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Completed

NCT Number: NCT06816420

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

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.

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Key information

Conditions

Catheter Placement and Perceived Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vital Sign Monitoring

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University

Konya, Meram, 42090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pain level

    Time frame: before and in ten minutes after cold application

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

  2. Vıtal Sıgns (blood pressure, mm/Hg)

    Time frame: before and in ten minutes after cold application

    blood pressure will be evaluated with an electronic device

  3. Vıtal Sıgns (body temperature, Celcius degree)

    Time frame: before and in ten minutes after cold application

    body temperature will be evaluated with an electronic device

  4. Vıtal Sıgns (pulse rate in one minutes)

    Time frame: before and in ten minutes after cold application

    pulse rate will be evaluated by researchers manually.

  5. vital signs (saturation rate, %)

    Time frame: before and in ten minutes after cold application

    saturation rate will be evaluated with using a pulse meter

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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