Drug HypersensitivityNCT07069439
Turkish Version of the Parent-Reported Drug Hypersensitivity Quality of Life Questionnaire
An observational study of Drug Hypersensitivity and Quality of Life (QOL), run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Drug Hypersensitivity, Quality of Life (QOL), Caregivers
- What is being tested?
- Turkish Version of the P-DrHy-Q
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Istanbul
About this study
Official title: Validation and Reliability of the Turkish Version of the Parent-Reported Drug Hypersensitivity Quality of Life Questionnaire (P-DrHy-Q)
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.
- Being tested
- Turkish Version of the P-DrHy-Q
- Medical subject headings
- Drug Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Version of the P-DrHy-QBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Turkish Version of the P-DrHy-Q |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From Day 1 to Day 15 (14-day interval between two administrations)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Aug 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Gungor, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069439
- Sponsor's protocol ID
- 2025-300613
- Other IDs
- 2025
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Reliability of the Turkish Version of the Parent-Reported Drug Hypersensitivity Quality of Life Questionnaire (P-DrHy-Q)
- ClinicalTrials.gov ID
- NCT07069439
- Acronym / sponsor ID
- 2025-300613
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregiver Cohort | – | Behavioral: Turkish Version of the P-DrHy-QThis 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkish Version of the P-DrHy-QParticipants 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 | Behavioural | Caregiver Cohort |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Hypersensitivity and Quality of Life (QOL), run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal Consistency of the Turkish Version of the P-DrHy-Q (time frame: Within 30 days from initial questionnaire administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.