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Turkish Version of the Parent-Reported Drug Hypersensitivity Quality of Life Questionnaire

Validation and Reliability of the Turkish Version of the Parent-Reported Drug Hypersensitivity Quality of Life Questionnaire (P-DrHy-Q)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07069439
Enrollment
74
Registered
2025-07-16
Start date
2025-08-01
Completion date
2025-10-30
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy and Immunology, Caregivers, Drug Hypersensitivity, Quality of Life (QOL)

Brief summary

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.

Interventions

BEHAVIORALTurkish 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

Sponsors

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years * Primary caregiver of a child under the age of 18 * Child must have a documented history of drug hypersensitivity * Fluent in written and spoken Turkish * Willingness to participate and provide written informed consent * Availability to complete both baseline and follow-up questionnaire within the designated time frame

Exclusion criteria

* Caregivers with diagnosed psychiatric or cognitive disorders * Inability to read or write in Turkish * Child currently experiencing an acute drug hypersensitivity reaction * Previous participation in the pilot testing phase of this validation study

Design outcomes

Primary

MeasureTime frameDescription
Internal Consistency of the Turkish Version of the P-DrHy-QWithin 30 days from initial questionnaire administrationThe 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
Test-Retest Reliability of the Turkish P-DrHy-QFrom Day 1 to Day 15 (14-day interval between two administrations)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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026