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

NCT ID: NCT06816420

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-04

Study Completion Date

2025-04-08

Brief Summary

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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.

Detailed Description

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The effects of lidocaine cream, cryotherapy (cold application to the skin), cutaneous stimulation therapy (pressure and massage) methods , virtual reality application and aromatherapy applied via inhalation on reducing pain were investigated in order to reduce the pain during port catheter needle insertion. 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 according to the pain status will also be evaluated. The research will be conducted in the outpatient chemotherapy department of Necmettin Erbakan University Faculty of Medicine Hospital. The universe of the research will consist of all patients with port catheters in the outpatient chemotherapy department of Necmettin Erbakan University Faculty of Medicine Hospital. The sample of the research will consist of patients who meet the inclusion criteria and agree to participate in the research.

Conditions

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Catheter Placement and Perceived Pain Vital Sign Monitoring Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

one group will be applied cold application, and the other group will not.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Study result will be analysed by an independent statistician.

Study Groups

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Cold Applıcatıon

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.

Group Type EXPERIMENTAL

Cold Application

Intervention Type OTHER

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

control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cold Application

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

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Gulden Basit

Doç.Dr. Gülden BASİT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülden Basit, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Necmettin Erbakan University

Locations

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Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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23841101021

Identifier Type: -

Identifier Source: org_study_id

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