NCT05515276

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

August 22, 2022

Last Update Submit

November 23, 2023

Conditions

Keywords

Latex AllergyLatex GlovesCorona virus diseaseNursing

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2023

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Nurses who want to leave the study at any stage of the study after being included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Islam

Kilis, 79100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19HypersensitivityLatex Hypersensitivity

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 25, 2022

Study Start

June 1, 2021

Primary Completion

July 1, 2021

Study Completion

August 1, 2021

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations