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

NCT07069439 | Completed

• 1 other identifier: 2025-300613
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  From Day 1 to Day 15 (14-day interval between two administrations)

Study Arms (1)

Caregiver Cohort

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

Interventions

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

Caregiver Cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Drug Hypersensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Pediatric Immunology and Allergy

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: August 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)