NCT06675292

Brief Summary

Individuals with tension type headache

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

November 2, 2024

Last Update Submit

November 4, 2024

Conditions

Keywords

Headache Needs Assessment SurveyTension type headacheTurkish

Outcome Measures

Primary Outcomes (1)

  • Headache Needs Assessment Survey

    The Headache Needs Assessment consists of seven items that evaluate areas such as anxiety/worry, depression/discouragement, self-control, energy, functioning/work, family/social activities, and the overall impact of migraine. A unique aspect of the questionnaire is that it separates responses into two categories: (1) How often did this issue occur? (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Always); and (2) How much did this issue bother you? (1 = Not at all, 2 = A little, 3 = Somewhat, 4 = A lot, 5 = Very much). The total score ranges from 14 to 70, with higher scores indicating a greater negative impact on quality of life.

    through study completion, an average of 1 month

Secondary Outcomes (3)

  • Visual Analog Scale

    through study completion, an average of 1 month

  • Headache Impact Test-6 (HIT-6)

    through study completion, an average of 1 month

  • Henry Ford Hospital Headache Disability Inventory

    through study completion, an average of 1 month

Study Arms (1)

Individuals with tension type headache

Other: Survey-based study

Interventions

The demographic information of individuals with tension-type headaches, along with data from the Visual Analog Scale, Migraine Disability Assessment Questionnaire, Headache Impact Test-6, Henry Ford Hospital Headache Disability Inventory, and Headache Needs Assessment, will be collected and analyzed.

Individuals with tension type headache

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals with tension type headache

You may qualify if:

  • Having a diagnosis of tension-type headache,
  • Being between 18 and 65 years of age.

You may not qualify if:

  • Having a diagnosis of any headache disorder other than tension-type headache,
  • Having a history of any systemic disease, such as malignancy, inflammatory conditions, acute fractures, surgical history, or neurological, psychological, or rheumatological disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpaşa University

Tokat Province, 60250, Turkey (Türkiye)

Location

Related Publications (1)

  • Arikan H, Onan D, Kulu U. Psychometric properties of the headache needs assessment (HANA) survey in tension type headache: Turkish version, reliability, and validity study. Acta Neurol Belg. 2025 Aug;125(4):1091-1099. doi: 10.1007/s13760-025-02749-4. Epub 2025 Feb 24.

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Halime ARIKAN, Doctor of Philosophy

    Tokat Gaziosmanpaşa University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 2, 2024

First Posted

November 5, 2024

Study Start

October 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

November 5, 2024

Record last verified: 2024-11

Locations