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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04252326
Other study ID # DrNazli2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date March 1, 2020

Study information

Verified date September 2020
Source Saglik Bilimleri Universitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Adverse drug reactions are an important public health consern that affects physician prescriptions and practice. The responsibilities of healthcare professionals in monitoring, prevention, treatment and reporting of drug hypersensitivity reactions and drug allergies are essential for patient safety. Providing drug safety must be one of the main goals to be achieved for every member of our society. In our study, we planned to evaluate the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patients and to determine the risk factors that may affect them.


Description:

This study was carried out in a capital-located university hospital with a capacity of 1150 beds. Healthcare workers who are authorized to intervene in children (0-18 age group) including medical doctors, nurses and dentists were enrolled to study. In the evaluation of the knowledge, attitudes, and behaviors of the participants about drug hypersensitivity reactions in children, a study questionnaire was developed by pediatric allergy and immunology specialists and pediatric nurses by considering the other studies on the same subject.


Recruitment information / eligibility

Status Completed
Enrollment 354
Est. completion date March 1, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

The study included healthcare workers including medical doctors, nurses and dentists who perform interventions on children (0-18 years of age).

Exclusion Criteria:

-

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Survey
Doctors, Nurses and Dentists filled survey about adverse drug reractions

Locations

Country Name City State
Turkey Health Sciences University, Gülhane Training and Research Hospital, Gn. Dr. Tevfik Saglam Cd No:11 Ankara Etlik

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Dorji C, Tragulpiankit P, Riewpaiboon A, Tobgay T. Knowledge of Adverse Drug Reaction Reporting Among Healthcare Professionals in Bhutan: A Cross-Sectional Survey. Drug Saf. 2016 Dec;39(12):1239-1250. — View Citation

Seid MA, Kasahun AE, Mante BM, Gebremariam SN. Healthcare professionals' knowledge, attitude and practice towards adverse drug reaction (ADR) reporting at the health center level in Ethiopia. Int J Clin Pharm. 2018 Aug;40(4):895-902. doi: 10.1007/s11096-0 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary we planned to evaluate the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patients The knowledge level domain, consisted of 24 questions including mechanism of drug hypersensitivity reactions, clinical findings, diagnosis and treatment. The answer format was 3 options (yes/no /don't know). A triple variable scale was used for knowledge level (0 to 2: 0, false; 1, true; 2, do not know).
The attitude domain consisted of 5 questions including the effect of DHRs on the patient's quality of life and advanced training and current diagnostic tests for the needs in this regard. A five-point Likert-type scale was used for the questions to determine the level of agreement or disagreement (1 to 5; 1 strongly disagree; 2, disagree; 3, uncertain; 4, agree; 5, strongly agree)
The practice domain consisted of 9 questions including taking history and practice in drug allergy and advanced training in DHR. A Likert-type scale was used to determine the level of practices (1 - 5: 1, never; 2, very rarely; 3, sometimes; 4, often; 5, always).
It is planned to fill the questionnaire in 2 hours.
Primary we planned to evaluate the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patients The knowledge level domain, consisted of 24 questions including mechanism of drug hypersensitivity reactions, clinical findings, diagnosis and treatment. The answer format was 3 options (yes/no /don't know).
2. The attitude domain consisted of 5 questions including the effect of DHRs on the patient's quality of life and advanced training and current diagnostic tests for the needs in this regard. A five-point Likert-type scale was used for the questions to determine the level of agreement or disagreement The practice domain consisted of 9 questions including taking history and practice in drug allergy and advanced training in DHR. A Likert-type scale was used to determine the level of practices
It is planned to fill the questionnaire in 2 hours.
Secondary to determine the risk factors that may affect the knowledge, attitudes, and behaviors of healthcare workers in our country about drug hypersensitivity reactions in pediatric patient Participants'demographic questions regarding the age, gender, profession, duration in the profession, title and educational status of the participants may effect their surveys scores It is planned to fill the questionnaire in 2 hours.
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