GUR-HSQ: German Translation and Cross-cultural Adaptation of the Headache Screening Questionnaire (HSQ) Followed by a Test-retest Reliability Study.

Sponsor

Markus J. Ernst (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05893004

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this study is to learn more about the Headache Screening Questionnaire in people with Headache. The main question is:

Does the lower limit of a 95% confidence interval of the HSQ in physiotherapy during a period of 2 to 4 weeks reach at least 0.4?

Condition or Disease	Intervention/Treatment	Phase
Migraine Tension-Type Headache	Diagnostic Test: Headache Screening Questionnaire	N/A

Detailed Description

Data are collected using the REDCap web application (https://redcap.zhaw.ch/). REDCap is designed for the creation and administration of online surveys. Respondents can access the survey directly via a QR code or link and complete the screening questionnaire via smartphone or computer. In a first step, the participating persons are included or excluded based on the criteria mentioned (chapter: Proband:innen). Once eligibility has been confirmed, the HSQ is completed online for the first time in a second step. After that, the test persons will receive a reminder e-mail after 2 weeks to complete the retest online. After the reminder email the test persons have 2 weeks to complete the retest. Those who participate later will be excluded and not included in the data analysis. In addition, the retest asks whether the headaches have changed compared to the test due to the physiotherapeutic treatment. This is asked with a three Likert scale (not changed, slightly changed, strongly changed). The severely changed headaches are not included in the analysis.

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Study Design

Study Type:

Interventional

Anticipated Enrollment :

31 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

German Translation and Cross-cultural Adaptation of the Headache Screening Questionnaire (HSQ) Followed by a Test-retest Reliability Study.

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Outcome Measures

Primary Outcome Measures

Kappe Value [Participants are assessed based on criteria (chapter: participants). Eligible individuals complete the HSQ online. A reminder email is sent after 2 weeks for the retest. Participants have 2 weeks to complete it. Late participants are excluded from analys]
The HSQ uses nominal variables for screening the two primary headaches with defined cut-offs of 6 and 8 points for migraine and TTH, respectively. Therefore, for the test-retest reliability analysis, a Cohen's kappa with corresponding 95% confidence interval is calculated for both migraine and TTH.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Individuals who are older than 18 years,
live in Switzerland
speak and understand German
have had multiple headache episodes of the same or similar type

Exclusion Criteria:

individuals with other known neurological conditions,
known cognitive impairment
known secondary headache types

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Markus J. Ernst

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Markus J. Ernst, Phd., Zurich University of Applied Sciences

ClinicalTrials.gov Identifier:

NCT05893004

Other Study ID Numbers:

GUR-HSQ

First Posted:

Jun 7, 2023

Last Update Posted:

Jun 7, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tension-Type Headache

Headache

Study Results

No Results Posted as of Jun 7, 2023