The Effect of Obesity on Venous Puncture Pain | NCT03689205

Studies
The Effect of Obesity on Venous Puncture Pain

NCT03689205

Sponsor

Tokat Gaziosmanpasa University

Status

Unknown status

Last Update Posted

Sep 28, 2018Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Pain
Cannulation
Body Mass Index

Interventions

Not provided

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

Sep 2018

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

Jun 20, 2018Actual

Primary Completion Date

Oct 20, 2018Estimated

Completion Date

Nov 20, 2018Estimated

First Submitted Date

Sep 27, 2018

First Submission Date that Met QC Criteria

Sep 27, 2018

First Posted Date

Sep 28, 2018Actual

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

Sep 27, 2018

Last Update Posted Date

Sep 28, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Before surgery, patients will fill the Beck anxiety, distress tolerance test and Pain katastrophizing test. Patients will be divided into two groups according to BMI> 30kg / m2 (Group A) and BMI <30kg / m2 (Group B). Compared to body weight, venous vascular pain of the groups will be compared.

Detailed Description

Seventy patients will be randomized to two groups(BMI> 30kg / m2 (Group A) and BMI <30kg / m2 (Group B) during peripheral venous cannulation (PVC). The patients' visual analog scores will be measured during peripheral venous cannulation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients that BMI> 30kg / m2 (Group A)		Venous puncture pain on patients that Body mass index > 30kg / m2
Patients that BMI< 30kg / m2 (Group B)		Venous puncture pain on patients that Body mass index < 30kg / m2

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual analog scale	pain intensity	one month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologist (ASA) physical status 1 and 2, between the ages of 18 and 65, were scheduled for elective surgery

Exclusion Criteria:

Patients with a history of anxiety disorders or hearing problem and preoperative pain, emergency surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

After surgery patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hakan Tapar	Contact	03562129500	3497	hakantapar@hotmail.com
Hakan Tapar	Contact	03562129500	3497	akantapar@hotmail.com

Overall Officials

Name	Affiliation	Role
Hakan Tapar	Gaziosmanpasa University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziosmanpasa University	Recruiting	Tokat Province		60200	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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