NCT06569004

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

14 days

First QC Date

January 15, 2024

Last Update Submit

August 21, 2024

Conditions

Keywords

veinintravenousnurse

Outcome Measures

Primary Outcomes (1)

  • Effect of IR beam used before peripheral intravenous catheter application

    question form

    6 mounths

Secondary Outcomes (4)

  • Effect of IR beam on pain

    6 mounths

  • Effect of IR beam on anxiety

    6 mounths

  • Effect of IR beam on satisfaction

    6 mounths

  • Effect of IR beam on application

    6 mounth

Study Arms (2)

IR beam used before peripheral intravenous catheter application on vein visibility

EXPERIMENTAL

IR beam application

Device: randomised study, two group (experimental and control)

control

NO INTERVENTION

Only parenteral catheter application

Interventions

Use of IR beam before peripheral intravenous catheter application

Also known as: IR beam
IR beam used before peripheral intravenous catheter application on vein visibility

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Sudden movements during PICK insertion,
  • Missing patient data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Şule BIYIK BAYRAM

Trabzon, Ortahisar, 61080, Turkey (Türkiye)

Location

Şule

Trabzon, Turkey (Türkiye)

Location

Karadeniz Technical University Faculty of Health Sciences

Trabzon, Üniversite, 61080, Turkey (Türkiye)

Location

Study Officials

  • Sule BIYIK BAYRAM

    Karadeniz Technical University

    STUDY DIRECTOR

Central Study Contacts

Şule Bıyık Bayram, phD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor Karadeniz Technical University

Study Record Dates

First Submitted

January 15, 2024

First Posted

August 23, 2024

Study Start

September 1, 2024

Primary Completion

September 15, 2024

Study Completion

September 30, 2024

Last Updated

August 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations