HeadacheNCT06125821
Arabic Version Of Henry Ford Hospital Headache Disability Inventory Questionnaire : Validity, And Reliability
An observational study of Headache, run by Cairo University.
Trial summary
ARABIC VERSION OF HENRY FORD HOSPITAL HEADACHE DISABILITY INVENTORY QUESTIONNAIRE: CROSS-CULTURAL ADAPTATION, VALIDITY, AND RELIABILITY Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache
- What is being tested?
- questionnaire
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Nov 2024
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: In order to select the participants, researchers will examine the patients who referred to the hospital over a 3-month period and selected those diagnosed with chronic primary headache to enter the study.
Who may be able to join
- Chronic primary headache to enter the study.
- Patients having chronic daily headaches at least 15 days a month.
Who cannot join
- Patients with secondary headaches who has underlying serious problems (infection, trauma, tumors, and brain bleedings)
- Severe psychotic and mental dysfunctions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Arabic Version Of Henry Ford Hospital Headache Disability Inventory Questionnaire : Cross Cultural Adaptation, Validity, And Reliability
ARABIC VERSION OF HENRY FORD HOSPITAL HEADACHE DISABILITY INVENTORY QUESTIONNAIRE: CROSS-CULTURAL ADAPTATION, VALIDITY, AND RELIABILITY
Read the detailed description
This questionnaire will be developed to assess the impact of headache on functional and emotional aspects of daily life. The Alpha version of HDI (alpha-HDI) included 40 items, but the newest Beta version (beta-HDI) contains 25 items. The Beta version of HDI, developed by Jacobson (1994) in English, is a generic headache disability questionnaire widely administered in the related research studies.
This questionnaire measures the effect of different medical and rehabilitation treatments on the physical and emotional disabilities in patients with different types of headaches. This generic headache questionnaire is not specific to any headache type. Therefore, HDI will be applied to follow the general consequences of different headache types and to compare different aspects of disability for a variety of headaches. Based on the literature, the original HDI has strong internal consistency/reliability and construct validity. The results of test-retest showed that HDI has an acceptable level of reliability considering the total questionnaire and its subscale scores.
The validity and reliability of the non-English versions of HDI, such as Spanish, have been previously investigated and confirmed. The Arabic researchers and practitioners need valid and reliable tools to measure the emotional and functional states of patients with different headache disorders.
So, This study will be carried out to translate and culturally adapt the HDI questionnaire for administration among the Egyptian patients with headaches. Moreover, This study will assess the validity and reliability of the developed Arabic version of this questionnaire. Creation of questionnaires in different languages must pass through many steps. Questionnaires must be translated, then culturally adapted to the environment in which they will be used.
- Conditions
- Headache
- Being tested
- questionnaire
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
questionnaire
| Study group | Role | What they receive |
|---|---|---|
| questionnaire | Arabic Version Of Henry Ford Hospital Headache Disability Inventory Questionnaire : Cross Cultural Adaptation, Validity, And Reliabilit Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arabic Version Of Henry Ford Hospital Headache Disability Inventory Questionnaire : Cross Cultural Adaptation, Validity, And Reliability
This study will be carried out to translate and culturally adapt the Henry ford inventory questionnaire for administration among the Egyptian patients with headaches.
Measured: 4 month
Arabic Version Of Henry Ford Hospital Headache Disability Inventory Questionnaire : Cross Cultural Adaptation, Validity, And Reliability
This study will assess the validity and reliability of the developed Arabic version of this questionnaire.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Apr 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Ali Mohamed Abd Alghani, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125821
- Sponsor's protocol ID
- Arabic Version questionnaire
- Status last verified
- Feb 2024
- First submitted
- 28 Sep 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arabic Version Of Henry Ford Hospital Headache Disability Inventory Questionnaire : Cross Cultural Adaptation, Validity, And Reliability
- ClinicalTrials.gov ID
- NCT06125821
- Acronym / sponsor ID
- Arabic Version questionnaire
- Conditions
- Headache
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 9 Nov 2023 (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.
ARABIC VERSION OF HENRY FORD HOSPITAL HEADACHE DISABILITY INVENTORY QUESTIONNAIRE: CROSS-CULTURAL ADAPTATION, VALIDITY, AND RELIABILITY
Detailed description
This questionnaire will be developed to assess the impact of headache on functional and emotional aspects of daily life. The Alpha version of HDI (alpha-HDI) included 40 items, but the newest Beta version (beta-HDI) contains 25 items. The Beta version of HDI, developed by Jacobson (1994) in English, is a generic headache disability questionnaire widely administered in the related research studies.
This questionnaire measures the effect of different medical and rehabilitation treatments on the physical and emotional disabilities in patients with different types of headaches. This generic headache questionnaire is not specific to any headache type. Therefore, HDI will be applied to follow the general consequences of different headache types and to compare different aspects of disability for a variety of headaches. Based on the literature, the original HDI has strong internal consistency/reliability and construct validity. The results of test-retest showed that HDI has an acceptable level of reliability considering the total questionnaire and its subscale scores.
The validity and reliability of the non-English versions of HDI, such as Spanish, have been previously investigated and confirmed. The Arabic researchers and practitioners need valid and reliable tools to measure the emotional and functional states of patients with different headache disorders.
So, This study will be carried out to translate and culturally adapt the HDI questionnaire for administration among the Egyptian patients with headaches. Moreover, This study will assess the validity and reliability of the developed Arabic version of this questionnaire. Creation of questionnaires in different languages must pass through many steps. Questionnaires must be translated, then culturally adapted to the environment in which they will be used.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| questionnaire | – | Other: questionnaireArabic Version Of Henry Ford Hospital Headache Disability Inventory Questionnaire : Cross Cultural Adaptation, Validity, And Reliabilit |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In order to select the participants, researchers will examine the patients who referred to the hospital over a 3-month period and selected those diagnosed with chronic primary headache to enter the study.
Key inclusion criteria (2 listed)
- Chronic primary headache to enter the study.
- Patients having chronic daily headaches at least 15 days a month.
Key exclusion criteria (2 listed)
- Patients with secondary headaches who has underlying serious problems (infection, trauma, tumors, and brain bleedings)
- Severe psychotic and mental dysfunctions
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 |
|---|---|---|
| questionnairequestionnaire | Other | questionnaire |
Primary outcome
Arabic Version Of Henry Ford Hospital Headache Disability Inventory Questionnaire : Cross Cultural Adaptation, Validity, And Reliability
Time frame: 4 month
This study will be carried out to translate and culturally adapt the Henry ford inventory questionnaire for administration among the Egyptian patients with headaches.
Arabic Version Of Henry Ford Hospital Headache Disability Inventory Questionnaire : Cross Cultural Adaptation, Validity, And Reliability
Time frame: 4 month
This study will assess the validity and reliability of the developed Arabic version of this questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
Related trials for Headache
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, run by Cairo University.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact samah Ali (+201274870063, samahaliadam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arabic Version Of Henry Ford Hospital Headache Disability Inventory Questionnaire : Cross Cultural Adaptation, Validity, And Reliability (time frame: 4 month). 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 6 Feb 2024.