An observational study in Drug Hypersensitivity, Quality of Life (QOL) and Caregivers, sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Observational
This study aims to evaluate the psychometric properties of the Turkish version of the Parent-reported Drug Hypersensitivity Quality of Life Questionnaire (P-DrHy-Q), a disease-specific instrument assessing the health-related quality of life (HRQoL) in caregivers of children with suspected or confirmed drug hypersensitivity reactions. The P-DrHy-Q is designed to capture the psychosocial burden experienced by caregivers and includes two main domains: Mental Health and Social Activity. This study involves a forward-backward translation process, cultural adaptation, internal consistency analysis, and test-retest reliability assessment in a Turkish caregiver population.
66 studies on the registry are indexed under Drug Hypersensitivity; 20 are open to participants now.
This study's enrollment of 74 is below the median of 200 across 28 observational studies indexed under Drug Hypersensitivity.
Browse Drug Hypersensitivity studies →Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization is the lead sponsor of 84 studies on the registry; 18 are open to participants now.
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The study population will consist of adult caregivers (parents or legal guardians) of children under the age of 18 who have a medically confirmed history of drug hypersensitivity. Participants will be recruited from a tertiary care pediatric allergy outpatient clinic. All participants must be fluent in Turkish and able to provide informed consent. The population represents a real-world sample of caregivers managing children with various types of drug allergies, including but not limited to reactions to antibiotics, antipyretics, and nonsteroidal anti-inflammatory drugs (NSAIDs). A subgroup of caregivers will be invited to complete the questionnaire twice to assess test-retest reliability.
Exclusion Criteria:
This cohort will consist of adult caregivers (parents or legal guardians) of children under 18 years of age with a documented history of drug hypersensitivity. Participants will complete the Turkish version of the Parent-reported Drug Hypersensitivity Quality of Life Questionnaire (P-DrHy-Q) to evaluate its psychometric properties, including internal consistency and test-retest reliability.
Behavioral: Turkish Version of the P-DrHy-Q
Participants will complete the Turkish-translated version of the Parent-reported Drug Hypersensitivity Quality of Life Questionnaire (P-DrHy-Q), which includes 12 items assessing psychosocial burden in two domains: mental health and social activity. A subgroup of participants (n ≈ 20) will complete the same questionnaire again after 14 days to assess test-retest reliability
Internal Consistency of the Turkish Version of the P-DrHy-Q
The internal consistency of the Turkish translation of the Parent-reported Drug Hypersensitivity Quality of Life Questionnaire (P-DrHy-Q) will be assessed. This analysis will evaluate the degree to which all items on the scale measure the same underlying construct (psychosocial burden in caregivers of children with drug hypersensitivity). Cronbach's alpha coefficient will be calculated for the total scale and its subscales (mental health and social activity).α ≥ 0.70 = Acceptable
Time frame: Within 30 days from initial questionnaire administration
Test-Retest Reliability of the Turkish P-DrHy-Q
This outcome assesses the stability of the Turkish version of the P-DrHy-Q over time in the absence of clinical change. Test-retest reliability ensures that the questionnaire produces consistent results when administered under similar conditions.A subset of 20 caregivers will complete the P-DrHy-Q a second time after 3 days. The Pearson correlation coefficient will be used to compare scores from the first and second administrations.r ≥ 0.70 = Good-Acceptable
Time frame: From Day 1 to Day 15 (14-day interval between two administrations)
Plan to share: No — This study does not plan to share individual participant data (IPD) due to the sensitive nature of patient and caregiver health information. All data will be analyzed and reported in aggregate form to protect participant confidentiality. Only authorized members of the research team will have access to the raw data, which will be stored securely in accordance with institutional and ethical guidelines.
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization