- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03689205
The Effect of Obesity on Venous Puncture Pain
September 27, 2018 updated by: Hakan Tapar, Tokat Gaziosmanpasa University
Assessment of the Effect of Obesity on Venous Puncture Pain
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Observational
Enrollment (Anticipated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tokat, Turkey, 60200
- Recruiting
- Gaziosmanpasa University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
After surgery patients
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analog scale
Time Frame: one month
|
pain intensity
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2018
Primary Completion (Anticipated)
October 20, 2018
Study Completion (Anticipated)
November 20, 2018
Study Registration Dates
First Submitted
September 27, 2018
First Submitted That Met QC Criteria
September 27, 2018
First Posted (Actual)
September 28, 2018
Study Record Updates
Last Update Posted (Actual)
September 28, 2018
Last Update Submitted That Met QC Criteria
September 27, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-KAEK-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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