QuestionnaireNCT06569004
IR Beam Used Before Peripheral Intravenous Catheter Application on Vein Visibility
A study of Questionnaire, run by Karadeniz Technical University at 3 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Questionnaire
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 30 Sep 2024
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Sudden movements during PICK insertion,
- Missing patient data
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Şule BIYIK BAYRAM
Trabzon, Ortahisar, 61080
Merve Çiçek, 4623778866, mervecicek2961@gmail.com
Hüdanur TOSUN
Şule
Trabzon
Merve Çiçek, 4623778866, sulebiyik@gmail.com
Hüdanur TOSUN
Karadeniz Technical University Faculty of Health Sciences
Trabzon, Üniversite, 61080
Hüdanur Tosun, 4623778866, hdnrtsnyo2325@gmail.com
Merve ÇİÇEK
About this study
Official title: 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.
Read the 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.
- Conditions
- Questionnaire
- Being tested
- randomised study, two group (experimental and control)
- Keywords
- vein, intravenous, nurse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
randomised study, two group (experimental and control)Device
Also called IR beam
Use of IR beam before peripheral intravenous catheter application
| Study group | Role | What they receive |
|---|---|---|
| IR beam used before peripheral intravenous catheter application on vein visibility | Experimental | IR beam application Receives: Device: randomised study, two group (experimental and control) |
| control | No intervention | Only parenteral catheter application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of IR beam used before peripheral intravenous catheter application
question form
Measured: 6 mounths
Secondary outcomes (4)
Effect of IR beam on pain
Pain scale
Measured: 6 mounths
Effect of IR beam on anxiety
Anxiety scale
Measured: 6 mounths
Effect of IR beam on satisfaction
Satisfaction scale
Measured: 6 mounths
Effect of IR beam on application
Question form
Measured: 6 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion15 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QuestionnaireStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sule BIYIK BAYRAM, Karadeniz Technical University
- Investigators
- Sule BIYIK BAYRAM, Study director, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569004
- Sponsor's protocol ID
- Karadeniz Tek. Univ. 3
- Status last verified
- Aug 2024
- First submitted
- 15 Jan 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Karadeniz Technical University - Tubitak Student Project
- ClinicalTrials.gov ID
- NCT06569004
- Acronym / sponsor ID
- Karadeniz Tek. Univ. 3
- Conditions
- Questionnaire
- Keywords
- vein, intravenous, nurse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 23 Aug 2024 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IR beam used before peripheral intravenous catheter application on vein visibility | Experimental | Device: randomised study, two group (experimental and control)IR beam application |
| control | No intervention | –Only parenteral catheter application |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (2 listed)
- Sudden movements during PICK insertion,
- Missing patient data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| randomised study, two group (experimental and control)Also: IR beamUse of IR beam before peripheral intravenous catheter application | Device | IR beam used before peripheral intravenous catheter application on vein visibility |
Primary outcome
Effect of IR beam used before peripheral intravenous catheter application
Time frame: 6 mounths
question form
4 secondary outcomes
Effect of IR beam on pain
Time frame: 6 mounths
Effect of IR beam on anxiety
Time frame: 6 mounths
Effect of IR beam on satisfaction
Time frame: 6 mounths
Effect of IR beam on application
Time frame: 6 mounth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Sule BIYIK BAYRAM study director
Karadeniz Technical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Questionnaire, run by Karadeniz Technical University at 3 sites 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 8 inclusion and 2 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 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Şule Bıyık Bayram, phD (4623778866, sulebiyik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of IR beam used before peripheral intravenous catheter application (time frame: 6 mounths). 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 23 Aug 2024.