The Relationship Between Obesity and Chronic Headache | NCT06445595

Studies
The Relationship Between Obesity and Chronic Headache

NCT06445595

Sponsor

Karaman Training and Research Hospital

Status

Unknown status

Last Update Posted

Oct 15, 2024Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Traumatic Brain Injury

Interventions

patients with traumatic brain injury

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2024Actual

Primary Completion Date

Oct 1, 2025Estimated

Completion Date

Jan 31, 2026Estimated

First Submitted Date

May 31, 2024

First Submission Date that Met QC Criteria

May 31, 2024

First Posted Date

Jun 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2024

Last Update Posted Date

Oct 15, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

HATİCE TOPRAK, asst. prof, Karaman Training and Research HospitalPrincipal Investigator

Lead Sponsor

Karaman Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The relationship between obesity and the development of chronic headache after traumatic brain injury will be investigated.

Detailed Description

Traumatic brain injury (TBI) can be defined as an injury caused by an external force, particularly a direct blow to the head or exposure to a shock wave. In addition to the well-known consequences of TBI, including cognitive changes, motor deficits and sensory abnormalities, available evidence suggests that acute and chronic pain is also common after TBI. Obesity and TBI can be considered as public health problems with their increasing prevalence in recent years. Chronic pain adds to the already enormous clinical, psychological, social and economic burden of obesity. Developing mechanisms to prevent the development of pain after TBI has attracted the attention of researchers. Obesity is a preventable and modifiable clinical condition. The extent to which obesity may create adverse conditions after TBI remains unclear.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
patients with traumatic brain injury	Other	Patients will be contacted by phone		Patients will be contacted by phone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The relationship between Bady Mass Index (BMI) and the development of chronic headache	BMI is calculated by dividing weight in kilograms by the square of height in metres.	Postoperative 3 month.

Secondary Outcomes

Measure	Description	Time Frame
The relationship between the nature of trauma and the development of chronic headache	Head traumas that occur due to different reasons will be examined	Postoperative 3 month.
The relationship between patients' education levels and chronic headache

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals over the age of 18 who suffered a head injury

Exclusion Criteria:

People with severe head trauma
Those who do not speak Turkish
Those with a history of chronic opioid user
Those with alcohol and drug addiction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

individuals over the age of 18 who suffered a head injury

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hatice Toprak	Contact	05357827688		dr.tprk@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karaman Training and Research Hospital	Recruiting	Karaman	Merkez	70200	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Sharing will be evaluated in cases where the responsible researcher is contacted.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided