects the complaints of latex allergy in nurses.
Aim: The aim of this study is to determine the rates of latex glove use and allergic complaints related to the use of latex gloves during the COVID-19 pandemic in hospital nurses.
Detailed description
Background: Global guidelines recommend the use of personal protective equipment due to the high risk of contagiousness of COVID-19 disease. The increase in COVİD-19 patients in the last two years has increased the rate of use of latex gloves in nurses. It is not known how the increase in the use of latex gloves affects the complaints of latex allergy in nurses.
Aim: The aim of this study is to determine the rates of latex glove use and allergic complaints related to the use of latex gloves during the COVID-19 pandemic in hospital nurses.
Materials and Methods: Ethical and legal permissions were obtained before starting the research. Research; It was conducted in a descriptive and cross-sectional manner at Hatay Training and Research Hospital between May 15 and June 15, 2021. The sample of the study consisted of 448 nurses who volunteered to participate in the study. The data of the study were collected with data collection forms created by the researchers as a result of literature reviews. The data of the research were collected by the online questionnaire method. Analysis of the data was analyzed with appropriate statistical methods in SPSS 21.0 program. p<0.05 value was accepted for statistical significance.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population of the study consisted of nurses working in Hatay Training and Research Hospital, and the sample consisted of nurses who met the inclusion criteria and volunteered to participate in the study. As a result of the research, 74.68% of the universe was reached. The sample size of the study was calculated in the G* Power 3.1.9.7 program, and a pyrori calculation was made according to the Mc Nemar test from the Exact test family. Cohen's d medium effect size was used in the calculation (Cohen J 1998). When the calculation is made such that odds ratio = 1.5, α error = 0.05, β error = 0.20, power = 0.80, effect size = 0.5 with the bidirectional hypothesis, the nurse to be sampled number was determined as N=398. The sample of the study (N=448) consisted of nurses.
Key inclusion criteria (3 listed)
- Over 18 years old
- Working as a nurse in Hatay Training and Research Hospital, Working in Hatay training and research hospital for the last month according to the date of the research
- Nurses who volunteered to participate in the study were included in the study.
Key exclusion criteria (1 listed)
- Nurses who want to leave the study at any stage of the study after being included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identifying Information Form:
Time frame: 2023
The identifying information form consists of questions aimed at determining the age, gender, education status, department of work, nursing experience, experience in the last working department, glove selection, family history of atopy, personal history of atopy, crossfood allergies, latex glove usage, duration of glove use in a day, number of invasive procedures, presence of diagnosed latex allergy, measures taken to prevent latex allergy, awareness of nonlatex gloves, and complaints after contact with latex-containing products.
Allergic Symptoms Evaluation Form:
Time frame: 2023
The form consists of questions aimed at determining skin reactions and allergic symptoms such as itching, redness, swelling, hives, lesions, rash, contact dermatitis, swelling 7 around the mouth and throat, nasal discharge, itching, sneezing, itching, redness, watering of the eyes, shortness of breath, coughing, wheezing, fainting, feeling of faintness, loss of consciousness, thinking that existing symptoms are related to work, etc.
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 29 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19 Pandemic and Nurse's Role, run by Kilis 7 Aralik University at 1 site in Turkey (Türkiye).
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 3 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 29 Nov 2023. 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 Turkey (Türkiye). 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?
Identifying Information Form: (time frame: 2023). The study lists 2 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 29 Nov 2023.