Effect Of Local Cold Applıcatıon On Paın and Vıtal Sıgns Durıng Port Catheter Needle Insertıon

NCT06816420 | Completed

• 1 other identifier: 23841101021
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the effect of cold application on the pain experienced during port catheter needle insertion and the change in the patient's vital signs will be evaluated. It is thought that with this application, patients will experience less pain during port catheter needle insertion. The change in the patient's vital signs and pain status will also be evaluated. The research will be conducted in the outpatient chemotherapy department of a Hospital.

Conditions

Catheter Placement and Perceived Pain; Vital Sign Monitoring; Pain

Outcome Measures

Primary Outcomes (5)

• Pain level

  patients pain levels will be assessed with a Visual analogue scale (0-10 point)

  before and in ten minutes after cold application

• Vıtal Sıgns (blood pressure, mm/Hg)

  blood pressure will be evaluated with an electronic device

  before and in ten minutes after cold application

• Vıtal Sıgns (body temperature, Celcius degree)

  body temperature will be evaluated with an electronic device

  before and in ten minutes after cold application

• Vıtal Sıgns (pulse rate in one minutes)

  pulse rate will be evaluated by researchers manually.

  before and in ten minutes after cold application

• vital signs (saturation rate, %)

  saturation rate will be evaluated with using a pulse meter

  before and in ten minutes after cold application

Study Arms (2)

Cold Applıcatıon

EXPERIMENTAL

After information about the study is provided through the informed consent form and participation approval is obtained, privacy is ensured in a single room and according to the literature review, cold application will be applied to all patients by the same nurse with ice gel for 1 minute before the application, centered on the area where the reservoir part of the port catheter is located.

Other: Cold Application

control

NO INTERVENTION

There will be no cold application before port catheter needle insertion in this group.

Interventions

Cold Application OTHER

The effects of local cold application on pain and vital signs during port catheter needle insertion will be studied in this group.

Cold Applıcatıon

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18-65, who are pain-free, receiving treatment in an outpatient chemotherapy unit, who have a port catheter, who have a Huber port needle of L (large) 20 mm-20 gauge, and who can read and write in Turkish.

You may not qualify if:

• Patients taking "oxaliplatin" Patients aged 65 and over Patients who have started using a port catheter but whose stitches have not yet healed Patients who have not passed 30 days since the port catheter was inserted Patients with any redness, swelling or tenderness in the port catheter area

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, 42090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gülden Basit, Assoc. Prof.

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study result will be analysed by an independent statistician.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doç.Dr. Gülden BASİT

Model Details: one group will be applied cold application, and the other group will not.

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: February 10, 2025
• Study Start: March 4, 2025
• Primary Completion: April 8, 2025
• Study Completion: April 8, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)