PainNCT03689205
The Effect of Obesity on Venous Puncture Pain
An observational study of Pain and Cannulation, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Cannulation, Body Mass Index
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2018to 20 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: After surgery patients
Who may be able to join
- American Society of Anesthesiologist (ASA) physical status 1 and 2, between the ages of 18 and 65, were scheduled for elective surgery
Who cannot join
- Patients with a history of anxiety disorders or hearing problem and preoperative pain, emergency surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpasa University
Tokat Province, 60200
Hakan Tapar, Assist.Prof., +905056844496, hakantapar@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Cannulation, Body Mass Index
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
pain intensity
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start20 Jun 2018
- Primary completion20 Oct 2018 (estimated)
- Study completion20 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Tapar, Tokat Gaziosmanpasa University
- Investigators
- Hakan Tapar, Principal investigator, Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689205
- Sponsor's protocol ID
- 18-KAEK-101
- Status last verified
- Sep 2018
- First submitted
- 27 Sep 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Obesity on Venous Puncture Pain
- ClinicalTrials.gov ID
- NCT03689205
- Acronym / sponsor ID
- 18-KAEK-101
- Conditions
- Pain, Cannulation, Body Mass Index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 20 Oct 2018 (estimated)
- Study completion
- 20 Nov 2018 (estimated)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- After surgery patients
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist (ASA) physical status 1 and 2, between the ages of 18 and 65, were scheduled for elective surgery
Key exclusion criteria (1 listed)
- Patients with a history of anxiety disorders or hearing problem and preoperative pain, emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual analog scale
Time frame: one month
pain intensity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Tapar principal investigator
Gaziosmanpasa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Cannulation, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hakan Tapar (03562129500 ext. 3497, hakantapar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.