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

NCT ID: NCT07069439

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Turkish Version of the P-DrHy-Q

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role lead

Responsible Party

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Hilal Gungor

Medical Doctor, Pediatric Immunology and Allergy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2025-300613

Identifier Type: -

Identifier Source: org_study_id

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