- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06569004
IR Beam Used Before Peripheral Intravenous Catheter Application on Vein Visibility
August 21, 2024 updated by: Sule BIYIK BAYRAM, Karadeniz Technical University
Karadeniz Technical University - Tubitak Student Project
The study will be conducted in the Oncology and Cardiovascular Surgery (CVS) services of a university hospital.
In the research, 30 patients will constitute the control group and 30 patients will constitute the experimental group.
A nurse working in the clinics where the study will be conducted will perform the PIVK procedure, and we will randomly select the control and experimental groups and apply light to the area where the PIVK will be applied to the patients in the experimental groups with a flashlight that emits infrared rays for 10 minutes.
The nurse will not be aware of whether the radiation application was made to the patient or not.
The veins will be evaluated by the nurse performing PIVK.
We will fill out the necessary forms in ANNEX 1 (control group) and APPENDIX 2 (experimental group) while the PIVK procedure is applied.
After the procedure is completed, the patient's pain, anxiety and satisfaction level during the procedure will be marked.
The data will be entered into the SPSS program and evaluated with statistical tests.
According to the results, the effect of IR rays used before PIVK application on the patient's pain, anxiety and satisfaction and on the procedure time spent by the nurse for the application will be determined.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
A nurse from the ward where the study will be conducted will be contacted and a meeting of approximately 20 minutes will be held about the study.
The nurse will fill out the forms before and after inserting the catheter into the patient.
Routine procedures such as tourniquet, hand opening and closing will be applied to the control group before catheter application.
In the experimental group, catheter application will be made after the IR beam is applied.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Şule Bıyık Bayram, phD
- Phone Number: 4623778866
- Email: sulebiyik@gmail.com
Study Contact Backup
- Name: Merve ÇİÇEK
- Phone Number: 4633778866
- Email: mervecicek2961@gmail.com
Study Locations
-
-
-
Trabzon, Turkey
- Şule
-
Sub-Investigator:
- Hüdanur TOSUN
-
Contact:
- Merve Çiçek
- Phone Number: 4623778866
- Email: sulebiyik@gmail.com
-
-
Ortahisar
-
Trabzon, Ortahisar, Turkey, 61080
- Şule BIYIK BAYRAM
-
Contact:
- Merve Çiçek
- Phone Number: 4623778866
- Email: mervecicek2961@gmail.com
-
Sub-Investigator:
- Hüdanur TOSUN
-
-
Üniversite
-
Trabzon, Üniversite, Turkey, 61080
- Karadeniz Technical University Faculty of Health Sciences
-
Contact:
- Hüdanur Tosun
- Phone Number: 4623778866
- Email: hdnrtsnyo2325@gmail.com
-
Principal Investigator:
- Merve ÇİÇEK
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Are between the ages of 18-70,
- PIVK will be inserted,
- Not receiving anticoagulant treatment,
- Does not have diabetes or peripheral neuropathy,
- No signs of infiltration or thrombophlebitis in the extremity where IR beam will be used,
- Dialysis patients without arteriovenous fistula,
- Does not have any communication problems and whose mental level does not cause any problems in participating in the research,
- Patients who volunteer to participate in the research will be recruited.
Exclusion Criteria:
- Sudden movements during PICK insertion,
- Missing patient data
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IR beam used before peripheral intravenous catheter application on vein visibility
IR beam application
|
Use of IR beam before peripheral intravenous catheter application
Other Names:
|
|
No Intervention: control
Only parenteral catheter application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of IR beam used before peripheral intravenous catheter application
Time Frame: 6 mounths
|
question form
|
6 mounths
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of IR beam on pain
Time Frame: 6 mounths
|
Pain scale
|
6 mounths
|
|
Effect of IR beam on anxiety
Time Frame: 6 mounths
|
Anxiety scale
|
6 mounths
|
|
Effect of IR beam on satisfaction
Time Frame: 6 mounths
|
Satisfaction scale
|
6 mounths
|
|
Effect of IR beam on application
Time Frame: 6 mounth
|
Question form
|
6 mounth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sule BIYIK BAYRAM, Karadeniz Technical University
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 (Estimated)
September 1, 2024
Primary Completion (Estimated)
September 15, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
January 15, 2024
First Submitted That Met QC Criteria
August 21, 2024
First Posted (Actual)
August 23, 2024
Study Record Updates
Last Update Posted (Actual)
August 23, 2024
Last Update Submitted That Met QC Criteria
August 21, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Karadeniz Tek. Univ. 3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Questionnaire
-
AstraZenecaWithdrawnSelf-administered Questionnaire to Patients
-
Aretaieion University HospitalCompleted
-
Harvard School of Public Health (HSPH)Jingning County in Zhejiang Province in ChinaCompletedSelf Report | Questionnaire DesignChina
-
Uppsala University HospitalCompletedQuestionnaire | Fetal Scalp SamplingSweden
-
Haseki Training and Research HospitalNot yet recruitingRichards-Campbell Sleep Questionnaire (RCSQ)
-
Kutahya Health Sciences UniversityCompletedWorking Memory | The Working Memory QuestionnaireTurkey
-
University of LiegeCompletedPrimary Prevention | Shoulder | Questionnaire and SurveyBelgium
-
Rostyslav VoloshchukNot yet recruitingGeneral Anaesthesia | Validation | Postoperative Recovery | Questionnaire
-
University of LiegeRecruitingPrimary Prevention | Questionnaire and Survey | Hockey PlayerBelgium
-
Hacettepe UniversityRecruitingRadiotherapy | QuestionnaireTurkey
Clinical Trials on randomised study, two group (experimental and control)
-
Hasan Kalyoncu UniversityNot yet recruitingOsteoarthritis, KneeTurkey
-
Huang XiaolinUnknown
-
Finis Terrae UniversityNot yet recruitingPostoperative Pain | Respiratory ComplicationChile
-
The First Affiliated Hospital of Zhejiang Chinese...Not yet recruitingAdolescent Idiopathic ScoliosisChina
-
Chengdu Sport UniversityNot yet recruiting
-
Wuhan Union Hospital, ChinaRecruiting
-
Chimei Medical CenterRecruiting
-
Karadeniz Technical UniversityRecruiting
-
Inonu UniversityNot yet recruitingChronic Low-back Pain