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

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.

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Key information

Conditions

Drug Hypersensitivity Allergy and Immunology Caregivers Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Hypersensitivity Immune System Diseases Quality of Life (QOL)

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Turkish Version of the P-DrHy-Q

Behavioral

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

Primary outcomes

Internal Consistency of the Turkish Version of the P-DrHy-Q

Time frame: Within 30 days from initial questionnaire administration

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
Test-Retest Reliability of the Turkish P-DrHy-Q

Time frame: From 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

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jul 16, 2025
Registry last updated: Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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