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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06816420
Enrollment
64
Registered
2025-02-10
Start date
2025-03-04
Completion date
2025-04-08
Last updated
2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Placement and Perceived Pain, Pain, Vital Sign Monitoring

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.

Detailed description

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.

Interventions

OTHERCold Application

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

Sponsors

Necmettin Erbakan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

Study result will be analysed by an independent statistician.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain levelbefore and in ten minutes after cold applicationpatients pain levels will be assessed with a Visual analogue scale (0-10 point)
Vıtal Sıgns (blood pressure, mm/Hg)before and in ten minutes after cold applicationblood pressure will be evaluated with an electronic device
Vıtal Sıgns (body temperature, Celcius degree)before and in ten minutes after cold applicationbody temperature will be evaluated with an electronic device
Vıtal Sıgns (pulse rate in one minutes)before and in ten minutes after cold applicationpulse rate will be evaluated by researchers manually.
vital signs (saturation rate, %)before and in ten minutes after cold applicationsaturation rate will be evaluated with using a pulse meter

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026